As Life Science professionals with niche skills sets our clients are provided with an innovative, network based, qualitative service that produces results on hard to fill roles. The professionals we engage with are provided with invaluable technical and cultural insight into client companies ensuring they are sufficiently prepared to successfully engage in hiring processes. Our technical expertise across numerous verticals within the sector further enables us to interact on a meaningful basis with key decision makers so that we fully understand strategic technical and cultural fits.


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RECRUITMENT

CLIENT

Aphex’s industry experienced resourcing professionals have hands on experience working within Validation, Laboratories, Supply Chain, Procurement, Automation functions within the Life Sciences sector. Our professional qualification and verification approach ensures clients receive the most qualified professional. Contact us to manage your resourcing requirements.

PROFESSIONALS

Our value add is simple, you will be engaging with professionals that have proven and current experience of the Life Sciences industry with strong insights to client companies. This ensures that ambitious professionals are briefed and prepared accordingly throughout the rigours of the interview process, thus enhancing the probability of securing their next position.

PROFESSIONALS

Our value add is simple, you will be engaging with professionals that have proven and current experience of the Life Sciences industry with strong insights to client companies. This ensures that ambitious professionals are briefed and prepared accordingly throughout the rigours of the interview process, thus enhancing the probability of securing their next position.

AVAILABLE VACANCIES

12235 – Senior Project Engineer - Carlow

Purpose:

The QC Bioassay Analyst role is a critically important activity to ensure efficient and effective compliant design, construction, qualification, and operation of facility. This tremendous opportunity will be part of the Bioassay team responsible for qualifying the Bioassay analytical lab and the transfer of Bioassay analytical methods. This person will be key in the layout of the lab testing to ensure the process is streamlined and in line with company lean methodologies. Additional development opportunities within the micro and chemistry lab will be strongly considered to recognize the tremendous value of knowledge / experience gained by the candidate during the project phases. To maximize the development opportunity, the candidate will be key talent in analytical Bioassay techniques and developing the flow of testing through the lab, to ensure the lab will be best in class across our industry, a benchmark for others to aspire to. The candidate will support the complete analytical lab build. The full analytical scope will incorporate micro, chemistry, mycoplasma, bioassay, raw materials, stability and in-process. Innovation and advanced analytical methods (rapid ID technics, paperless lab, etc) will allow the candidate challenge current thinking in designing for the future. The candidate will participate in analytical transfer and qualification of methods.

Responsibilities:

  • Perform activities for general lab readiness, laboratory equipment qualification and method transfers.
  • Strong knowledge and experience of Bioassay methods.
  • Perform and carry out a variety of analytical techniques including but not limited to Potency Elisa test in compliance with GMP requirements.
  • Follow up-to-date analytical practices with reference specifications, regulations and industry standards.
  • Receive and manage samples that come into the lab for stability, in-process and release testing.
  • Writing and update of SOPs.
  • Maintain good housekeeping and hygiene within the laboratory.
  • Cleaning and routine equipment maintenance.
  • Participate in risk assessments, inspections, audits, incident investigations, etc. and implement and follow-up on corrective / preventative measures.
  • Ensure training is current for all job functions performed.
  • Assist in training new QC Analysts on routine procedures and practices.
  • Order, stock and receive laboratory supplies.
  • Maintain data integrity and ensure compliance with company SOPs, specifications and cGMP regulations.
  • Ensure that cGMP standards are maintained at all times.
  • Delivery of area performance to meet or exceed performance or quality goals.
  • Promote and participate the implementation and maintenance of the relevant safety programmes.
  • Participate and comply with the company’s Quality Management System requirements.
  • Drive a culture of Continuous Improvement by deploying company Six Sigma tools.
  • Assist in the “operationalising” of the lab with a strong focus on MPS.
  • This position will be on days with the possibility of shift work when required.

 

Minimum Qualifications and Experience:

  • Degree qualification (Science/Quality/Technical.)
  • 3 years minimum industry experience with significant knowledge and experience working in a QC laboratory testing environment within the biological and/or pharmaceutical industry.
  • Experience in Potency, Residual protein A and HCP Elisa method.
  • Demonstrated knowledge and testing experience in an FDA/HPRA approved QC laboratory.
  • Good working knowledge of QC Systems (SoftMax Pro, Gen5, EN, LIMS) and Trackwise.
  • Preference Lean Six Sigma.

 

 

12235 – Senior Project Engineer - Carlow

Responsibilities:

  • The Senior Project Engineer will be a key member within the Project Team providing Project Management leadership, guidance and expertise to ensure successful project completion.
  • The Senior Project Engineer will be required to plan and coordinate project activities to ensure the effective and efficient on-time delivery of the projects.
  • Develop project objectives by reviewing project proposals and plans; conferring with management.
  • Determines project responsibilities by identifying project phases and elements; assigning personnel to phases and elements; reviewing bids from contractors.
  • Determines project specifications by studying product design, customer requirements, and performance standards; completing technical studies; preparing cost estimates.
  • Determines project schedule by studying project plan and specifications; calculating time requirements; sequencing project elements.
  • Maintains project schedule by monitoring project progress; coordinating activities; resolving problems.
  • Controls project plan by reviewing design, specifications, and plan and schedule changes; recommending actions.
  • Controls project costs by approving expenditures; administering contractor contracts.
  • Prepares project status reports by collecting, analyzing, and summarizing information and trends; recommending actions.
  • Maintains safe and clean working environment by enforcing procedures, rules, and regulations.
  • Maintains project data base by writing computer programs; entering and backing up data.
  • Contributes to team effort by accomplishing related results as needed.

 

Minimum Qualifications and Experience:

  • Degree qualification (Mechanical Engineering, Science, Technical.)
  • Project management qualification such as, Project Management Professional.
  • 7+ years process / project management experience.
  • Desirable: Evidence of Continuous Professional Development.
  • Preference for Lean Six Sigma Green Belt.
  • Strong verbal, technical writing, project management and interpersonal skills are required.
  • Demonstrated knowledge in pharmaceutical / biopharmaceutical technical / manufacturing operations.
  • Experience of involvement in a technical project and advantage.
  • Knowledge of Regulations and Change Control within the pharmaceutical industry.
  • Demonstrated knowledge in more than one pharmaceutical or Biopharmaceutical operation (e.g. manufacturing, technology, validation, engineering.)
  • Knowledge of Technology Transfer within pharmaceutical industry.
  • Stakeholder management of multi decision makers, colleagues, peers and cross functional teams.
  • Experience in a FDA / HPRA Regulated production environment.

 

 

11119035 – Technical Service Specialist (General) - Dublin

Purpose:

The Technical Specialist, BDS Technical Services has primary responsibility for providing scientific & technical support of (cell culture derived) drug substance manufacturing processes performed at the site, specifically the technology transfer of product(s) into the site. The successful candidate will be responsible for providing scientific and technical support through all phases of the product lifecycle, including technology transfer, process scale-up, process validation, routine manufacturing, and process/continual improvement programs. The position requires effective cross-functional collaboration with external contractors and internal partners including Manufacturing, Process Development, Engineering, Regulatory, QC and Quality to provide support of manufacturing of BDS.

Responsibilities:

  • Provide process information and analysis to facilitate process/facility fit, and qualification of a large scale BDS facility through to NPI tech transfer startup, PPQ validation, in a multi-product BDS facility.
  • Participate in Tech Transfer Receiving Unit activities, and provide technical guidance to team members in large scale cell culture/downstream purification processes, and provide SME support for the area on key audit topics.
  • Provide scientific and technical input to facilitate decision making related to Tech Transfer.
  • Develop/provide deep technical knowledge and understanding in cell culture processes; vial thaw, seed expansion, seed reactors and large scale production bioreactors, including centrifugation and depth filtration steps, or downstream purification processes; large scale column chromatography steps, ultrafiltration/diafiltration steps, pH adjustment, depth/nanofiltration steps, and final fill.
  • Undertake technical risk assessments to support raw material assessment for NPI.
  • Identify technical issues, and guide resolution of same.
  • Provide SME knowledge and understanding in BDS manufacturing processes (upstream/downstream); cause and effect, scale up principles, QRM, and process validation strategies.
  • Shape and develop strategy approaches for Technical Services in areas such as cell culture and downstream purification processes, technical studies supporting facility fit and regulatory filings, Technology Transfer, PPQ, CPV approach and so forth ensuring alignment to industry regulations, trends and advances.
  • Ensure current with Regulatory changes, and industry trends, ensuring robust and scientifically sound rationale and justifications applied to the company’s manufacturing processes. Develop and shape standards and strategy documents to support BDS Manufacturing and Tech Transfer.
  • Collaborate with Process Development and Engineering to influence the design and implementation of a robust process control strategy, complete process risk assessments and associated documentation to support equipment qualification activities, PPQ studies and key technical strategies.
  • Engage with internal partners on pipeline processes for manufacturability.
  • Be a QRM Risk facilitator/mentor for others, aligning approaches to risk assessment per company procedures.
  • Perform risk assessments to support the technology transfer e.g. pFMEA’s and other risk tools.
  • Provide Technical input, review/approval into documentation associated with New Material Introduction, Manufacturing control and enterprises systems (MCS/MES) including manufacturing batch records, work instructions, competencies, and other related Technical documentation.
  • Ongoing technical support of Manufacturing Operations by providing technical expertise for investigation and resolution of process deviations, CAPAs, review and approval of change controls.
  • May be required to work periodically out of normal business hours (temporary shift working or per out of hours policy) during periods of engineering and validation batch execution, as well as any other duties as required.
  • Short duration Person in Plant (PIP) observation may be required at sending units/existing facilities to support Tech Transfer into the site.
  • Author, review and approval of reports which may support CMC sections for regulatory agency submissions and responses (as required.)
  • Contribute to successful regulatory agency inspections by providing subject-matter expertise on mammalian cell culture/downstream purification, technology transfer and manufacturing processes.
  • Help develop first class technical/scientific staff to maintain a high level of current technical expertise within the Technical Services team.
  • Identify and implement continual improvement initiatives.
  • Any other duties as required by management.

 

Minimum Qualifications and Experience:

  • Minimum undergraduate degree in chemistry, biology, engineering or related discipline.
  • An advanced degree (MS, PhD) in Scientific (Biochemistry, Biology, Chemistry, Pharmacy) or Engineering (Chemical, Mechanical) related field is desirable.
  • Minimum of 8 years+ experience in a pharmaceutical manufacturing organization, with expertise in Bulk Drug Substance manufacturing, with previous experience in cell culture unit operations or downstream unit operations, process/facility fit, New Product Introduction Technology Transfer. Previous experience of a technology transfer participated is advantageous.
  • In-depth technical and operational knowledge of multiple unit operations in cell culture processing, centrifugation, depth filtration.
  • Understanding of cause and effect of cell culture metabolism, or downstream processing with chromatography, UFDF, viral filtration and sub-micron filtration, pH adjustment and final fill.
  • Understanding of analytical methods and corresponding signals to enable control strategy development and improvement.
  • Strong understanding of technology transfer, bioreactor scale-up process or scaling principles for downstream unit operations.
  • Comprehensive understanding of cGMP requirements for clinical/commercial biopharmaceutical manufacturing and the ability to implement best practices to ensure multi-product bulk drug manufacturing operations are cGMP compliant.
  • Experience of Validation / Verification of GMP equipment or processes would be beneficial.
  • Experience of process/facility fit, design, commissioning and start-up of a bulk drug substance facility is beneficial.
  • Strong interpersonal skills coupled with demonstrated ability to effectively work in a cross-functional global environment matrix organization, and in local group settings.
  • Ability to develop, build, present and defend technical and scientific approaches in both written and verbal form.
  • Can effectively partner with and influence stakeholders without direct solid line authority. Drives technical decisions balancing product quality and operational requirements.
  • Ability to drive for results independently and adapt to rapidly changing priorities.
  • Experience of Technology Transfer activities is advantageous.
  • Knowledge or experience of start-up or systems would be ideal.
  • Excellent communication skills, and able to effectively influence across all levels of the organization both internal and external to the company.
  • Detail orientated.
  • Technical writing competency.
  • Excellent organizational skills with strategic thinking and vision for the group.
  • Demonstrated ability to drive for results and lead innovation and change.
  • Self-driven, able to prioritize, and to orchestrate multiple activities at once.
  • Consistently demonstrate sound business judgment when making decisions.
  • Ability to deal with ambiguity and complexity and influence others across levels of the organization.

 

 

Associate Director - Inspection Management - Limerick

Purpose:

The individual will provide support during regulatory inspections and internal audits. This individual will also work to ensure that all identified content is organized, current and readily accessible in the event of an inspection or audit purposes. Additionally, the individual will work with department leaders to build an inspection readiness capability across the organization.

Responsibilities:

  • Inspection Readiness:
    • Benchmark leading practices and recommend improvements to make IOPS inspection-ready at all times.
    • Maintain and organize inspection readiness content, including building and maintaining a content repository, to ensure quick access to materials in the event of inspection or audit.
    • Build and implement tools to improve IOPS inspection readiness.
    • Identify trends in recent regulatory inspections and translate this to recommendations to enhance readiness.
    • Work closely with other regulatory compliance team to close gaps and improve inspection readiness capabilities.
  • Inspection Execution:
    • Liaison with regulatory bodies, partners and key suppliers on audit, regulatory, and quality related matters and to provide guidance and advice to partners, suppliers and internal associates on regulatory and quality matters.
    • Respond to incoming inquires during inspections and audits and ensure timely and accurate responses.
  • Ensure marketed products are in compliance with global regulatory and guidance requirements primarily US and secondarily EU.
  • Define and implement quality standards, systems, and metrics for maintaining regulatory compliance for clinical and commercial operations.
  • Interfaces with customer/partner quality organizations.
  • Participates on internal committees/teams, as required.
  • Provides advice and direction to other company departments on quality and regulatory issues.

 

Minimum Qualifications and Experience:

  • Requires BA/BS degree in in chemical engineering/chemistry/life sciences.
  • Process engineering or validation background & experience desired.
  • 8-10+ years of relevant experience in a biotech or pharmaceutical environment.

 

 

21330 – Associate Manager – Process Sciences - Limerick

Purpose:

Lead a team to manage all activities to ensure that manufacturing processes are supported. Responsible to support the Process Sciences Department through Process Validation, manufacturing floor support, product impact assessments, investigations, and technical evaluation as required. Active member of the Process Sciences management team.

Responsibilities:

  • Lead a team and manage all activities to assure that manufacturing processes are supported.
  • Responsible for developing a team such as development plans, upskilling and team forming.
  • Write, review and approve Process Validation protocols and reports.
  • Identification of process parameters and appropriate ranges to be included in process validation.
  • Provide on the floor support to Manufacturing (Cell culture and Purification)
  • Lead/Participate Process and Quality risk assessments.
  • Lead troubleshooting activities associated with the manufacturing process.
  • Provide technical support for manufacturing personnel to improve understanding of both cell culture and purification operations.
  • Review and approve manufacturing documentation such as manufacturing records, SOPs and batch sheets.
  • Develops/writes/plans and reviews protocols and activities for manufacturing support.
  • Serves as a subject matter expert (SME) for data trending and manufacturing support.
  • Presents and reviews process monitoring data to IOPS Management as necessary.
  • Investigates and reviews OOS and OOL IPCs investigations.
  • Performs, reviews and approves product impact assessment.
  • Performs, reviews and approves scientific investigations (EOE & DNF.)
  • Communicate information on current process data and other IOPS initiatives which may impact process development and/or technology transfer.
  • Support the site through regulatory audits by providing technical expertise.
  • Work efficiently and effectively in a fast-paced team-oriented environment to ensure maximum and high-quality output.

 

Minimum Qualifications and Experience:

  • BS/BA in a related field.
  • 6+ years of related experience in a GMP environment.
  • Previous experience in biological drug substance (DS) manufacturing.

 

#aphex

21350 – Senior Process Scientist – Cell Culture - Limerick

Purpose:

Supports the Process Sciences Department through small scale laboratory experiments, as well as analysis, troubleshooting, and validation of manufacturing bioprocesses.

Responsibilities:

  • Provides technical support for Technology transfer cell culture activities.
  • Performs cell culture investigations in the laboratory and creates associated reports.
  • Develops and writes responses for technical sections of Regulatory documents.
  • Conducts scaled-down production procedures to improve the efficiency and yield of candidate or existing bioprocesses.
  • Develops and writes protocols for small-scale process validation studies.
  • Carries out small-scale cell culture process validation studies.
  • Assists in the analysis of samples generated from lab scale studies.
  • Tabulates results and writes summary reports of process evaluation and validation studies.
  • Presents findings at group and possibly at interdepartmental meetings.
  • Maintains lab supplies and equipment.
  • Produces and maintains accurate records.
  • Provides coaching and mentoring to junior members of the team.

 

Minimum Qualifications and Experience:

  • PhD in Biotechnology, Biochemistry, Chemical Engineering or a related field with 3+ years’ experience.
  • Or an MSc Biotechnology or related field with 6+ years’ experience.
  • Experience in a biopharmaceutical setting is desirable.
  • May consider another discipline with added relevant experience.

 

 

21287 – Senior GMP Auditor - Limerick

Purpose:

Responsible for planning and conducting quality audits in manufacturing (GMP) within designated Quality Auditing area.

Responsibilities:

  • Schedules, prepares, and conducts audits in support of GMP as directed.
  • Assembles and coordinates the activities of the audit team.
  • Conducts audits in accordance with the company’s standard operating procedures and quality policies.
  • Interprets policies, standards, and regulations, and then evaluates potentially critical problems not covered by the policies, standards, and regulations.
  • Ensures that written procedures are followed, and exercises judgment in evaluating quality systems, processes, procedures, and protocols for compliance.
  • Escalates any compliance issues.
  • Communicates audit results to management and auditees through written audit reports.
  • Manages post-audit activities, and follows up on any necessary corrective and preventive actions by resolving any conflicts.
  • Assists with hosting regulatory facility inspections by acting as a scribe and/or document reviewer.
  • Drafts and issues periodic reports to site management as requested.
  • Assists with training/orientation for new Quality Auditing staff.
  • Supervises junior auditors.
  • Ability to stand and walk for extended periods of time
  • This position requires 50% travel.

 

Minimum Qualifications and Experience:

  • BS/BA with 2-5+ years of related experience in Biotech/Pharmaceutical industry.
  • 2-5 years of audit experience in GMP environment preferred.
  • Other relevant experience may be considered in lieu of degree.

 

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21341 – Process Scientist – Process Data - Limerick

Purpose:

Lead data strategy and data analytics projects within the team. Projects include system integration with new data sources and upgrades associated the deployment of the Discoverant System a software that is used to extract, monitor, analyse and report data from multiple source systems. Ability to perform and/or lead others in projects to complete data sourcing, capturing design requirements, data entry, data verification and validation activities associated with these projects.

Responsibilities:

  • Responsible for documentation associated with a development project: writing design requirements and testing documentation and updating system documentation as required.
  • Develops use cases and user acceptance criteria and lead user acceptance testing activities in support of the development of data solutions.
  • Collaborates with cross-functional departments to co-ordinate data sourcing. Design, development and validation activities.
  • Collaborate with cross-functional departments to resolve issues and deploy solutions and facilitate continuous improvement opportunities.
  • Ability to make informed and timely decisions with minimal supervision.
  • Co-ordinate and prioritise project tasks and operation tasks within the team.

 

Minimum Qualifications and Experience:

  • Requires an MS in mathematics, engineering, information technology, business information systems, computer science or related field with 4+ years of experience / BS with 5+ years of experience.
  • May consider another degree discipline with relevant experience.
  • Experience in a biopharmaceutical setting is desirable.

 

21344 – Process Scientist – Cell Culture - Limerick

Purpose:

Supports the Process Sciences Department through small scale laboratory experiments, as well as analysis and troubleshooting of manufacturing bioprocesses.

Responsibilities:

  • Performs technical mammalian cell culture investigations in the laboratory and creates associated reports.
  • Conducts scaled-down production procedures to improve the efficiency and yield of candidate or existing bioprocesses.
  • Performs small scale mammalian media lot screening studies to ensure successful manufacturing runs.
  • Assists in the analysis of samples generated from lab scale studies.
  • Tabulates results and writes summary reports of process evaluation and validation studies.
  • Maintains lab supplies and equipment.
  • Develops and writes protocols for small-scale process validation studies.
  • Carries out small-scale process validation studies.
  • Develops and writes responses for technical sections of Regulatory documents.
  • Produces and maintains accurate records.
  • Presents findings at group and possibly at interdepartmental meetings.

 

Minimum Qualifications and Experience:

  • PhD in Biotechnology, Biochemistry, or a related field with 0-2 years’ experience.
  • Or MSc in Biotechnology, Biochemistry or a related field with 3+ year’s relevant experience.
  • May consider another discipline with added relevant experience.
  • cGMP experience is desirable.

 

21343 – Process Scientist – IPC Lifecycle Management - Limerick

Purpose:

Supports, develops and maintains in-process control (IPC) programs for manufacturing bioprocesses as part of Process Sciences Department.

Responsibilities:

  • Collates and analyzes data from development studies, process validation and characterization studies, historical process data, investigative findings and process risk assessments to develop In-Process Control (IPC) programs.
  • Applies statistical process control tools for limit establishment and monitoring of the manufacturing process.
  • Contributes to scientific analysis of results generated from laboratory-scale, and manufacturing-scale studies, including determination of possible mechanisms of process behavior in cell culture and/or purification systems.
  • Communicate information on current process data and other IOPS initiatives which may impact process development and/or technology transfer.
  • Participates in process and quality risk assessments.
  • Presents findings, limit setting strategies, and process monitoring data at group, departmental, and interdepartmental meetings as necessary.
  • Assists in troubleshooting activities associated with the manufacturing process.
  • Supports technology transfer activities as needed.
  • Support CMC Regulatory Sciences in developing and writing of responses for technical sections of regulatory documents.
  • Presents findings at group and interdepartmental meetings.

 

Minimum Qualifications and Experience:

  • PhD in Biotechnology, Biochemistry or a related field with 0-2 years’ experience.
  • Or MSc in Biotechnology, Biochemistry or a related field with 4+ year’s relevant experience.
  • May consider another discipline with added relevant experience.
  • cGMP experience is desirable.

 

21333 – Process Sciences Manager – Process Monitoring - Limerick

Purpose:

Supports the Process Sciences Department through process monitoring and statistics. To establish, organise and maintain effective statistics and data evaluation services pertaining to process monitoring and modelling of biological drugs, as well as promoting the use of statistical thinking across the site.

Responsibilities:

  • Lead the process monitoring and statistics team, and manage all activities to assure that manufacturing processes are supported.
  • Responsible for ensuring verified process data is available and easily accessible across departments.
  • Tech transfer, implementation and oversee the site’s Discoverant program and ensure that it meets all organizational needs.
  • Apply statistical process control to clinical and commercial process data.
  • Presents and reviews process monitoring data to IOPS Management as necessary.
  • Work with cross-functional departments to ensure process data is being used to maximize process understanding and facilitate continuous improvement opportunities (i.e. real time process monitoring.)
  • Serve as a primary contact for process data and key facility information.
  • Assists in troubleshooting activities associated with the manufacturing process that involves data analysis.
  • Ensure information requests for data from the IOPS site is provided in an accurate, complete, and timely manner.
  • Involve the correct subject matter experts (SMEs) to answer detailed information requests and help troubleshoot unexpected process performance.
  • Communicate information on current process data and other IOPS initiatives which may impact manufacturing, process development and/or technology transfer.

 

Minimum Qualifications and Experience:

  • BS/BA in related field.
  • 7+ years of relevant industry experience and some previous supervisory experience; equivalent combination of advanced education and experience may be considered.

 

#aphex

11224813 – Specialist Technical Services - Dublin

Purpose:

The Technical Specialist, BDS Technical Services has primary responsibility for providing scientific & technical support of (cell culture derived) drug substance manufacturing processes performed at the site, specifically the technology transfer of product(s) into the site. The successful candidate will be responsible for providing scientific and technical support through all phases of the product lifecycle, including technology transfer, process scale-up, process validation, routine manufacturing, and process/continual improvement programs. The position requires effective cross-functional collaboration with external contractors and internal partners including Manufacturing, Process Development, Engineering, Regulatory, QC and Quality to provide support of manufacturing of BDS.

Responsibilities:

  • Provide process information and analysis to facilitate process/facility fit, and qualification of a large scale BDS facility through to NPI tech transfer startup, PPQ validation, in a multi-product BDS facility.
  • Participate in Tech Transfer Receiving Unit activities, and provide technical guidance to team members in large scale cell culture/downstream purification processes, and provide SME support for the area on key audit topics.
  • Provide scientific and technical input to facilitate decision making related to Tech Transfer.
  • Develop/provide deep technical knowledge and understanding in cell culture processes; vial thaw, seed expansion, seed reactors and large scale production bioreactors, including centrifugation and depth filtration steps, or downstream purification processes; large scale column chromatography steps, ultrafiltration/diafiltration steps, pH adjustment, depth/nanofiltration steps, and final fill.
  • Undertake technical risk assessments to support raw material assessment for NPI.
  • Identify technical issues, and guide resolution of same.
  • Provide SME knowledge and understanding in BDS manufacturing processes (upstream/downstream); cause and effect, scale up principles, QRM, and process validation strategies.
  • Shape and develop strategy approaches for Technical Services in areas such as cell culture and downstream purification processes, technical studies supporting facility fit and regulatory filings, Technology Transfer, PPQ, CPV approach and so forth ensuring alignment to industry regulations, trends and advances.
  • Ensure current with Regulatory changes, and industry trends, ensuring robust and scientifically sound rationale and justifications applied to company manufacturing processes. Develop and shape standards and strategy documents to support BDS Manufacturing and Tech Transfer.
  • Collaborate with Process Development and Engineering to influence the design and implementation of a robust process control strategy, complete process risk assessments and associated documentation to support equipment qualification activities, PPQ studies and key technical strategies.
  • Engage with internal partners on pipeline processes for manufacturability.
  • Be a QRM Risk facilitator/mentor for others, aligning approaches to risk assessment per company procedures.
  • Perform risk assessments to support the technology transfer e.g. pFMEA’s and other risk tools.
  • Provide Technical input, review/approval into documentation associated with New Material Introduction, Manufacturing control and enterprises systems (MCS/MES) including manufacturing batch records, work instructions, competencies, and other related Technical documentation.
  • Ongoing technical support of Manufacturing Operations by providing technical expertise for investigation and resolution of process deviations, CAPAs, review and approval of change controls.
  • May be required to work periodically out of normal business hours (temporary shift working or per out of hours policy) during periods of engineering and validation batch execution, as well as any other duties as required.
  • Short duration Person in Plant (PIP) observation may be required at sending units/existing facilities to support Tech Transfer into the site.
  • Author, review and approval of reports which may support CMC sections for regulatory agency submissions and responses (as required.)
  • Contribute to successful regulatory agency inspections by providing subject-matter expertise on mammalian cell culture/downstream purification, technology transfer and manufacturing processes.
  • Help develop first class technical/scientific staff to maintain a high level of current technical expertise within the Technical Services team.
  • Identify and implement continual improvement initiatives.
  • Any other duties as required by management.

 

Minimum Qualifications and Experience:

  • Minimum undergraduate degree in chemistry, biology, engineering or related discipline.
  • An advanced degree (MS, PhD) in Scientific (Biochemistry, Biology, Chemistry, Pharmacy) or Engineering (Chemical, Mechanical) related field is desirable.
  • Minimum of 8 years+ experience in a pharmaceutical manufacturing organization, with expertise in Bulk Drug Substance manufacturing, with previous experience in cell culture unit operations or downstream unit operations, process/facility fit, New Product Introduction Technology Transfer. Previous experience of a technology transfer participated is advantageous.
  • In-depth technical and operational knowledge of multiple unit operations in cell culture processing, centrifugation, depth filtration.
  • Understanding of cause and effect of cell culture metabolism, or downstream processing with chromatography, UFDF, viral filtration and sub-micron filtration, pH adjustment and final fill.
  • Understanding of analytical methods and corresponding signals to enable control strategy development and improvement.
  • Strong understanding of technology transfer, bioreactor scale-up process or scaling principles for downstream unit operations.
  • Comprehensive understanding of cGMP requirements for clinical/commercial biopharmaceutical manufacturing and the ability to implement best practices to ensure multi-product bulk drug manufacturing operations are cGMP compliant.
  • Experience of Validation / Verification of GMP equipment or processes would be beneficial.
  • Experience of process/facility fit, design, commissioning and start-up of a bulk drug substance facility is beneficial.
  • Strong interpersonal skills coupled with demonstrated ability to effectively work in a cross-functional global environment matrix organization, and in local group settings.
  • Ability to develop, build, present and defend technical and scientific approaches in both written and verbal form.
  • Can effectively partner with and influence stakeholders without direct solid line authority. Drives technical decisions balancing product quality and operational requirements.
  • Experience of Technology Transfer activities is advantageous.
  • Knowledge or experience of start-up or systems would be ideal.
  • Excellent communication skills, and able to effectively influence across all levels of the organization both internal and external to the company.
  • Technical writing competency.
  • Demonstrated ability to drive for results and lead innovation and change.

 

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Packaging Operators - Waterford

Purpose:

5 positions open. Temporary positions needed until Christmas. 2x shift cycle

 

Minimum Qualifications and Experience:

  • Previous experience in GMP environment desirable.
  • Previous packaging/pharma experience required.

 

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11214679 – QA Manager - Dublin

Purpose:

Responsible for supporting the day-to-day audit program. This position will manage the audit process from end-to-end, liaising with all relevant stakeholders across the business to ensure timely scheduling, execution and close-out of the annual audit schedules. The position will ensure that audit metrics are compiled and maintained in order to achieve the required state of compliance. This data feeds into risk assessment activities across the Quality Management System (QMS) and gives senior management visibility into the health of audit activities across the company.

Responsibilities:

  • Compilation of annual supplier (both internal and external) risk assessments used to generate to cyclical audit schedule.
  • Reviews and risk assesses new and existing supplier audit requests from various business process owners.
  • Maintains an up to date global audit schedule and generates periodic metric reports suitable for viewing by and presentation to Senior Management.
  • Liaises with contractor and internal auditors to provide adequate detail of and expectations for upcoming audits.
  • Manages the initiation, assignment, execution and close-out of all audit observations and related CAPA responses.
  • Participates in and performs audits when required.
  • Contributes to the further development of the audit function by shaping the company’s audit landscape through proposals and innovative solutions.
  • Generates and maintains departmental SOPs.
  • For internal audits, partners with internal stakeholders to understand the individual department/process requirements, in order to construct meaningful and focused audit agendas.
  • Partners with the Supplier Quality group to ensure seamless on-boarding of new suppliers.

 

Minimum Qualifications and Experience:

  • Bachelor’s Degree in Business or Life sciences is required.
  • Minimum 2 years pharmaceutical or biotechnology industry experience in a quality function.
  • Experience coordinating audit programs and participating in audits.
  • Proficient knowledge of the pharmaceuticals GxP regulations and standards.
  • Experience with Trackwise, Veeva and use of pivot tables would be an advantage.
  • Excellent verbal and written communication skills.
  • Ability to partner with Business Peers with a focus on collaboration and delivering results.

 

#aphex

12221 – HR Analyst II - Dublin

Purpose:

Reports directly to the Delivery Assurance Sr Specialist and is responsible for process design and development; creation of knowledge management materials and the deployment of new processes into the business as usual environment.

Responsibilities:

  • Review and analysis of acquired company processes to understand and document local requirements within the context of global, regional and sub-regional process templates.
  • Creation of knowledge management materials to drive better understanding of key stakeholders as to the use of tools and resources provided in support of service delivery. Liaison with vendor teams to assure relevance, accuracy and quality of knowledge management materials.
  • Deployment of and advocacy for new ways of working to HR Ops, HR Service Centre in consultation with Business HR and relevant CoEs to the benefit of the employee experience.
  • Applying knowledge of internal/external business challenges to provide input into recommendations for improvements to products, processes or services, continue to ensure the adoption of fundamental business drivers within the company.
  • Designing, developing and maintaining the project plans needed for the successful transition of services from newly acquired company to HR Ops/ HR Service Centre resources; leveraging the transition methodology and contributing to its continuous improvement through the application of lessons learned.
  • Identification and mitigation of risks to the project by the application of proven risk mitigation interventions and their active management.
  • Identification and tracking of issues as they arise and through the application of experience and judgement, their resolution/ appropriate escalation.
  • Process Development and Transition:
    • Focus on process optimisation to allow for transition of HR Services of newly acquired business.
    • Facilitate and lead process documentation, standardization, optimisation and design of key processes and systems for transition to existing HR Services team.
    • Involved with any process design, improvement and synchronisation within the HR business.
    • Ensure to use any templates, layouts and best practices across the region for all transitioned processes.
    • Ensure processes created are as robust and efficient as possible and fit within the HR portfolio.
    • Ensure along with the transition manager, that all projects are completed on time, within budget, and that all deliverables and requirements are met.
  • Knowledge Management:
  • Assure that customers, partners, and stakeholders are kept up-to-date with appropriate, timely, and relevant communication of trends, issues, and services, in partnership with country and regional change leads.
  • Assure proper documentation of HR services delivery agreements and procedures. Establish and communicate standards and protocols as necessary.
  • Process Improvement:
    • Diagnose process improvement opportunities and develop solutions using principles of process excellence and related tools.
    • Facilitate the implementation of processes optimisation across the organisation in the region.
    • Ability to identify process improvement opportunities and relay those opportunities to the relevant parties.
    • Document all process improvement opportunities so they can be successfully changed/managed.
    • Ability to identify opportunities for improvement and/or communication based on external market factors (including HR trends, industry, vendor markets and economic factors.)
  • Business Driver:
    • Change advocate, opinion shaper for the business HR organisation, evolving thinking and advancing our HR model.
    • Participate actively in any change/improvement discussions, contributing as per experience of any internal/external challenges with both captive and outsourced teams.
    • Have a clear understanding of the fundamental business drivers of the company and use this knowledge to the benefit outsourced team.
    • Assist with change strategy development and also the implementation into the organisation.
    • Assess and analyse the change impact.
    • Identify any anticipated resistance from the business.

 

Minimum Qualifications and Experience:

  • 3 – 5 years relevant experience.
  • Project Management.
  • Process Mapping.
  • MS Office Suite.
  • Workday experience desirable.
  • Visio experience desirable.

 

12209 – Project Manager Non-IT - Cork

Purpose:

The Project Manager will provide project execution support and expertise to a Vaccines manufacturing facility and other site colleagues to manufacture quality pharmaceutical products in accordance to meeting the company’s Priorities of: Compliance, Supply, Strategy and Profit Plan. The team working style is one of collaboration, coaching and facilitating to provide engineering solutions to the team to support a High-Performance Organization.

Responsibilities:

  • Responsible for project oversight and control activities, including, definition of scope, business case development, business requirements definition, milestone identification, project governance, operational planning, risk identification & mitigation, implementation planning, project execution oversight and project closure.
  • Responsible for ensuring that projects are delivery on time, to agreed level of quality and within approved budget.
  • Oversite & control for project cost management through the project life cycle.
  • Delivery of effective & accurate project progress reports that can be analysed and understood at all levels within the organisation.
  • Responsible for project stakeholder management to ensure effective delivery of project objectives – including escalation management.
  • Creation and control of project plans for departmental, cross departmental, and company-wide projects.
  • Responsible for project delivery risk and issue management, including the identification and implementation of risk and issue mitigating actions.
  • Motivate a multi-disciplinary team to achieve project objectives, through driving the team’s performance so that every individual understands their individual contribution and how it impacts the site.
  • Supporting other site project managers to develop standard reporting templates and KPIs.
  • Effectively communicating with and managing key stakeholders both internally and externally.
  • Proactively managing issues, proposing mitigation/response plans to resolve issues and effectively implementing the action plan.
  • Ensure there is a strong safety culture and performance in the execution of projects.
  • Lead teams providing on-going coaching and support to all team members, including the identification and development of key talent and skills within the site.
  • Sound financial stewardship, management and control.
  • Ensure highest Quality & Compliance standards. Participate and Comply with the company’s Quality Management System.

 

Minimum Qualifications and Experience:

  • Appropriate 3rd level or engineering trade qualification.
  • A minimum of eight to ten years of relevant experience in project delivery of a broad spectrum of projects in the Pharma industry preferably including experience managing and scheduling Supply Chain projects.
  • Knowledge of and experience in applying Lean Six Sigma and Lean methodologies and Engineering excellence through OEE, predictive maintenance planning.
  • Demonstrated leadership skills with a continuous improvement focus.
  • Desirable: evidence of Continuous Professional Development.
  • Project management qualification such as Project Management Professional etc.
  • Lead six sigma experience is essential, minimum yellow belt, preferable green belt.
  • Demonstrated ability in holding project team members responsible for results and being decisive about non-performers.
  • Demonstrated ability to realize improvement initiatives.
  • Demonstrated successes in a team environment, such as project teams, Six Sigma team, PITs etc.
  • Demonstrated high level of problem solving and facilitation skills.
  • Advanced PC skills such as Excel, Word, PowerPoint.
  • Experience with Management Systems such as PM, EHS, Trackwise, SAP , PRINCE, Microsoft PM etc.
  • Stakeholder management of multi decision makers, colleagues, peers and cross functional teams.
  • A proactive and intelligent individual who is quick to grasp new ideas and concepts and perform effectively under pressure and changing circumstances.
  • An excellent communicator and leader who is able to motivate themselves and others to meet stringent deadlines and rise to new challenges with enthusiasm.
  • Good decision-making skills on immediate issues to reach practical/acceptable solutions.
  • Influencing, negotiating and conflict management.
  • Individual who manages very well under pressure and proven workload prioritisation capabilities.
  • Understands the typical project life cycle from concept through to qualification in a strongly regulated GMP environments and has significant proven experience in this area.
  • Excellent interpersonal skills and an understanding of the customer/client relationship involved in project delivery.
  • Demonstrated leadership skills necessary to build and maintain high performance project management teams.
  • Excellent presentation skills

 

12210 - Project Manager Non-IT - Cork

Purpose:

The Program Manager will provide program and project management expertise to the site which manufactures quality pharmaceutical products in accordance with the company’s Manufacturing Division priorities of: Compliance, Supply, Strategy and Profit Plan. This Program Manager will ideally have a wide range of experience from several different programs and projects, spanning multiple disciplines and will have developed excellent people change management skills.

Responsibilities:

  • For program oversight and control activities, including definition of scope, business case development, milestone identification, governance, risk identification & mitigation, execution oversight and closure.
  • For the creation and control of schedule for departmental, cross departmental, and company-wide programs.
  • For ensuring that programs are delivered on time, to an agreed level of quality and within approved budget and scope.
  • For the delivery of effective & accurate progress reports & scorecards, that can be understood at all levels within the organization.
  • For stakeholder management, both internal and external, to ensure effective delivery of program objectives, including escalation management.
  • For identification of risks and issues and the implementation of mitigating actions.
  • For oversight & control of program cost management throughout the life cycle, and continually providing sound financial stewardship and control.
  • For motivating a multi-disciplinary Project Lead team to achieve program objectives, by driving performance so that everyone understands their contribution to the program and how it impacts the achievement of the site’s objectives.
  • For providing on-going coaching to Project Leads, including the identification and development of key talent and skills within the site.
  • For ensuring there is a strong safety culture and performance in the execution of programs and projects.
  • For ensuring the highest Quality & Compliance standards, participating and complying with the company’s Quality Management System.
  • Facilitating project and portfolio governance at the departmental level.
  • For supporting the development and running of the PMO on site.

 

Minimum Qualifications and Experience:

  • Appropriate 3rd level qualification.
  • Appropriate program/project management qualifications.
  • A minimum of eight to ten years of relevant experience in delivery of a broad range of programs, preferably in the pharmaceutical industry.
  • Knowledge of and experience in applying Program & Project Management tools & techniques with a wide spectrum of Project Leads and team members.
  • Demonstrated leadership & coaching skills, with an emphasis on continuous improvement of the PM process and skill sets of Project Leads.
  • Evidence of Continuous Professional Development, particularly in Program/Project Management and People Change Management.
  • Experience in site-wide strategic planning initiatives and supporting resulting programs and projects.
  • Excellent people and people change management skills.
  • Strong organizational and planning skills.
  • Excellent facilitation, communication and management of senior level stakeholders and other cross-functional leaders.
  • Strong leader who can motivate others to meet deadlines and rise to new challenges with enthusiasm. Demonstrated ability in holding Project Leads accountable for project delivery and being decisive about non-performers.
  • Strong influencing, negotiating and conflict management skills, with a good understanding of the customer/client relationship involved in project delivery.
  • Understands the typical program and project life cycles in a strongly regulated GMP environment and has significant proven experience in this area.
  • Demonstrated success in a program environment, such as multiple project teams, Six Sigma teams, PITs etc.
  • Demonstrated high-level problem-solving skills and the ability to realize improvement initiatives.
  • A proactive and intelligent individual who is quick to grasp new ideas and concepts and perform effectively under pressure and changing circumstances.
  • Good decision-making skills on immediate issues to reach practical/acceptable solutions.
  • Individual who manages very well under pressure and proven workload prioritisation capabilities.
  • Experience with Management Systems such as PM, EHS, Trackwise, SAP, PRINCE, Microsoft PM etc.
  • Advanced PC skills such as Excel, Word, PowerPoint.

 

12105 - Automation Engineer - IV - Tipperary

Purpose:

Specifically responsible for the PI Data Historian system and related Reporting. This candidate will be required to work closely with the MMDIT teams responsible for the full Automation and IT scope and with vendors / partners with responsibility for delivery of systems.

Responsibilities:

  • Develop and/or review System Development Life Cycle (SDLC) deliverables, compliant with MSD standards.
  • Work with Automation\IT team in development of systems architecture, specifications, controls strategies, sequence of operations through all design stages.
  • Ensure technical delivery of Data Historian and Reporting systems as endorsed by leadership team to meet business objectives.
  • Defining and delivering the project Data Historian and Reporting roadmap.
  • Responsible for regular communication to project leadership & multi-functional team stakeholders.
  • Provide input to schedule and budget development with MMDIT project lead.
  • Development of the Data Historian and Reporting team resources for the project and other supporting vendors.
  • Supporting development of the Data Historian and Reporting project execution plan, scope of work for the contract firms or specialists, and provide technical guidance during the execution of their work.
  • Participate in the development of digitization strategy for the project in alignment with the site digitization roadmap.
  • Required to comply with Global Policies, Procedures and Guidelines, regulatory requirements and execute current Good manufacturing Practices (cGMP) in the performance of day to day activities and all applicable job functions.

 

Minimum Qualifications and Experience:

  • Bachelor’s Degree in Engineering, Information Systems, Computer Science or the Life Sciences.
  • At least 8 years’ experience providing process control and information systems solutions.
  • Experience directing system design, configuration and application of business processes in a biopharmaceutical manufacturing environment.
  • Project delivery and operations support experiences of Data Historian and Reporting systems.
  • Working knowledge of one or all the following systems is essential; OSI-PI, PI-AF, RT Reports, Kepware, FactoryTalk.
  • Experience with process control systems would also be advantageous.
  • Designing of information interfaces, data conversion, and network and infrastructure fundamentals.
  • Ability to anticipate, evaluate and resolve multiple, simultaneous project issues, delays and problems by utilising technical, project management, and business expertise.
  • Ability to translate strategic opportunities and emerging technology solutions into tangible pragmatic executable plans.
  • Working knowledge of GAMP software development lifecycle, ANSI/ISA-S88 and S95 industry standards.
  • Thorough knowledge of Pharmaceutical Industry Regulations (cGMP/cGLP, OSHA, EPA/EQB) required.

 

 

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11112209 - Packaging Operations Associate - Dublin

Responsibilities:

  • Ensure all training on equipment, processes, and facility and safety procedures are maintained and up to date at all times.
  • Perform day-to-day manufacturing and cleaning activities to meet schedules while maintaining a high level of GMP compliance.
  • To aid with troubleshooting and resolving operational problems during packaging.
  • Ensure all documentation is completed to the required standard and within the specified timelines.
  • Review batch records and other manufacturing process records as required.
  • Routinely draft and revise standard operating procedures and master batch records.
  • To aid in deviation investigations and closures.
  • Support continuous improvement initiatives by identifying areas needing improvement, recommending strategies for improvement, and implementing those strategies once approved.
  • Maintain a high, and continuously improving, level of GMP compliance to ensure patient safety and to minimize risk to the company business.
  • Support Regulatory licensure activities, including agency inspections.
  • Report to Area Supervisor on a regular basis on line performance and report any issues that need to be resolved.
  • To train and be cross functional across all manufacturing areas of the packaging and warehouse facility.
  • To perform any other task or duties as assigned by Area Supervisor.

 

Minimum Qualifications and Experience:

  • Third Level qualification in a scientific or engineering discipline or equivalent experience would be desirable.
  • 2-5 years’ experience in Packaging Operations in a GMP environment.
  • Must be able to work within and adapt to complex electronic systems such as SAP.
  • Experience with warehouse equipment and systems preferred.
  • Should be knowledgeable of regulatory and GMP requirements.

 

12063 – QC Specialist (Glims) - Cork

Purpose:

The stability quality specialist will provide Quality support and expertise to the laboratories and ensure supply of quality pharmaceutical products in meeting the company priorities of: Compliance, Supply, Strategy and Profit plan. The team working style is one of collaboration, coaching and facilitating to provide Quality oversight and expertise to the laboratory team to support a High Performing Organisation.

Responsibilities:

  • Deliver a robust Quality Management System to support a flexible, collaborate, multi-skilled teamwork environment.
  • Update LIMs for all changes and addition of new products.
  • Ensure that LIMs is maintained and streamlined were possible.
  • Coordinate and communicate the prioritisation of updates and changes in LIMS to all impacted users.
  • Complete training as required with LIMs users.
  • Support the review & approval of key quality deliverables including LIMS, Change control, trackwise, Deviations, CAPAs. Etc.
  • Review & approval of GMP procedures (& associated documents) for the lab
  • Participation in inspection of site by CQAC/Regulatory Bodies /third parties.
  • Champion the highest quality and compliance standards for the laboratories.
  • Makes decisions within guidelines and policies which impact QC projects.
  • Champion the highest Quality and Compliance standards for QC labs.

 

Minimum Qualifications and Experience:

  • Degree in IT and/or Science, Quality.
  • At least 3-5 years’ experience in the Pharmaceutical industry or a similar operating environment, with a strong emphasis on QC systems, in particular LIMS.
  • Knowledge on software
  • Good analytical and technical skills.
  • Demonstrated change management skills (CEM) with continuous improvement.
  • Demonstrated use of Leadership Behaviours.
  • Knowledge and experience in interpreting current applicable regulatory requirements and providing independent Instrumentation and validation to the site.
  • Demonstrated ability to work independently and fully realize improvement initiatives with minimal guidance.
  • Demonstrated ability to drive the completion of tasks.
  • Stakeholder management of multiple decision makers, auditors, cross functional teams by demonstrating the ability to maintain and strengthen trust relationships with people on all levels.
  • Proven decision-making capability with full accountability and responsibility
  • Desired:
  • Evidence of Continuous Professional Development.
  • Evidence of continuous Professional development.
  • Preference for lean Six Sigma Yellow Belt.

 

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10643 – Project Manager Non-IT – Carlow & Cork

Purpose:

Reporting to the Suite Team Lead, as part of a multi-discipline team, specifically responsible for assisting the lead in the cost and schedule aspects of the Suite scope. This candidate will be required to work closely with a cross-functional team and coordinate activities between Design, Construction, Process, Technical Operations, C&Q, IPT and QA.

Responsibilities:

  • Reporting to Suite Team Lead.
  • Assist in the development, within the overall project schedule, of a schedule for the delivery of all aspects of the Suite scope.
  • Provide support for the administration, within a project charter, of the Suite project execution within the overall capital project budget and schedule.
  • Develop, document, agree and implement an execution strategy to deliver the scope in a controlled and well communicated manner.
  • Coordinate the design effort with the contract engineering firm and ensure compliance to local & Global Standards.
  • Facilitate engineering and user requirements for the black utility systems.
  • Facilitate project job specification processes with A/E and end user.
  • Develop or contribute to the pertinent Mechanical/HVAC/Utility narratives for the project Design Manual and subsequent Design Reports.
  • Coordinate review of design material from the owner’s side including Layout reviews, P&ID/AF&ID reviews, Process Descriptions, Job Specifications, and PO’s/Data Sheets.
  • Coordinate, along with procurement, vendor qualification/selection for major equipment and packaged equipment.
  • Assist in the assurance that project utilities designs are safe, constructible, operable, maintainable, economical, and compliant with regulatory requirements and authorized project scope.
  • Participate in Value Engineering.
  • Attend FATs when appropriate.
  • Review C&Q plans/protocols as related to Suite systems.
  • Provide coordination expertise during C&Q activities as needed.
  • Assist in the coordination of C&Q start-up activities, punch list follow-up.
  • Liaise with the various stakeholders on the overall project to ensure clear communication between all parties.
  • Facilitate/expedite Mechanical Completion in conjunction with the Construction team.
  • Liaise with construction contractors towards successful completion of Construction Turn Over Documentation.
  • Coordinate third party vendors during SAT execution. Review and contribute to SAT protocols.
  • Lead and attend daily communication meetings, as appropriate, with suite teams and report progress.
  • Assist in investigations of process equipment, utility systems, and control system anomalies, as well as safety incidents.
  • Maintain a clean and safe working environment by enforcing procedures, policies, and regulations.
  • Safety of all suite team members for the duration of the design, construct, commission validate and handover of the suite scope.
  • Support of the Suite Leads in clear, and documented, definition of scope and scope boundaries.
  • Delivery of the agreed milestones on the schedule within budget constraints.
  • Delivery of stakeholder agreed scope for Suite facilities to Commissioning Qualification or as appropriate Process Qualifications.

 

Minimum Qualifications and Experience:

  • Bachelor of Engineering or Science Degree in Engineering or Technology related discipline.
  • Minimum of 4-6 years’ experience similar role in Pharmaceutical Process/ Building/Utilities systems within Pharmaceutical industry.
  • Working knowledge of standards as they apply in biotechnology processes industries and a working knowledge of FDA and EU regulations is preferred.
  • The candidate will be a convincing communicator with strong interpersonal skills.
  • Experience of design and or construction/handover of pharmaceutical process and/or building facilities for pharmaceutical facilities.
  • Ability to work in design and construction large project environment within Ireland.
  • Strong interpersonal and communication skills (verbal/written.)
  • Working knowledge of control systems and automation.
  • Working knowledge of C&Q documentation required for cGMP project delivery.
  • Fluent in English, written and verbal.
  • Ability to generate and communicate project plans and schedules.
  • Working knowledge of word processing, spreadsheets, database management software, CAD software, and PCs.

 

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12203 – Financial Analyst - Remote - Available To Travel Within Ireland

Purpose:

The role forms part of an All-Ireland Accounting to Report supporting several entities under a standardized global framework. This team operates virtually across Ireland servicing entities in Cork, Tipperary, Carlow, Dublin and now Meath. This role will be predominately remote but will require occasional travel within Ireland.

Responsibilities:

  • Core Accounting:
    • Execute in-country ATR activities / processes (including US GAAP / local reporting,) and perform period end adjustments to support the closing process for any of the entities under the All-Ireland remit but specifically the new Dunboyne site.
    • Liaise with Centers of Excellence in the delivery of their services.
    • Mapping and reconciliation of financial transactions and service fees associated with the TSA.
    • Support the Tax and treasury team in the transactions required to support the integration.
    • Liaise with the Global / Regional ATR teams to support transactional activities and record entries into the ERP system, while ensuring compliance with all quality / control requirements.
    • Support balance sheet account reconciliations within the Blackline framework and follow-up of open items.
  • Audit & Control Environment:
    • Work with internal and external auditors on providing the requested schedules/information and coordinate the follow-up of outstanding questions/queries.
    • Coordinate MCAAS / PwC virtual audits covering Sox, US GAAP/Group, Statutory and Business Integrity audits across the GHH, MAH, company entities in scope.
  • Process Improvement & Issue Resolution:
    • Support system and business process change management associated with the integration.
    • Partner with ATR process owners to support and enable change efforts to drive continuous improvement.
    • Support Finance Leadership with process improvement, policy development, and / or strategic initiatives (e.g., business systems, processes, and / or policies.)

 

Minimum Qualifications and Experience:

  • Proven experience in General Accounting, Tax Reporting and Month End Close Processes.
  • 7 Years PQE, from a multi-national company within a regulated industry.
  • Hands-on knowledge of SAP/Blackline is desirable.
  • Hands on experience in a Sox compliant controls environment.
  • Microsoft Excel and other Microsoft applications.
  • Ability to deal with ambiguity and work on own initiative.
  • Work with virtual teams as well as the ability to influence without authority.

 

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12200 - Process Engineer - Carlow

Purpose:

New exciting opportunities now exist on our Carlow Site for a Project Engineers within our Carlow Project Engineering Group (CPEG), part of the larger Technical Engineering Department. Reporting to the Associate Director Technical Engineering (CPEG) as Project Engineer you will lead and manage multiple Technical Engineering projects from scope development, design, build/install and qualify through to handover to operations for key Technical Engineering projects at Carlow. This includes but is not limited to: Process improvements, capital projects and Lean projects across multi-disciplined functions which may also require global and network support and collaboration. The suitable person will typically have prior related work project engineering experience; ideally in manufacturing, preferably GMP Setting with process engineering and/or validation experience in a sterile manufacturing environment and have a proven track record in leading a technical team of engineers / scientists through sustaining operations and technical transfer projects but we will consider applicants from other working environments. Our Engineers support internal and external manufacturing operations remain operational, continuously improve and innovate. With our extensive range of facilities and environments, our Engineers have opportunities across many diverse areas including Biological, Chemical, Automation, Capital Projects, Maintenance, Safety, Process Development, Technical Services, Utilities and Validation.

Responsibilities:

  • Manage projects at Carlow from scope development, design, build/install and qualify through to handover to operations for key Technical Engineering projects at Carlow.
  • Use scientific, product and process understanding as a basis for developing risk-based approaches to investigations and troubleshooting that will feed into future projects.
  • Develop project scope, cost and delivery time schedule for all Tech Eng projects, working and collaborating closely with Technical engineering leads to ensure integration into ongoing.
  • Validations and/or Technical transfers.
  • Collaborating closely with cross functional teams to establish scope in improvement projects at Carlow as we ramp up to a fully commercial site.
  • Act as a subject matter expert on: equipment design and qualification; assisting in C&Q execution planning; system boundary definition, system level and component criticality impact assessments, use of quality risk management, User Requirement Specs. And requirements traceability matrices.
  • Document Mgt. Systems, FAT/SAT and C&Q protocol development, project implementation.
  • Sponsor and foster lean six sigma and standard work within the technical engineering Team (e.g. Structured Root Cause Analysis, Statistical Process Control, Data driven decision making)
  • Drive and support continuous improvement by active participation in projects, system failure investigations and investigation reports, execution/development of change control, and contribution to Kaizen events as appropriate.
  • Perform root cause analysis of system failures, substandard performance, using standard tools and methods, to resolve machine and system issues e.g. FMEA, Fishbone diagrams, 5 why’s etc.; implement subsequent corrective action through the change management system Integration of Computer Systems Validation activities, in collaboration with Automation/IT partners, into required projects.
  • Drive collaboration between groups within the Technical Engineering function proactively looking for synergies and innovative ways of doing work. Constantly assessing our systems and processes to see what improvement we can make to work smarter and more efficiently while all the time being compliant.
  • Act as a liaison with both global engineering services and facilities as well as specialist vendors to deliver projects on time and in full as required by the business.
  • Required to comply with Global Policies, Procedures and Guidelines, regulatory requirements and execute current Good manufacturing Practices (cGMP) in the performance of day to day activities and all applicable job functions, ensuring consideration of the impact on GMP and compliance and decisions made.
  • Accountable for compliance via documentation completion, risk assessments, closing out corrective action, participate in audits and inspections and proactively highlighting any issues around compliance.
  • Work collaboratively to drive a safe and compliant culture in Carlow. Collaborate with multiple partners (eg. Company network groups, third parties, vendors, quality, donor sites, Supply chain, IPT) in achieving excellence in technical transfer programmes.
  • Serve as technical engineering representative for internal technical group discussions and represent Technical Engineering Carlow at Global Technical Forums as required.
  • May be required to perform other duties as assigned.

 

Minimum Qualifications and Experience:

  • Bachelor Degree or higher preferred; ideally in a Science, Engineering or Other Technical discipline.
  • Considerable experience in a comparable role; would typically have experience operating as a senior professional and adding considerable value to the business.
  • Would have process engineering and/or validation experience in a sterile manufacturing environment and have a proven track record in leading a technical team of engineers / scientists through sustaining operations and technical transfer projects.
  • Experience in leading through change would be an advantage.
  • Knowledge of regulatory/code requirements to Irish, European and International.
  • Codes, Standards and Practices.
  • In depth knowledge and experience of Sterile filling processes and equipment especially aseptic processing.
  • Experience of executing and/or managing through equipment and process design and validation in a sterile environment.
  • Good shipping/Filter/Cleaning validation knowledge required.
  • Knowledge of QbD/CPV desirable.
  • Excellent report, standards, policy writing skills required.
  • Automation and MES knowledge.
  • Proficiency in Microsoft Office and job-related computer applications required.
  • Lean Six Sigma Methodology experience desired.
  • Experience in audit preparation and execution desired.
  • Having a strong safety ethos.
  • Have proven record of process improvement implementation.
  • Have a proven record of project management of change in a commercial site.
  • Excellent people management skills.
  • Proven record in planning and basic project management of a team to deliver on time/schedule and cost.
  • Proven contractor and vendor management.
  • Excellent facilitation and assessment skills.
  • Have shown the ability to manage budgets and forecasts and use a formal capital management process.

 

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12185 - HR Analyst - Dublin

Responsibilities:

  • Works with business leaders to champion a high-performance culture and to create an environment of trust, dignity and respect, where behaviours are aligned to the Company values.
  • Supports organisational change projects and their associated people implications.
  • As part of the company’s Manufacturing Division, participates in the development of the company’s strategy within Biotech and long-term business development plan.
  • Work with client leaders to support delivery of their people strategy.
  • Facilitates talent/performance management and succession planning across client groups, aligned to global processes.
  • Provides effective coaching for leaders through handling of complex employee relations issues.
  • As part of the Ireland HR team, support and lead projects across the country that support our HR priorities.

 

Minimum Qualifications and Experience:

  • Bachelor’s degree; CIPD qualification or relevant master’s degree.
  • 3-5+ years’ experience in an HR role, ideally with experience of working in a HR Business Partner model, but all HR disciplines will be considered.
  • Experience working in a large multi-national manufacturing environment would be ideal, but background is less important than outlook.
  • Proven track record of HR delivery, either in a COE role or HRBP.
  • Strong knowledge of Irish and European employment law framework.
  • Effective at coaching and managing multiple stakeholders.
  • Highly effective communicator with the ability to influence outcomes at all levels of the business.
  • Ability to project manage multiple projects and initiatives through to successful delivery.
  • Ability to build trusted partnerships and to work effectively with people at all levels.

 

 

11105669 - Engineering Systems Administrator - Dublin

Purpose:

The Engineering Systems Administrator is responsible for the operation and administration of the site Computerised Maintenance and Calibration System on the Site. This position is responsible for all Infor (CMMS) Activities, maintenance of all Maintenance & Calibration Data.

Responsibilities:

  • Maintaining the Computerised Maintenance Management System by adherence to all relevant SOP’s, policies and cGMP requirements.
  • Act as a subject matter expert for the site CMMS, Infor EAM.
  • Issue and maintain key performance metrics for the Engineering department.
  • Input all scheduled and unscheduled maintenance and calibration tasks in accordance with site policies and procedures.
  • Proactively ensuring that all Environmental, Health and Safety responsibilities are carried out according to EHS regulations and procedures.
  • Ensure the CMMS is maintained correctly, verification of all data entered.
  • Creation of all Equipment & Instrument Assets (Criticality Assessments / Tag Number Creation / Generation of PM & Calibration Routines.)
  • Processing / Generation of all Planned Maintenance & Calibration Activities on a Monthly Basis.
  • Development of key Reliability Metrics (KPI’s.)
  • Document Control of all related forms for Maintenance & Calibration Activities.
  • Provide support to Operations, Validation, Engineering and Quality where required.
  • Oversight of all Data Build Project Activities (Including support resources.)
  • Attend Weekly Scheduled Meetings for all CMMS Related activities.
  • Other duties as required.

 

Minimum Qualifications and Experience:

  • Degree / Diploma in Science / Engineering.
  • Min 2-3 years, exposure in Maintenance, Facilities or General Engineering environment.
  • Knowledge / Exposure to Calibration & Maintenance Activities.
  • Problem Solving skills – demonstrated ability in the use of scientific methodology to problem solve.
  • 2-4 years’ experience working within a facilities, maintenance and calibration environment in a cGMP commercial manufacturing environment.
  • Prior experience with CMMS and Computerised Calibration Systems.
  • Good interpersonal, communication and problem-solving skills.
  • Must be knowledgeable of the regulatory and GMP requirements for maintenance activities, Instrumentation and Calibration.

 

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Pharmacists - Various Locations

We are currently recruiting for Pharmacists for a number of vacancies across the country (Dublin, Tipperary, Limerick, Cork, Longford, Portlaoise)
All levels – Relief, Support, Supervising and Supervising Pharmacy Manager
Permanent full time positions
For more information contact us today

 

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12170 – Process Technical Specialist - Cork

Purpose:

The role involves providing technical & equipment support to the Vaccines Integrated Process Team (IPT). You will ensure on-going optimization of the process and manufacturing support to ensure the continued manufacture and supply of quality pharmaceutical products in meeting our Manufacturing Division Priorities of: Compliance, Supply, Strategy and Profit Plan. As a Process Technical Specialist you will work with the IPT team to ensure the effective and efficient on-time delivery of batch production within the IPT area. This requires the delivery of process excellence and reliability across all areas of the IPT.

Responsibilities:

  • Lead and participate in problem solving teams across all areas of the IPT (e.g. reliability, Safety, Quality (e.g.CAPA/DN/MDNs etc.)
  • Lead and close process related deviations and reports.
  • Support Operations team to consistently deliver on specific area Key Performance Indicators (KPIs), e.g. EHS metrics, Production Plan, OEE, compliance and team training.
  • Provides frontline technical EHS support & coaching to the operational team and be first point of contact for safety related concerns (e.g. Entropy actions/MOC/Permits/Risk assessments.)
  • Protocol/report authoring/execution/oversight/approval as appropriate.
  • Ensure highest Quality, Compliance and Safety standards.
  • Participate and comply with the company’s Manufacturing Division Quality Management Systems (QMS) requirements, including ownership, as relevant.
  • Provide ongoing coaching and support to cross functional team members, to share process, engineering and maintenance best practices.
  • Provide coaching and development to all technicians within the IPT.
  • Tactical Implementation & Support for reliability equipment initiatives.
  • Ensure supply of high quality product through ensuring equipment availability; maximize team member performance through continuous process improvement initiatives.
  • Provide technical, process and engineering expertise within a wide range of projects within the IPT, such as the introduction of new equipment and process’.
  • Author/approve Change controls and MIDAS documents as appropriate.

 

Minimum Qualifications and Experience:

  • Level 8 honors degree in a science or engineering discipline.
  • 3-5 years Engineering/Technical experience within a GMP Environment preferred.
  • 3-5 years’ experience in a highly regulated manufacturing environment in a technical or manufacturing support role.
  • Knowledge of and experience in applying Lean Six Sigma and Lean methodologies, with an understanding of regulatory and validation requirements.
  • Lean Six Sigma Green Belt desirable.
  • Demonstrated successes in a team environment, such as project teams, Lean Six Sigma team, etc.
  • Demonstrated problem solving capabilities.
  • Ability to interact with multiple stakeholders.
  • This role may require you to work shift.

 

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21309 - Senior Process Scientist – Purification - Limerick

Purpose:

Supports the Process Sciences Department through small scale laboratory experiments, as well as analysis, troubleshooting, and validation of manufacturing bioprocesses.

Responsibilities:

  • Provides technical support for Technology transfer purification activities.
  • Performs purification investigations in the laboratory and creates associated reports.
  • Develops and writes responses for technical sections of Regulatory documents.
  • Conducts scaled-down production procedures to improve the efficiency and yield of candidate or existing bioprocesses.
  • Develops and writes protocols for small-scale process validation studies.
  • Carries out small-scale purification process validation studies.
  • Assists in the analysis of samples generated from lab scale studies.
  • Tabulates results and writes summary reports of process evaluation and validation studies.
  • Presents findings at group and possibly at interdepartmental meetings.
  • Maintains lab supplies and equipment.
  • Produces and maintains accurate records.
  • Provides coaching and mentoring to junior members of the team.

 

Minimum Qualifications and Experience:

  • PhD in Biotechnology, Biochemistry, Chemical Engineering or a related field with 3+ years’ experience.
  • May consider another discipline with added relevant experience or an MSc Biotechnology or related field with 6+ years relevant experience.
  • Experience in a biopharmaceutical setting is desirable.

 

 

2020-336 – Supply Chain Team Lead - Waterford

Purpose:

To lead and support the Supply Chain Specialists team activities for both clinical and commercial product from multiple manufacturing and packing sites and to ensure products are delivered on time and in full.

Responsibilities:

    • Lead, coach and support team with related Order management and planning activities:
      • Managing and analysing and actioning customer forecast data.
      • Sales Order management.
      • Interpreting MRP output data with respect to production schedule, plant capacities and purchasing requirements for clinical and commercial products
      • Analysing product performance and plant capacity data across multiple sites and performing mathematical calculations to determine unit operations and human resource requirements.
      • Managing Artwork approval process.
      • Monitoring production schedules, expediting operations that delay schedules and altering the schedules to meet unforeseen conditions.
      • Making sure product delivery dates are met as agreed with the customer.
      • Preparing campaign readiness trackers.
      • Communicate production schedules for multiple sites to the key stake holders.
    • Lead, coach and support team with related purchasing activities:
      • Analysing and interpreting bills of material, vendor specifications, etc, to ensure materials are supplied and delivered to GMP or equivalent standards.
      • Analysing the Purchasing Requisitions generated from MRP and recommend approval.
      • Monitoring supplier performance and taking corrective actions as required.
      • Monitoring and analysing stock reports for multiple sites.
      • Negotiate price changes and other terms and conditions with suppliers to obtain the best return at the most cost-effective prices possible while retaining quality specifications.
      • Providing forecast data to key suppliers.
    • Lead, coach and support team in relation to all areas of compliance:
      • To ensure that all work carried out is in compliance with the required standards conforming to company, cGxP, SOPs, regulatory regulations and guidelines, safety and environmental guidelines.
      • Ensure high quality output – vigilantly watch over job processes, tasks and work products to ensure freedom from errors, omissions or defects.
      • Initiate action to correct quality/schedule problem or notify others of quality issues as appropriate. If a procedure does not exist, devise one, (through the appropriate channels); if a process needs amending, do so through the appropriate channels.
    • Continuous Improvement:
      • To develop a culture of continuous improvement within the team, leading to the identification and implementation of improvements being part of normal standard work.
      • To develop a culture of cross functional continuous improvement through working with other Team Leads to maximise efficiencies and remove Non-Value Add activities where possible.
    • Tiered Accountability:
      • Lead related Tiered accountability meetings effectively to ensure action ownership, accountability and commitments are clear and understood.
      • Actively engage and participate in all required Tiered Accountability meetings.
    • Leadership Standardised Work:
      • Lead Weekly Supply Review Meeting focusing on key Supply Chain performance indicators and identifying related actions required.
      • Lead Weekly Planning meeting to ensure all stakeholders are agreed on current plan and on rough cut plan looking out for full demand horizon.
      • Introduce Coaching / Mentoring and support of team members as part of standard work helping with problem solving and skill development to aid learning and early problem resolution.
    • Documentation:
      • Ensure all planning and purchasing procedures are fully documented.
      • Ensure all related documentation is completed correctly.
    • Recruitment:
      • Recruitment – assist with recruitment of team members in line with resource requirements and to job spec.
      • To perform additional team tasks as agreed to support effective running of the Business.
    • Health & Safety:
      • Ensure requirements of the company’s Safety Statement are implemented.
      • Continuously promote a positive safety culture by leading by example.
      • Implement safety requirements as per site documentation including SOP’s, Safety Statement and COP’s.
      • Report any observed unsafe conditions or behaviours.

 

Minimum Qualifications and Experience:

  • Qualified to a minimum of degree level or equivalent work experience.
  • At least 3 years’ experience leading a planning and/or purchasing team.
  • Must have advanced experience with SAP.
  • Project management skills.
  • Experience within the pharmaceutical sector or similarly regulated industry would be of benefit.

 

21370 – Project Manager QC Support - Limerick

Purpose:

Using strong project management skills and knowledge of QC lab activities, the QC Project Manager is responsible for project managing the implementation of QC initiatives. The PM collaborates with cross-functional departments as well as external vendors to plan, manage and drive project activities within agreed quality, scope, budget and time. Builds and maintains productive relationships with a wide variety of internal and external stakeholders. Ensures superior quality and timeliness of project deliverables.

Responsibilities:

  • Leads and manages the planning and execution of QC deliverables for the QC Laboratory electronic systems implementation projects within project timelines and in compliance with GMP/GLP.
  • Leads cross-functional teams and manages the planning and execution of deliverables for assigned QC projects.
  • Acts as single point of contact for assigned project related communications with internal project leads and external stakeholders.
  • Leads projects and prioritizes using excellent organizational, communication, project management and time management skills.
  • Leads a QC program team with shared resources in a matrix style organization; capable of mentoring and managing team members through influence rather than direct authority; ensures delegation to appropriate team members based on expertise.
  • Ensures teams and stakeholders are aligned on one single project plan. Plans and tracks the project activities.
  • Facilitates regular project focused meetings with external stakeholders and working teams (budget and procurement, qualification, validation, regulatory, facilities & engineering, lab automation, LIMS, IT, QC Tech Resources and AS, etc.).
  • Coordinates contingency and risk mitigation planning for projects.
  • Ensures meeting notes are completed accurately and follows up on action items.
  • May oversee a team of Project Coordinators who assist in managing sub-teams.
  • Regularly interacts with Sr. Management or executive levels. Exercises judgment and exerts some influence on the overall objectives and long-range goals of the QC Department. Represents the department in relevant internal/external committees.
  • Lead special projects as assigned by supervisor/department management.

 

Minimum Qualifications and Experience:

  • BA/BS in chemistry, biology or related field.
  • 7+ years of relevant experience, preferably in the pharmaceutical or biotechnology industries.
  • Previous Project Management experience and/or PMP certification is considered a plus.
  • Working knowledge or exposure to software used in the laboratory environment (LIMS, ELN, Empower.)
  • Requires excellent written, verbal and interpersonal communication skills and the ability to effectively interact with all levels both within and outside the company.
  • Resolves and negotiates conflicts or problems with tact, diplomacy and composure.
  • Ability to handle multiple projects and priorities with exceptional organizational and time management skills.

 

21316 – QC Associate Manager - Limerick

Purpose:

Oversees the laboratory quality control testing of in-process, stability, and final drug products. Has technical responsibility for all bioanalytical aspects of QC testing.

Responsibilities:

  • Coordinates with members of Manufacturing, Stability, and Business Ops to provide analytical support.
  • Manages QC Analysts, distributes work load, and monitors progress.
  • Manages product testing to ensure efficient and compliant operations.
  • Reviews test reports.
  • Ensures QC Analysts receive proper training.
  • Attends meetings to keep informed of manufacturing priorities.
  • Ensures that safety standards are maintained.
  • Ensures compliance with applicable cGMP regulations and SOPs.
  • Investigates atypical and OOS test results as necessary.
  • Manage assay transfer internally from R&D to the QC laboratory or from PAS to the QC Laboratory.
  • Manage assay transfer externally from QC laboratory to contract labs, includes audits if needed.
  • Manages QC projects including analytical commitments for Regulatory filing, follow-up actions for general GMP inspections and its readiness.
  • Track and coordinate major analytical investigation
  • Track and monitor timeline of analytical validation projects.
  • Monitor the team performance for Compliance events, track, assist and organize continuous improvement events.
  • Interact with Regulatory Agencies as needed to ensure cGMP compliance.
  • Special projects as assigned.
  • Performs personnel management functions including time sheet submissions, scheduling of vacations, personnel development/feedback, and performance evaluations.

 

Minimum Qualifications and Experience:

  • Requires BS/BA in Life Sciences or related field.
  • 6+ years of relevant experience, preferably in the pharmaceutical or biotechnology industry. Previous supervisory/ leadership experience in a laboratory environment is required.
  • Thorough understanding of bioanalytical techniques in a cGMP environment.

 

21439 – QC Manager – Technical Resources - Limerick

Purpose:

Perform, review and manage assay development, characterization, optimization, transfer, validation and investigation for QC chemistry or QC Biochemistry group. Provide technical support, guidance and supervision for release, stability, and in-process testing and assay development.

Responsibilities:

  • Perform, review and manage assay development/validation for QC Chemistry or QC Biochemistry group.
  • Review new test procedures and assays.
  • May evaluate and bring in new methodologies/techniques when needed.
  • Facilitate assay transfer from R&D and to business partners.
  • Organize analytical assay transfer internally and externally.
  • Participate in technical troubleshooting and problem investigation.
  • Review analytical development report, assay and process validation report and other technical documents for technical correctness and regulatory compliance.
  • Participate in training programs for analysts.
  • Performs personnel management functions including time sheet approvals, scheduling of vacations, employee development, and employee evaluations.
  • Monitors day-to-day method performance in QC lab and identifies appropriate subject matter expert to help any method related issues.

 

Minimum Qualifications and Experience:

  • Requires BS/BA or AAS in Life Sciences or related field
  • 7 years of experience working in a GMP lab including 2+ years of management experience, or:
  • MS plus 4 years GMP experience including 2+ years management experience, or:
  • D. with 2 years of GMP experience including 1+ years of management experience.
  • Level will be determined based on experience.

 

21119 – Supervisor Biotech Production – Upstream (Cell Culture) - Limerick

Purpose:

Supervises the implementation of commercial manufacturing production schedules. Supervises the manufacturing shift team in relation to process execution for Upstream and/or Downstream processes.

Responsibilities:

  • Supervises commercial scale manufacturing of recombinant proteins according to approved protocols, regulation, and schedule.
  • Supervises a team responsible for the manufacture of bulk drug substance in a cGMP regulatory environment.
  • Ensures that the highest safety and housekeeping standards are maintained.
  • Supervises all aspects of respective areas of operations. Ensure there is effective process oversight at all times.
  • Reviews and edits batch records in accordance with cGMP standards.
  • Ensures availability of production batch records for upcoming lots.
  • Schedules shift duties and batch tasks based on master production schedule.
  • Ensures equipment readiness and coordinates regular equipment maintenance and calibrations; troubleshoots equipment.
  • Performs cGMP audits of production area.
  • Performs people management duties including time sheet submissions, scheduling of vacations, personnel development, disciplinary actions, hiring and performance evaluations.
  • Critical to the development of the leadership skills of their team leads.
  • Schedules individual and ongoing training.
  • Interfaces with other departments, such as Facilities, Process Development, Process Analytical Sciences, Regulatory, Quality Assurance, Validation and Quality Control.

 

Minimum Qualifications and Experience:

  • Requires a 3rd Level Qualification in Life Sciences with 5+ years of relevant experience in manufacturing within the Biopharma industry.
  • Previous supervisory experience a distinct advantage.
  • Knowledge of cGMP and ICH guidelines.
  • Experience supervising shift organisations in the past would be a distinct advantage.
  • Strong knowledge of recombinant protein manufacturing techniques and methods, which include bioreactor culture and harvesting, liquid solution preparations, and purification and formulation of recombinant protein.
  • Excellent knowledge of Microsoft applications such as Excel, Word and PowerPoint. Excellent interpersonal, written, and oral communication skills.
  • Strong understanding of both regulatory and quality requirements and how such impacts decisions.
  • Strong decision-making skills.
  • Able to build trust and respect as a supervisor of people, with a priority for the development of staff.

 

20135 – Associate Manager QC Microbiology - Limerick

Purpose:

Manages the QC Microbiology team and provides critical microbiology support to manufacturing and facilities.

Responsibilities:

  • Manage a team of laboratory analysts within the QC microbiology department involved in the analysis of raw materials, intermediates (in process) and bulk drug substance in a cGMP regulatory environment.
  • Implement and manage the environmental monitoring programme, including surface, settling and viable and non-viable particulate air monitoring of aseptic operations and controlled areas
  • Responsible for all QC microbiological aspects of cGMP compliance and sample analysis.
  • Design and oversee microbiological validations as needed for drug substance, in-process controls and buffers.
  • Manage the design, validation and execution of the clean utilities qualification and re-qualification program.
  • Support manufacturing personnel in the identification of microbiological root cause analysis and provide technical advice on QC related topics as needed.
  • Participate in the investigation and review of alert and action limit investigations as needed and implements corrective action as appropriate.
  • Ensure that all work carried out is in compliance with the required regulatory standards, conforms to company policies and standard operating procedures (SOPs.)
  • Review and approve method protocols, reports and SOPs.
  • Assist in the preparation for internal/customer/regulatory inspections.
  • Ensure a safe working environment within the laboratory.
  • Proactively identify and implement lab process improvements, lean initiatives.
  • Oversee or conduct laboratory investigations and generates reports in response to invalid assays, Deviations, OOS/OOT.
  • Ensure that CAPAs and Change Controls are initiated and completed on time and in accordance with site procedures.
  • Present analytical data reports clearly and concisely to senior management, including QC performance metrics and trends.
  • Ability to train, develop and mentor direct reports and effectively manage the performance of individuals.

 

Minimum Qualifications and Experience:

  • BS/BA in Microbiology or closely related field.
  • 6+ years’ experience in microbiology lab, preferably in the pharmaceutical or biotech industry with 3+ years’ experience in a leadership role in microbiology laboratory management.

 

20713 – Process Scientist – Process Validation - Limerick

Purpose:

Supports the Manufacturing Support Process Sciences Department with analysis, troubleshooting, and Process Validation of manufacturing bioprocesses.

Responsibilities:

  • Supports all Process Validation activities.
  • Defines Process Validation Strategies.
  • Authors, reviews and approves Process Validation protocols and reports.
  • Schedules and supports Process Validation executions.
  • High level of technical and scientific writing required.
  • Present Process Validation documents at regulatory audits.
  • Technical and Scientific understanding of cell culture and downstream operations for process validation.
  • Performs scientific process investigations with relevant departments as required.
  • Provides process validation support for Manufacturing operations.
  • Participates in or leads process FMEAs.
  • Presents findings at group and at interdepartmental meetings.
  • Communicates information on current process data which may impact Process Validation.

 

Minimum Qualifications and Experience:

  • PhD in Biotechnology, Biochemistry, or a related field with 0-2 years’ experience; may consider another discipline with added relevant experience.
  • Candidates with an MSc in Biotechnology or a related field with 3+ year’s relevant experience will also be considered.
  • cGMP experience is desirable.
  • Relevant Quality Assurance and/or validation experience is desirable.

 

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21071 – Manager Manufacturing Technical Operations - Upstream - Limerick

Purpose:

Mgr/ Sr Mgr role, key member of the operations management team at Raheen. Provides technical management and support to ensure key deliverables of the manufacturing department are achieved. Reports to Manufacturing Associate Director / Director.

Responsibilities:

  • Ensures large scale commercial and clinical batch processing continuously meets SISPQ requirements.
  • Ensures compliance deviations are managed and closed in a timely manner to continuously meet lot disposition timelines.
  • Performs area manager function for complex investigations, ensuring robust investigations are performed while meeting disposition timelines. Leading investigations where it is deemed necessary.
  • Assesses, approves and oversees implementation of process related change controls.
  • Provides technical direction to resolve immediate process issues.
  • Participates in continuous process monitoring to identify areas of focus for continuous improvement and process robustness.
  • Develops programs and strategies to ensure continuous improvement and continued robustness of the large scale and clinical processes.
  • Key member of the manufacturing team in support of regulatory audits.
  • Interfaces regularly and builds strong working relationships with other departments, such as Facilities, Engineering, Process Development, Process Analytical Sciences, Regulatory, Quality Assurance and Quality Control.
  • Communicate with Supervisors/Managers regarding technical, compliance & production process related issues.
  • Oversees new product transfers by the MSAT/PMPD teams.
  • Performs cGMP audits of production area.
  • Ensures that safety standards are maintained. Supports departmental safety projects.
  • Performs personnel management functions including scheduling of holidays, personnel development, and performance evaluations.
  • Works closely with HR to ensure teams are managed adequately.
  • Works closely with staff to develop and manage individual and team goals and objectives.
  • Formulates and recommends manufacturing policies, schedules, procedures and programs.
  • Reviews, and/or approves Standard Operating Procedures, specifications, regulatory filing, or other controlled documents as needed.
  • Leads and implements continuous improvement initiatives.

 

Minimum Qualifications and Experience:

  • Bachelor, Master, or Doctorate degree in any of the physical or biological sciences, or chemical engineering and 10 -12 years biopharmaceutical/biotech work in a GMP production facility with BA/BS, alternatively 8 to 10 years with MA/MS, or 4-7 with PhD. 8+ years people management experience required;
  • Strong knowledge of recombinant protein manufacturing techniques and methods, which include purification and formulation of recombinant proteins;
  • Excellent interpersonal, written, and oral communication skills;
  • Substantial knowledge of cGMP’s and experience in engaging with regulatory authorities.
  • Self-aware, self-motivated, self-confident individual who is comfortable operating with minimal direction and who thrives in a dynamic environment
  • Able to engender trust and respect quickly as a manager of people, with a priority for the development of staff.

 

21355 – Manager Process Sciences - Limerick

Purpose:

Lead a team to manage all activities to ensure that manufacturing processes are supported. Responsible to support the Process Sciences Department through Process Validation, manufacturing floor support, product impact assessments, investigations, and technical evaluation as required. Active member of the Process Sciences management team.

Responsibilities:

  • Lead a team and manage all activities to assure that manufacturing processes are supported.
  • Responsible for developing a team such as development plans, upskilling and team forming.
  • Write, review and approve Process Validation protocols and reports.
  • Identification of process parameters and appropriate ranges to be included in process validation.
  • Provide on the floor support to Manufacturing (Cell culture and Purification)
  • Lead/Participate Process and Quality risk assessments.
  • Lead troubleshooting activities associated with the manufacturing process.
  • Provide technical support for manufacturing personnel to improve understanding of both cell culture and purification operations.
  • Review and approve manufacturing documentation such as manufacturing records, SOPs and batch sheets.
  • Develops/writes/plans and reviews protocols and activities for manufacturing support.
  • Serves as a subject matter expert (SME) for data trending and manufacturing support.
  • Presents and reviews process monitoring data to IOPS Management as necessary.
  • Investigates and reviews OOS and OOL IPCs investigations.
  • Performs, reviews and approves product impact assessment.
  • Performs, reviews and approves scientific investigations (EOE & DNF).
  • Communicate information on current process data and other IOPS initiatives which may impact process development and/or technology transfer.
  • Support the site through regulatory audits by providing technical expertise.
  • Work efficiently and effectively in a fast paced team-oriented environment to ensure maximum and high-quality output.

 

Minimum Qualifications and Experience:

  • Requires a BS/BA in Life Sciences, Biological Sciences or related field.
  • 7+ years of related experience in a GMP environment.
  • Previous experience in biological drug substance (DS) manufacturing.

 

21069 – Manager Manufacturing Technical Operations - Downstream - Limerick

Purpose:

Mgr/ Sr Mgr role, key member of the operations management team. Provides technical management and support to ensure key deliverables of the manufacturing department are achieved. Reports to Manufacturing Associate Director / Director.

Responsibilities:

  • Ensures large scale commercial and clinical batch processing continuously meets SISPQ requirements.
  • Ensures compliance deviations are managed and closed in a timely manner to continuously meet lot disposition timelines.
  • Performs area manager function for complex investigations, ensuring robust investigations are performed while meeting disposition timelines. Leading investigations where it is deemed necessary.
  • Assesses, approves and oversees implementation of process related change controls.
  • Provides technical direction to resolve immediate process issues.
  • Participates in continuous process monitoring to identify areas of focus for continuous improvement and process robustness.
  • Develops programs and strategies to ensure continuous improvement and continued robustness of the large scale and clinical processes.
  • Key member of the manufacturing team in support of regulatory audits.
  • Interfaces regularly and builds strong working relationships with other departments, such as Facilities, Engineering, Process Development, Process Analytical Sciences, Regulatory, Quality Assurance and Quality Control.
  • Communicate with Supervisors/Managers regarding technical, compliance & production process related issues.
  • Oversees new product transfers by the MSAT/PMPD teams.
  • Performs cGMP audits of production area.
  • Ensures that safety standards are maintained. Supports departmental safety projects.
  • Performs personnel management functions including scheduling of holidays, personnel development, and performance evaluations.
  • Works closely with HR to ensure teams are managed adequately.
  • Works closely with staff to develop and manage individual and team goals and objectives.
  • Formulates and recommends manufacturing policies, schedules, procedures and programs.
  • Reviews, and/or approves Standard Operating Procedures, specifications, regulatory filing, or other controlled documents as needed.
  • Leads and implements continuous improvement initiatives.

 

Minimum Qualifications and Experience:

  • Bachelor, Master, or Doctorate degree in any of the physical or biological sciences, or chemical engineering and 10 -12 years biopharmaceutical/biotech work in a GMP production facility with BA/BS, alternatively 8 to 10 years with MA/MS, or 4-7 with PhD. 8+ years people management experience required.
  • Strong knowledge of recombinant protein manufacturing techniques and methods, which include purification and formulation of recombinant proteins.
  • Excellent interpersonal, written, and oral communication skills.
  • Substantial knowledge of cGMP’s and experience in engaging with regulatory authorities.
  • Self-aware, self-motivated, self-confident individual who is comfortable operating with minimal direction and who thrives in a dynamic environment.
  • Able to engender trust and respect quickly as a manager of people, with a priority for the development of staff.

 

 

11197208 – Maintenance Technician - Athlone

Purpose:

The Biologics Process Maintenance Technician is responsible for the maintenance, repair, trouble-shooting and replacement of all production equipment in the Athlone facility. The main location for this role is within the Facility. This position is also responsible for assisting in the co-ordination and scheduling of maintenance works performed by service vendors in both the Biologics and Fill Finish Environment. The individual in this position is expected to represent company interests, objectives and policies in a professional and responsible manner. Daily duties will be guided by the Manufacturing Engineer in the area. The successful candidate, will report overall into the Snr. Manager for Manufacturing Engineering and the role will offer scope for both personal and career development. Note: This is a 12-month contract shift position.

Responsibilities:

  • Proactively ensuring that all Environmental, Health and Safety responsibilities are carried out according to EHS regulations and procedures.
  • Provide support to new equipment installations and product introductions.
  • Maintaining the Maintenance Quality System by adherence to all relevant SOP’s, policies and cGMP requirements.
  • Perform scheduled and unscheduled maintenance tasks in accordance with site policies and procedures.
  • Responding to equipment breakdowns in a timely manner.
  • Maintaining spare parts, change parts and equipment both within Manufacturing Areas and in the Engineering Stores.
  • Ensure the Maintenance Management System is maintained correctly.
  • Utilising and maintaining IT systems as required, e.g. Computerized Calibration Systems and Computerized Maintenance Management Systems.
  • Act as a subject matter expert for the Facilities and Maintenance group in relevant equipment and system root cause investigations and fill the role of lead investigator where required.
  • Assist in writing and revising Maintenance Standard Operating Procedures as required.
  • Filing and archiving of Facilities and Maintenance documentation.
  • Provide support to Operations, Validation, Engineering and Quality where required.
  • Complete training with new/junior Maintenance Technicians
  • Provide on-call support during operation, project and shutdown activities, as required.
  • Other duties as required.

 

Minimum Qualifications and Experience:

  • Associate Degree and/or technical certification in a mechanical, electrical or related field is required.
  • 5+ years’ experience performing facilities and maintenance support activities in a cGMP commercial manufacturing environment, preferably with experience on some or all of the following: Downstream Processing (Ultra or Dia-filration), Vial Filling Equipment (Isolator or RABs technology.)
  • Prior hands-on experience with CMMS and Computerized Calibration Systems.
  • Prior experience with Quality Management Systems.
  • Good interpersonal, communication and problem-solving skills.
  • Must be knowledgeable of the regulatory and GMP requirements for process equipment, instrumentation and calibration.
  • Knowledge of Six Sigma and lean systems is an advantage.
  • Ability to make informed and timely decisions that take into account the facts, goals, constraints, and risks associated.
  • A team player with a can do, pro-active attitude and a passion for improvement

 

11965 – QC Systems Integration Specialist - Carlow

Purpose:

To provide technical knowledge and complete the execution for the integration of Laboratory instruments with other systems such as LIMS while ensuring the continued manufacture and supply of quality pharmaceutical products in meeting the company’s Manufacturing Division priorities of: Compliance, Supply, Strategy and Profit Plan. The Laboratory systems integration Specialist has the responsibility for managing and executing projects primarily related to integrating laboratory standalone systems with other company software including LIMS and Empower without direct supervision. This includes managing and completing projects from end to end. This will include at minimum Change control, execution of User Acceptance Testing (UAT), procedure creation, LIMS static data building, training and all other required activities to implement the integration solution. The role may also be required to act as LIMS Site Administrator, for the site Laboratories and is required to be a subject matter expert in these areas. The role supports all internal customers including all Quality labs and Automation & IT. The role also supports external customers when required such as other company sites linked to Carlow and Global functions. A high level of self-motivation, knowledge, enthusiasm and drive is required. Reports to the Laboratory QC Systems & Instrumentation Manager.

Responsibilities:

  • Management of Lab projects for instrument integration from end to end including the physical execution of the project requirements.
  • An efficient support to all departments at Carlow including QC Microbiology, Quality Control and Quality Operations lab for issues pertaining to LIMS and Instrument integration and to be a subject matter expert for these areas.
  • Deliver training to all employees on the integrated systems.
  • Development and testing of LIMS static data builds. Create LIMS static data standard in relation to instrument integration.
  • Provide technical support to all users at Carlow.
  • Liaise with Global systems working groups.
  • Ensures data integrity requirements is incorporated and verified through the project implementation.
  • Represent Carlow in relation to Laboratoy systems and implementation in conjunction with global teams.
  • Management of system Change Controls.
  • Provide subject matter expertise in relation to Laboratory Systems.
  • Actively identifies and progresses continuous improvement opportunities. Ensures strict adherence to site policies/procedure and good manufacturing practices.
  • Coach and guide colleagues onsite and in the network on the use of Laboratory Systems.
  • Interpret customer needs, assess requirements and identify solutions to non-standard requests.
  • Ensure highest safety standards.
  • Required to comply with company Global Policies, Procedures and Guidelines, regulatory requirements and execute current Good manufacturing Practices (cGMP) in the performance of day to day activities and all applicable job functions.
  • Acts a LIMS Site Administrator providing support to the relevant departments to ensure LIMS builds are created in accordance with product/ material testing schedules.
  • Performs assessments and provides overview of systems from a data integrity perspective ensuring the highest standards are maintained.
  • Work collaboratively to drive a safe and compliant culture in Carlow.
  • May be required to perform other duties as assigned.

 

Minimum Qualifications and Experience:

  • Bachelor’s Degree or higher preferred; ideally in Science/IT or a closely related discipline.
  • Considerable experience and critical skills in the area of expertise that add value to the business; ideally in Laboratory Systems setting. Preferably Lab IT, Instrument Integration and LIMS.
  • Change Management Skills (CEM) with continuous improvements.
  • Excellent knowledge and experience of LIMS and Lab Instrumentation.
  • Knowledge of regulatory/ code requirements to Irish, European and International Codes, Standards and Practices.
  • Empower knowledge and experience is desired.
  • Proficiency in Microsoft Office and job-related computer applications required.
  • Laboratory Quality System.
  • Report, standards, policy writing skills required.
  • Planning and scheduling skills.
  • Demonstrable analytical and systematic problem solving.
  • Proven organizational skills.

 

12106 – Manufacturing Operations Manager - Cork

Purpose:

The External Manufacturing (ExM) Operations Manager will support the ExM Operations Director (Virtual Plan Manager) to satisfy customer demand at the External Manufacturing Partners. This role will support Pediatrics and Spray Dried Intermediates within the Drug Product/Devices Platform. The incumbent manages by achieving Compliance, Supply, Continuous Improvement & Cost working as part of the responsible cross functional teams and in partnership with external partners. The role requires strong influencing, leadership and communication skills to drive business outcomes. The role may require time at the manufacturing sites of responsibility to ensure ongoing success, and partners with an organization spanning Western Europe and the US.

Responsibilities:

  • Supporting the ExM Virtual Plant Manager (VPM), overseeing our company’s relationship with the contract manufacturer. The VPM serves as the air traffic controller of all information/interactions between company’s Manufacturing Division and the contract manufacturer and establishes boundaries and ground rules of engagement.
  • As required engage with the cross functional team (Supply Chain, Quality, Technical Operations, Planning) responsible for delivering daily/weekly/monthly/annual requirements at their external partner(s.)
  • Responsible for operational related activities as delegated by the VPM:
    • Compliance (Quality Risk management, Deviation Management, Product Release, Change Control.)
    • Meeting Demand.
    • Production Planning.
    • Materials Management (MRP entries.)
    • Logistics including shipping of product to the downstream location.
    • Technology issues.
    • Oversight of shop floor production.
    • Linking end to end (upstream and downstream) and with Supply Chain Management to ensure optimal flow of materials.
    • Represent the VPM in forums as delegated by the VPM.
  • Routine presence at external partners site on the production floor. Building a strong relationship with the site team and able to assess & diagnose with appropriate tools and resource the true current condition & risks at a partners site. Formulate in partnership with the external partner and the company’s cross-functional team action orientated and time bound improvement plans.
  • They work with the company’s team and external partner to understand capacity and future capacity based on agreed improvements.
  • Responsible for maintaining the integrity of the MSA (Master Supply Agreement) ensuring alignment with the Supply and Quality agreements and appropriate document revision and distribution control and for ensuring contract terms agreed upon are executed, including purchase orders, forecasts, deliveries, and approving invoice payments.
  • Responsible for inventory control. Depending on the location of goods (at External Party or at the company), They ensure adequate documentation of material disposition.
  • Supports periodic Business and Operations Review Meetings and the annual Hoshin Kanri Plan for the relationship with clear goals and targets, and annual “state of the union” presentation for the relationships s/he manages which includes successes and failures in order to leverage across ExM.
  • Supporting the VPM, plans strategically, understands broad CMO business environment, specific opportunities & potential partners in their operations area.
  • Specific to Commercialization of Pediatrics and Spray Dried Intermediate Products:
    • Responsible to ensure fulfillment of operations activities related to commercialization, new product introduction and commercial supply of pediatric and spray dried intermediate products.
    • Ensure commercial item code creation.
    • Ensure shipping lane set up and qualification of product in the shipping lane.
    • BOMs
    • Ensure Product standard cost set up.
    • Cold chain management system setup at external partner.
    • Understand product importation and exportation requirements.
    • Operations support for Product PPQs.
    • Operations support for packaging and artwork.
    • Is a delegate for the VPM as required.

 

Minimum Qualifications and Experience:

  • Bachelor’s degree minimum, with a degree in Engineering or Science and Business is preferred.
  • No less than ten (10) years’ experience in pharmaceutical manufacturing (operations, quality, technology, supply chain) roles with a significant portion in management/leadership positions.
  • Supply chain excellence knowledge and experience preferred.
  • Compliance – Deep understanding of GMP and EHS compliance and compliance risk.
  • World Class Supplier Mindset – proven Lean Six Sigma skills.
  • Business & Financial Acumen.
  • Depth of Manufacturing Knowledge.
  • Knowledge of SAP.

 

21168 – Supervisor QC HPLC - Limerick

Purpose:

Oversees the laboratory quality control testing of a variety of raw materials, products, in-process materials, or stability samples in support of the company’s quality programme.

Responsibilities:

  • Coordinate with members of Manufacturing, R & D, and Formulation to provide analytical support.
  • Supervise QC Analysts – distribute work load and monitor progress.
  • Supervise and perform product testing.
  • Review test reports.
  • Ensure QC Analysts receive proper training.
  • Attend interdepartmental meetings to keep informed of manufacturing priorities.
  • Ensure testing is performed accurately and in compliance with cGMP procedures, established regulatory requirements, SOPs, and other approved test methods.
  • Oversee or conduct laboratory investigations and generate reports in response to Deviations and OOS/OOT.
  • Review and approve method protocols, reports and SOPs.
  • Assist in the preparation for internal/customer/regulatory inspections.
  • Proactively identify and implement lab process improvements, lean initiatives.
  • Ensure that CAPAs and Change Controls are initiated and completed on time and in accordance with site procedures.
  • Train, develop and mentor direct reports and effectively manage the performance of individuals.
  • Ensure a safe working environment within the laboratory.

 

Minimum Qualifications and Experience:

  • Requires BS/BA in Life Sciences or related field.
  • 5+ years of relevant experience, preferably in the pharmaceutical or biotechnology industry.
  • Relevant experience may be considered in lieu of educational requirement.
  • Previous supervisory/leadership experience required.

 

21216 – QC Supervisor – Sample Management - Limerick

Purpose:

Oversee daily operation and communication for samples submitted from Manufacturing, QA Validation, and QC labs. Ensure chain of custody is maintained and timely delivery of samples to the labs.

Responsibilities:

  • Oversee daily operation of Microbiology Laboratory.
  • Scheduling and organizing daily/weekly tasks for team.
  • Developing and coaching of leads analysts.
  • Work cross functionally to meet company and department goals.
  • High level of customer services to external and internal departments.
  • Oversee and maintain appropriate procedures to ensure chain of custody for QC samples is maintained.
  • Ensure sample availability and correct storage is maintained.
  • Reference standard inventory control for all QC labs.
  • Oversight of microbiological testing of intermediates (in process) and finished product, equipment, cleaning and process validation samples or any other incoming materials.
  • Ensure testing is performed accurately and in compliance with cGMP procedures, established regulatory requirements (USP), SOPs and other approved test methods.
  • Support internal and regulatory audits.
  • Approval of standard operating procedures (SOP.)
  • Review and approval of quality system records (Investigations/Deviations.)
  • Lead cross functional investigations.

 

Minimum Qualifications and Experience:

    • Requires BS/BA in Life Sciences or related field.
    • 5+ years of relevant experience, preferably in the pharmaceutical or biotechnology industry.
    • Some previous supervisory/leadership experience.
    • GMP compliance and inspection experience.
    • Experience with regulatory guidelines related to Quality control.
    • Experience with sample management, data review, trending, and limit assessment.
    • Experience with Lab Information Management Systems (LIMS.)
    • Technical writing experience including SOPs, investigations, and validations.

 

 

21233 – QC Supervisor – Chemistry - Limerick

Purpose:

Oversees the laboratory quality control testing of in-process, stability, and final drug products.

Responsibilities:

  • Coordinates with members of Manufacturing, R & D, and Formulation to provide analytical support.
  • Supervises QC Analysts, distributes work load, and monitors progress.
  • Supervises and performs product testing where required.
  • Reviews test results to ensure compliance with standards; reports any quality anomalies.
  • Ensures QC Analysts receive proper training.
  • Attends meetings to keep informed of manufacturing priorities.
  • Ensures that safety standards are maintained.
  • Ensures compliance with applicable cGMP regulations and SOPs.
  • Conducts laboratory investigations and generates reports in response to invalid assays, Deviations, OOS/OOT.
  • Performs personnel management functions including time sheet submissions, scheduling of vacations, personnel development, and performance evaluations.
  • Responsible for all Safety and cGMP activities of associates working in Quality Control Chemistry.
  • Writes and revises control test procedures and SOPs.
  • Interacts with outside customers or functional peer groups.
  • May be responsible for maintaining a specific project.
  • Maybe involved in establishing the transfer of methodology from R&D.
  • Initiates and completes CAPAs and Change Controls in accordance with site procedure.
  • Maybe required to review and approve Laboratory Investigations.
  • Act as area SME for Internal and External Inspections.
  • Perform minimally monthly performance feedback meetings with direct reports.
  • Represent area management at leadership meetings as required.
  • Escalates all performance issues to management and/or HR.

 

Minimum Qualifications and Experience:

  • A third level qualification (BSc degree or higher) in chemistry, biology or related field. MS preferred.
  • Preferably with 5+ years progressive, hands-on work experience working in laboratory to cGMP regulatory guidelines within the biopharmaceutical industry.
  • Relevant experience may be considered in lieu of educational requirement.
  • Supervisory/leadership experience required.
  • Excellent Communication skills, both verbal & written.
  • Experience with electronic systems such as LIMS, Empower, Qumas, eDoc, Trackwise etc., is an advantage.
  • Adaptable, flexible and willing to travel when needed.
  • Collaboration and team work. Maintains the highest standards of ethical behaviour.
  • Results and performance driven.
  • Strong analytical ability and associated problem solving.
  • Good time management and attention to detail.
  • Knowledge and proficient in the use of Microsoft products including, Excel, Word and Powerpoint.
  • Preferred Laboratory Experience in one or more of the following areas:
    • HPLC
    • UPLC
    • UV-Vis spectrophotometry.
    • Densitometry
    • Compendial chemistry testing techniques including pH, conductivity, appearance and osmolality.

 

19293 - Lead Microbiologist - Limerick

Purpose:

Oversees the laboratory quality control testing of in-process samples, sampling of utilities and manages the environmental monitoring programme.

Responsibilities:

  • Manage a team of laboratory analysts within the QC microbiology department involved in the analysis of intermediates (in process) and bulk drug substance in a cGMP regulatory environment. Distribute work load and monitor progress.
  • Manage the environmental monitoring programme, including surface, settling and viable and non-viable particulate air monitoring of aseptic operations and controlled areas
  • Manages product testing to ensure efficient and compliant operations.
  • Ensure that all work carried out is in compliance with the required regulatory standards, conforms to company policies and standard operating procedures (SOPs.)
  • Review and approve method protocols, reports and SOPs.
  • Assist in the preparation for internal/customer/regulatory inspections.
  • Ensure a safe working environment within the laboratory.
  • Proactively identify and implement lab process improvements, lean initiatives.
  • Oversee or conduct laboratory investigations and generates reports in response to invalid assays, Deviations, OOS/OOT.
  • Ensure that CAPAs and Change Controls are initiated and completed on time and in accordance with site procedures.
  • Present analytical data reports clearly and concisely to senior management, including QC performance metrics and trends.
  • Ability to train, develop and mentor direct reports and effectively manage the performance of individuals.
  • May be required to work shift.

 

Minimum Qualifications and Experience:

  • Requires BS/BA in Life Sciences or related field.
  • 6+ years of relevant experience, preferably in the pharmaceutical or biotechnology industry.
  • Previous supervisory/ leadership experience in a laboratory environment is required.

 

21193 – Associate Manager – Raw Materials - Limerick

Purpose:

Responsible for the QC Raw Materials laboratory team. Has technical responsibility for all chemical aspects of QC testing.

Responsibilities:

  • Coordinates with members of Facilities, Manufacturing, Stability, and Business Ops to provide analytical support.
  • Manages QC Analysts, distributes work load, and monitors progress.
  • Manages product testing to ensure efficient and compliant operations.
  • Reviews test reports.
  • Ensures QC Analysts receive proper training.
  • Attends meetings to keep informed of manufacturing priorities.
  • Ensures that safety standards are maintained.
  • Ensures compliance with applicable cGMP regulations and SOPs.
  • Investigates atypical and OOS test results as necessary.
  • Manage assay transfer internally from R&D to the QC laboratory or from PAS to the QC Laboratory.
  • Manage assay transfer externally from QC laboratory to contract labs, includes audits if needed.
  • Manages QC projects including analytical commitments for Regulatory filing, follow-up actions for general GMP inspections and its readiness.
  • Track and coordinate major analytical investigation
  • Track and monitor timeline of analytical validation projects.
  • Monitor the team performance for Compliance events, track, assist and organize continuous improvement events.
  • Interact with Regulatory Agencies as needed to ensure cGMP compliance.
  • Special projects as assigned.
  • Performs personnel management functions including time sheet submissions, scheduling of vacations, personnel development/feedback, and performance evaluations.

 

Minimum Qualifications and Experience:

  • Requires BSc/BA in Life Sciences or related field.
  • 6+ years of relevant experience, preferably in the pharmaceutical or biotechnology industry.
  • Previous supervisory/ leadership experience in a laboratory environment is required.
  • Thorough understanding of Analytical Testing in a cGMP environment for Raw Materials, Wet Chemistry and HPLC assays.

 

21189 – Associate Manager – Chemistry - Limerick

Purpose:

Oversees the activities of the Quality Control Sample Management group in addition to laboratory quality control testing of Raw Materials and plant utilities in support of the company’s quality programme. This involves oversight of the onsite Contract Analysts Group.

Responsibilities:

  • Coordinate with members of Manufacturing, Process Science and Supply Chain to provide analytical support.
  • Supervise QC Analysts – distribute work load and monitor progress.
  • Supervise and perform product testing.
  • Review test reports.
  • Ensure QC Analysts receive proper training.
  • Attend interdepartmental meetings to keep informed of manufacturing priorities.
  • Ensure testing is performed accurately and in compliance with cGMP procedures, established regulatory requirements, SOPs, and other approved test methods.
  • Oversee or conduct laboratory investigations and generate reports in response to Deviations and OOS/OOT.
  • Review and approve method protocols, reports and SOPs.
  • Assist in the preparation for internal/customer/regulatory inspections.
  • Manage assay transfer internally from R&D to the QC laboratory or from PAS to the QC laboratory.
  • Proactively identify and implement lab process improvements, lean initiatives.
  • Ensure that CAPAs and Change Controls are initiated and completed on time and in accordance with site procedures.
  • Train, develop and mentor direct reports and effectively manage the performance of individuals.
  • Ensure a safe working environment within the laboratory.
  • Oversee and maintain appropriate procedures to ensure chain of custody for QC samples is maintained.
  • Ensure sample availability and correct storage is maintained.
  • Reference standard inventory control for all QC labs.

 

Minimum Qualifications and Experience:

  • Requires BS/BA in Life Sciences or related field.
  • 6+ years of relevant experience, preferably in the pharmaceutical or biotechnology industry.
  • Previous supervisory/ leadership experience in a laboratory environment is required.

 

21045 – Senior QC Lab Instrumentation Analyst - Limerick

Purpose:

Support the Quality Control (QC) and Process Sciences (PS) departments by maintaining their laboratory instrumentation in an operational, qualified state. This entails ensuring both instrument hardware and software qualifications are completed in a timely manner and keeping them in a qualified state.

Responsibilities:

  • Function as super user for the Empower 3 chromatography data server. In this capacity, assist analysts in troubleshooting issues and creating custom calculations and processing methods.
  • Establish best in class IQ/OQ/PQ processes and execution for laboratory instrumentation and controlled temperature units.
  • Develop and write protocols for instrument qualification/validation studies.
  • Assist in performing instrument qualification/validation experiments.
  • Help troubleshoot instrument performance issues.
  • Work with the vendor to schedule and complete necessary repairs.
  • Complete instrument related documents on behalf of QC.
  • Collaborate with Engineering/Metrology department to ensure equipment calibrations are completed on time.
  • Construct instrument interface with LIMS.
  • Develop a working knowledge of all software platforms in QC and troubleshoot them as necessary – for example Empower, SoftMax Pro.
  • Tabulate results and write summary reports of instrument and software uses and qualification studies.
  • Help to organize the new instrument evaluation and purchase activity.
  • Present status updates at group and possibly at interdepartmental meetings.
  • Produce and maintain accurate and GMP compliant records.
  • Write SOPs relevant to laboratory instrument and software operation.
  • May perform routine quality control in-process, release, and stability testing, as needed.

 

Minimum Qualifications and Experience:

  • Requires BS/BA in Chemistry or Biology; may consider another degree discipline with relevant experience.
  • 3 – 5 years relevant experience in a cGMP environment is required.
  • Experience with executing IQ/OQ/PQ protocols and administering software databases and working knowledge of change control in the pharmaceutical industry would be advantageous.

 

21105 – QC Stability Coordinator - Limerick

Purpose:

Performs a variety of activities to administer the stability program and manage data generated in support of the company’s quality program.

Responsibilities:

  • Coordinates with other departments to identify material to be put on stability.
  • Authors stability protocols and obtains necessary approvals prior to study initiation.
  • Performs review of analytical data and compiles into a central database.
  • Provides stability data necessary for the submission of various regulatory documents.
  • Provides stability data to other departments upon request.
  • Orders stability chambers and related equipment, as needed.
  • Maintains stability chamber inventory and monitors chamber performance.
  • Removes samples from chambers according to protocol pull schedules and submits to appropriate testing group.
  • Prepares samples for inclusion in stability studies (aliquotting, labeling, distribution to appropriate stability chamber.)
  • Interacts with outside customers or functional peer groups.
  • May be responsible for maintaining a specific project.
  • Complies with all pertinent regulatory agency requirements.
  • Participates in required training activities.

 

Minimum Qualifications and Experience:

  • Requires BS/BA in Life Sciences or related field or equivalent combination of education and experience.

 

20152 – QC Micro Analyst - Limerick

Purpose:

Perform a wide variety of microbial testing to support raw material, utilities, in-process and bulk drug substance manufacture in a cGMP regulatory environment. Reporting to the QC Laboratory Lead/Supervisor.

Responsibilities:

  • Enters a Laboratory Cleanroom to collect and log samples for microbial analysis.
  • Performs bioburden and endotoxin sample analysis in accordance with standard operating procedures (SOPs.)
  • Performs or supports the sample analysis for microbial identification.
  • Performs environmental monitoring including surface, settling and viable and non-viable particulate air monitoring of aseptic operations and controlled areas.
  • Performs acceptance testing of commercially prepared microbiological culture media.
  • Autoclaves microbiological media and laboratory waste as needed.
  • Ensures that all work carried out is in compliance with the required regulatory standards, conforms to company policies and standard operating procedures (SOPs.)
  • Completes own test records on time and peer reviews data from other analysts for accuracy and completeness.
  • Assist in the design and set-up of the QC microbiology laboratory and selection/ implementation and calibration of laboratory instruments.
  • Participate in microbiological validations as needed for drug substance, in-process controls, buffers and clean utilities qualification program.
  • Assist manufacturing personnel in the identification of microbiological root cause analysis and provide technical advice as needed.
  • Participates in the transfer of methodology from other test facilities.
  • Maintains laboratory reagents, media and supplies.
  • Conducts laboratory investigations and generates reports in response to invalid assays, Deviations, OOS/OOT.
  • Initiates and completes CAPAs and Change Controls in accordance with site procedures.
  • Writes new and updates current SOPs as needed.
  • Provides training to other analysts in the QC group.
  • Presents analytical data reports clearly and concisely to management.
  • Proactively identifies and implements lab process improvements, lean initiatives.
  • Performs other duties relevant to the QC laboratory position as required.

 

Minimum Qualifications and Experience:

  • BS/BA in a scientific/technical discipline.
  • 1 – 2 years hands-on work experience in a regulated QC Microbiology laboratory within the biopharmaceutical industry.
  • Experience with electronic systems such as LIMS, Qumas, eDoc, Trackwise etc., is an advantage.
  • Excellent communication skills, both verbal & written.
  • Adaptable and flexible, willing to travel when needed.
  • Collaboration and team work. Maintains the highest standards of ethical behaviour.
  • Results and performance driven.
  • Strong analytical ability and associated problem solving.
  • Good time management and attention to detail.
  • Knowledge and proficient in the use of Microsoft products including, Excel, Word and Powerpoint.
  • Preferred Laboratory Experience.
  • Microbiology
  • Bioburden
  • Microbial Identification.
  • Water Testing – Endotoxin.
  • Environmental monitoring.
  • Cleaning and validation studies.
  • Familiar with USP, JP and EP methodology.

 

12062 – Project Automation Engineer - Carlow

Purpose:

Reporting to the Carlow AIT Projects/OEM Lead, specifically responsible for OEM Systems. This candidate will be required to work closely with the Carlow AIT teams responsible for the full Automation and IT scope and with vendors / partners with responsibility for delivery of systems. The candidate will be required to work in a cross functional team (AIT, QA, C&Q) to introduce new systems & equipment to the site.

Responsibilities:

  • Work on OEM projects.
  • Develop and/or review SDLC deliverables, compliant with company standards, including but not limited to:
    • Requirements Specifications.
    • Requirements Traceability Matrix.
    • Functional Specification.
    • Design Specification.
    • Code Review.
    • Test specification/test script.
    • Etc.
  • Work closely with vendors of OEM equipment to ensure deliverables meet project requirements, including the interfacing of new OEM equipment with existing site systems, incl. MES, DCS and Pi Historian.
  • Work closely with the QAIT function and ensure their requirements are met in all deliverables.
  • Participate in Hardware and Software FATs and SATs.
  • Provide input to the development of project schedules and document trackers.
  • Participate in, and support, relevant project meetings.
  • Participate and support data mapping of new system to ensure end to end data flow requirements.
  • Liaise with stakeholders on the overall project to ensure clear communication between all parties.
  • Required to comply with Global Policies, Procedures and Guidelines, regulatory requirements and execute current Good manufacturing Practices (cGMP) in the performance of day to day activities and all applicable job functions.

 

Minimum Qualifications and Experience:

  • Minimum of 10 years’ experience in a similar role, ideally in the Pharmaceutical industry.
  • Minimum of 1 year experience in the Pharmaceutical industry.
  • Strong experience in one or all of the following systems: Siemens PLCs, HMIs and Historian Software.
  • Siemens PLC experience (S7) is a must.
  • Previous project experience required working with vendors.
  • Previous experience with IQ, OQ and project documentation.
  • Usual place of work will be in Carlow, Ireland. The successful candidate may sometimes be required to attend meetings at other sites or off-site.
  • NOTE: Due to current COVID restrictions the place of work can be temporarily agreed with the candidate where the project state allows this.
  • Excellent computer skills, proficient in the use of the following Microsoft tools: Excel, SharePoint, Word and PowerPoint.
  • Strong interpersonal and communication skills (verbal and written.)
  • Relevant Computer Science or Engineering degree or equivalent.
  • Fluent in English, written and verbal.

 

12005 – Buyer - Dublin

Responsibilities:

  • Execute purchasing transactions in SAP for Direct materials required for the Manufacturing plan.
  • Monitor order acknowledgements and delivery schedules and manage potential issues with vendors.
  • Communicate delivery schedules to other internal functions such as Planning, Warehouse, and QC functions.
  • Act as the primary transactional point of contact with Direct material vendors.
  • Review and approve vendor invoices for Direct materials – resolve any discrepancies in a timely manner with the vendor and internal stakeholders.
  • Monitor vendor performance (delivery, cost, quality) according to the company’s procurement policies and summarise for regular vendor appraisal meetings with site Procurement. Drive vendor performance improvements with Procurement, if required.
  • Manage vendor complaints and collaborate with QA and Procurement. Escalate critical issues if required according to internal procedures.
  • Ensures ethical and financial compliance when liaising with suppliers.

 

Minimum Qualifications and Experience:

  • Purchasing/Procurement or Supply Chain degree is required – a Diploma in these areas with relevant buying experience will also be considered.
  • A Purchasing/Procurement certification is beneficial.
  • Experience in a Purchasing function is required, preferably in the pharmaceutical industry.
  • SAP experience (or equivalent ERP system) is required.
  • Strong numeracy and data accuracy skills are required.
  • Ability to develop and maintain operational relationships with vendors across multiple cultures is required.
  • Ability to work with external and internal stakeholders across multiple functions and levels is required.
  • Ability to communicate in a clear and concise manner with vendors and other stakeholders is required.

 

12039 – Supply Chain – Supplier Complaints - Carlow

Purpose:

This individual will work within the supply chain Materials and SAP team at the site. They will be responsible for initiating and managing supplier complaints. This requires review and progress of the complaints at the site cross-functional MRB meeting and liaising with Supplier Performance and Development Management (SD&PM) team and the Supplier for investigation completion. The final supplier quality report for the investigation will be completed by the supplier complaint process steward for review and sign-off. Relationship development with key site suppliers and SD&PM for efficient issue resolution ensures on-time complaint close out. Material management process also includes the management of supplier change notifications and the new material introduction process. Ensure that objectives are effectively achieved, consistent with Company requirements to ensure compliance, safety and reliable supply to our customers. Reports to the Associate Director, Supply Chain Management – EPM and SAP.

Responsibilities:

  • Responsible for the processing of supplier complaints, ensuring that they are raised investigated and closed in accordance with site and global procedures. This includes the resolution of the inventory associated with supplier complaint and requiring certificate of destruction / discards as required.
  • Responsible for completion of the Material introduction process at Carlow ensuring that all suppliers and materials are approved for use on site in compliance with site and Global procedures. This includes the creation and maintenance of Approved Material files including Material Specification and purchasing and distribution documentation as required. Assist in changes to existing materials or suppliers on site and the implementation of dual sourcing. This involves close collaboration with the Technical Engineering, IPT and Quality teams. Coordinates and facilitates the Material Review board Cross Functional Assessment team.
  • Responsible for ensuring SCN’s (Supplier Change notifications) are implemented in a timely manner to ensure all SCN’s are implemented, in accordance with site and global procedures, prior to affected materials being delivered to /used on site. Includes the management of site supplier change controls.
  • Ensure that objectives are effectively achieved, consistent with Company’s requirements to ensure compliance, safety and reliable supply to our customers.
  • Drive compliance with Global Policies, Procedures and Guidelines, regulatory requirements and execute current Good manufacturing Practices (cGMP) and good documentation practices (GDP) in the performance of day to day activities and all applicable job functions. Target Right First Time (RFT), 100% of the time.
  • Drive continuous improvement by leading and active participation in investigations and investigation reports, execution/development of change control, and contribution to Kaizen events as appropriate. Manage root cause analysis of issues, using standard tools and methods, to resolve associated issues e.g. Fishbone diagrams, 5 why’s etc.; oversee and implement subsequent corrective action through the change management system.
  • Work collaboratively to drive a safe and compliant culture in Carlow.
  • May be required to perform other duties as assigned.

 

Minimum Qualifications and Experience:

  • Bachelor Degree or higher preferred; ideally in a Science, Engineering or Other Technical discipline SAP Knowledge essential.
  • A minimum of 5 years’ previous experience.
  • Experience supporting quality related issues.
  • Experience working with quality management systems.
  • Change Control/ Change Management experience preferable.
  • Green Belt preferable.
  • Considerable experience in a comparable role; contributing to the business at a directional, strategic level; ideally in a manufacturing, preferably GMP setting.
  • Knowledge of regulatory/code requirements to Irish, European and International Codes, Standards and Practices.
  • Understanding of business and operations management models and their application.
  • Ability to complete investigations and excellent report writing skills.
  • Excellent use of Excel and generation of report / standards and policy writing skills required.
  • Lean Six Sigma Methodology experience desired.
  • Having a strong safety ethos.
  • Excellent communication, presentation and interpersonal skills, to interface effectively with all levels of colleagues and with external customers in a team orientated manner.
  • Understand the specific responsibilities of all Carlow functions as they relate to one’s own department as well as the network governance groups.
  • Strong influence skills.
  • Have shown the ability to effectively manage complex projects across multiple disciplines
  • Demonstrate analytical and systematic problem-solving skills.
  • Effective time management and multi-tasking skills.
  • Trouble shooting skills.
  • Goal/results orientated.
  • Excellent attention to detail.
  • Self-motivated and Flexible.
  • Strong change management skills.
  • Effective conflict resolution & Negotiation skills.
  • Strategy planning and development.
  • Risk management skills.

 

 

12040 – Supply Chain – Supplier Complaints - Carlow

Purpose:

This individual will work within the supply chain Materials and SAP team the site. They will be responsible for initiating and managing supplier complaints. This requires review and progress of the complaints at the site cross-functional MRB meeting and liaising with Supplier Performance and Development Management (SD&PM) team and the Supplier for investigation completion. The final supplier quality report for the investigation will be completed by the supplier complaint process steward for review and sign-off. Relationship development with key site suppliers and SD&PM for efficient issue resolution ensures on-time complaint close out. Material management process also includes the management of supplier change notifications and the new material introduction process. Ensure that objectives are effectively achieved, consistent with Company requirements to ensure compliance, safety and reliable supply to our customers. Reports to the Associate Director, Supply Chain Management – EPM and SAP.

Responsibilities:

  • Responsible for the processing of supplier complaints, ensuring that they are raised investigated and closed in accordance with site and global procedures. This includes the resolution of the inventory associated with supplier complaint and requiring certificate of destruction / discards as required.
  • Responsible for completion of the Material introduction process at Carlow ensuring that all suppliers and materials are approved for use on site in compliance with site and Global procedures. This includes the creation and maintenance of Approved Material files including Material Specification and purchasing and distribution documentation as required. Assist in changes to existing materials or suppliers on site and the implementation of dual sourcing. This involves close collaboration with the Technical Engineering, IPT and Quality teams. Coordinates and facilitates the Material Review board Cross Functional Assessment team.
  • Responsible for ensuring SCN’s (Supplier Change notifications) are implemented in a timely manner to ensure all SCN’s are implemented, in accordance with site and global procedures, prior to affected materials being delivered to /used on site. Includes the management of site supplier change controls.
  • Ensure that objectives are effectively achieved, consistent with Company’s requirements to ensure compliance, safety and reliable supply to our customers.
  • Drive compliance with Global Policies, Procedures and Guidelines, regulatory requirements and execute current Good manufacturing Practices (cGMP) and good documentation practices (GDP) in the performance of day to day activities and all applicable job functions. Target Right First Time (RFT), 100% of the time.
  • Drive continuous improvement by leading and active participation in investigations and investigation reports, execution/development of change control, and contribution to Kaizen events as appropriate. Manage root cause analysis of issues, using standard tools and methods, to resolve associated issues e.g. Fishbone diagrams, 5 why’s etc.; oversee and implement subsequent corrective action through the change management system.
  • Work collaboratively to drive a safe and compliant culture in Carlow.
  • May be required to perform other duties as assigned.

 

Minimum Qualifications and Experience:

  • Bachelor Degree or higher preferred; ideally in a Science, Engineering or Other Technical discipline SAP Knowledge essential.
  • A minimum of 5 years’ previous experience.
  • Experience supporting quality related issues.
  • Experience working with quality management systems.
  • Change Control/ Change Management experience preferable.
  • Green Belt preferable.
  • Considerable experience in a comparable role; contributing to the business at a directional, strategic level; ideally in a manufacturing, preferably GMP setting.
  • Knowledge of regulatory/code requirements to Irish, European and International Codes, Standards and Practices.
  • Understanding of business and operations management models and their application.
  • Ability to complete investigations and excellent report writing skills.
  • Excellent use of Excel and generation of report / standards and policy writing skills required.
  • Lean Six Sigma Methodology experience desired.
  • Having a strong safety ethos.
  • Excellent communication, presentation and interpersonal skills, to interface effectively with all levels of colleagues and with external customers in a team orientated manner.
  • Understand the specific responsibilities of all Carlow functions as they relate to one’s own department as well as the network governance groups.
  • Strong influence skills.
  • Have shown the ability to effectively manage complex projects across multiple disciplines.
  • Demonstrate analytical and systematic problem-solving skills.
  • Effective time management and multi-tasking skills.
  • Trouble shooting skills.
  • Goal/results orientated.
  • Excellent attention to detail.
  • Self-motivated and Flexible.
  • Strong change management skills.
  • Effective conflict resolution & Negotiation skills.
  • Strategy planning and development.
  • Risk management skills.

 

11163626 – Documentation Specialist - Dublin

Purpose:

This position is responsible for actively participating in continuous improvement process mapping events and translating the output of those events into Standard Operating Procedures (SOP) and Work Instructions (WI.) In this role, you should have excellent technical writing skills, relationship building and problem-solving skills. A high attention to detail and excellent verbal and written communications skills are vital to success in the role. High proficiency in MS word is essential.

Responsibilities:

  • Active participation in Continuous Improvement Projects.
  • Writing and revision of Standard Operating Procedures (SOPs.)
  • Track documents through approval process and work with approvers to deliver documents in line with Quality Control project plans.
  • Provide training of revised/new procedures/processes to company staff.
  • Identify process improvements within the function and drive the initiative forward to implementation and effectivity.
  • Comply with internal SOP’s, standards and associated training.
  • Support the Quality Control, with responsibility to develop processes.
  • Responsible for assigned CAPA’s, Change Controls & Deviations program and initiate Corrective Action plans in the company’s Quality Management System, TrackWise.
  • Maintain regular and proactive communication with all stakeholders.

 

Minimum Qualifications and Experience:

  • Degree in science/pharmaceutical related subject.
  • At least 5 years’ working in Pharmaceutical quality operations.
  • Knowledge and understanding of GMP/GDP standards.
  • Strong problem-solving experience.
  • Familiar with continuous improvement initiatives.
  • Experience of SOP authoring and document management processes.
  • Highly Computer literate, with MS Office (Word, Excel.)
  • Experience of provision training to others.
  • Experience of working in a GMP Quality Control Laboratory or Quality Assurance Unit.

 

12026 – De-Commissioning Engineer - Cork

Purpose:

The Sterile IPT De-Commissioning and Validation Engineer will provide technical expertise to the sterile technical team for the duration of the facility decommissioning project. The team working style is one of collaboration, coaching and facilitating to provide technical solutions to the IPT team to support a High-Performance Organisation.

Responsibilities:

  • The Sterile IPT De-Commissioning and Validation Engineer is accountable for supporting all technical components of the process to deliver an effective and efficient facility upgrade.
  • The Sterile IPT De-Commissioning and Validation Engineer is responsible for actively participating in the Tier process to manage technical projects and proactively resolve issues before they impact the business priorities.
  • The Sterile IPT De-Commissioning and Validation Engineer will be an active member within the cross functional project team who will lead and execute all de-commissioning equipment close out activities for the assigned portion of the project.
  • The Sterile IPT De-Commissioning and Validation Engineer will participate and comply with the company Quality Management System (QMS) requirements and the company’s EHS guidance chapters, including ownership, as relevant to you.
  • Provide ongoing coaching and support to the cross functional team members, to share their technical knowledge and promote best practices.
  • Ensure delivery of all assigned tasks and activities for the project as assigned.
  • Provide Technical stewardship, equipment resource planning and validation schedules.
  • Ensure highest Quality & Compliance standards.
  • Provide Technical expertise within a wide range of technical projects within the IPT, such as the execution of new equipment, authoring and execution of protocols, completion of Risk assessment, and generation of project documentation while adherence to safety requirements for all activities.

 

Minimum Qualifications and Experience:

  • Degree or 3rd level qualification (Production, Mechanical, Process, Industrial, Electrical.)
  • At least 3-5+ years’ experience in the Pharmaceutical industry or a similar operating environment with experience in a Technical role in a manufacturing environment.
  • Demonstrated knowledge in more than one pharmaceutical and/or chemical manufacturing operation (e.g. manufacturing, quality, engineering, etc.)
  • Knowledge of and experience in De-commission and validation activities.
  • A strong understanding of regulatory and validation requirements.
  • Demonstrated leadership skills with a continuous improvement focus.
  • Project Management Experience leading projects.
  • Desirable for Six Sigma Green Belt.
  • Desirable project management qualification such as PMP etc.
  • Process and technology background.
  • Demonstrated ability to work on own initiative within the parameters of a highly regulated GMP environment.
  • High technical writing standard and strong attention to detail.
  • Ability to generate, review, and execute validation protocols and reports.
  • Demonstrated successes in a team environment, such as project teams, Six Sigma team, PITs etc.
  • Demonstrated high level of problem solving and facilitation skills.
  • Advanced PC skills such as Excel, Word, PowerPoint.
  • Stakeholder management of multi decision makers, colleagues, peers and cross functional teams.

 

 

12015 – IT Project Lead Engineer - Carlow

Purpose:

Reporting to the site Automation and IT (AIT) Technical Lead, with specific responsible for the ‘IT’ workstream (1 of 8 workstreams within the AIT program.) The IT Workstream lead will drive the development and provision of all IT active equipment. Manage the provision and configuration of Shop Floor Hardware components such as HMI’s, OIT’s, Label Printers, Bar Code Scanners, and other hardware devices required in manufacturing or support areas.

Responsibilities:

  • Working with each workstream lead to understand and capture their IT Requirements and assist in the provision of same.
  • Liaise with the global Unified Communication team, lead the development, configuration and installation of the AV requirements of conference/meeting rooms, IDEA centre, and common area AV needs.
  • Planning, in conjunction with the Scheduler and Workstream Leads.
  • Risk, Issue, Action and Decision management.
  • Ensure the appropriate quality documents, such as Quality Assurance (QAPs) test plans, Quality assurance summary reports (QASR) are in place, aligned with the qualification strategy of the project.
  • The candidate will be required to work closely with team members both global and local, with responsible for the full Automation and IT scope, and with vendors / partners with responsibility for delivery of systems, on which the hardware and AV components will rely.
  • The candidate will review and ensure vendors compliance with company quality and various “playbook” standards.
  • Assess the needs of the process, applications, environment, and users, to develop a shop floor hardware infrastructure for use in a sterile manufacturing facility and supporting areas.
  • Develop SDLC deliverables, compliant with company standards, to ensure consistent implementation of hardware devices and AV components.
  • Align with the company’s HPV program: leverage existing hardware designs, documents & expertise where feasible.
  • Provide guidance and support to AIT team members tasked with delivery of key systems.
  • Provide input to the development of realistic project schedules and document trackers.
  • Work closely with suppliers / integrators to ensure compliance with company standards.
  • Participate in, and support, relevant project meetings.
  • Liaise with the various stakeholders on the overall project to ensure clear communication between all parties in relation to AIT validation requirements.

 

Minimum Qualifications and Experience:

  • Relevant Computer Science or Engineering degree or equivalent.
  • Minimum of 8 years’ experience in a similar role, ideally in the Pharmaceutical industry.
  • Expert knowledge of GAMP5.
  • Strong experience in one or all the following systems: SAP, Werum PasX, OSI PI.
  • Usual place of work will be in Carlow, Ireland. The successful candidate may sometimes be required to attend meetings at other sites, off-site or in Cork.
  • Excellent computer skills, proficient in the use of the following Microsoft tools: Excel, SharePoint, Word and PowerPoint.
  • Strong interpersonal and communication skills (verbal and written.)
  • Fluent in English, written and verbal.

 

 

11985 – Technical Specialist - Cork

Purpose:

The Vaccines Operations team are currently recruiting for a Technical Specialist to provide Technical expertise to the manufacturing team. This role will report to a Process Lead, V116 Operations team. The Technical Specialist will demonstrate a high level of innovation, enthusiasm and drive to deliver technical excellence for characterisation and optimisation of manufacturing processes and will be accountable for providing scientific and technical support to the operations team for effective and efficient running of all operations activities to a defined daily, weekly and monthly schedule as agreed with our customers. This requires a flexible, collaborative, and coaching style and will require a substantial amount of his/her time within the IPT process, engaging and communicating with all IPT members.

Responsibilities:

  • Provide Technical Support for the commissioning and qualification of the drug substance manufacturing process.
  • Work with site support groups to deliver qualified raw materials and consumables for the manufacturing process.
  • Support the technology transfer of drug substance manufacturing process through effective collaboration with business partners and customers.
  • Author, review and approve manufacturing documentation associated with transferred processes.
  • Troubleshoot manufacturing issues and lead investigations through scientific problem-solving approaches.
  • Partner with quality groups to support change management for the manufacturing process.
  • Generate study plans, protocols and summary reports to support the manufacturing process.
  • Establish and lead implementation of the continued process verification program to effectively manage product life cycles.
  • Adherence to highest standards for Compliance (Quality and Safety.)
  • Ensure compliance with site EHS policy, cGMP and other business regulations and participate in risk assessments, audits, regulatory inspections and incident investigations.
  • Actively participate in a culture of Continuous Improvement and process optimisation by deploying company Six Sigma tools.
  • Ensure the highest Quality, Compliance and Safety standards by participating and complying with our Manufacturing Division Quality Management System (QMS) requirements, including ownership, as relevant.

 

Minimum Qualifications and Experience:

  • BSc Degree in Biochemistry, Microbiology, Chemistry, Engineering or a related field.
  • 1-3 years’ experience in a pharmaceutical or a highly regulated environment preferably with cGMP experience.
  • Experience in at least two of the following areas protein chemistry, process engineering, cell culture, purification technologies, process operations, statistics, technology transfer, microbiological control of bio-manufacturing processes, cleaning validation, process validation, regulatory inspections.
  • Evidence of Continuous Professional Development and cross skilling.

 

11986 – Senior Process Engineer - Cork

Purpose:

The Senior Process Engineer will demonstrate a high level of innovation, enthusiasm and drive to deliver technical excellence for characterisation and optimisation of manufacturing processes and will be accountable for providing scientific and technical support to the operations team for effective and efficient running of all operations activities to a defined daily, weekly and monthly schedule as agreed with our customers. This requires a flexible, collaborative, and coaching style and will require a substantial amount of his/her time within the IPT process, engaging and communicating with all IPT members.

Responsibilities:

  • Provide Technical Support for the commissioning and qualification of the drug substance manufacturing process including equipment IOQ and PQ.
  • Support the facility start-up process by leading/participating in work groups to realise successful facility qualification and validation.
  • Work with site support groups to deliver qualified raw materials and consumables for the manufacturing process.
  • Support the technology transfer of drug substance manufacturing process through effective collaboration with business partners and customers.
  • Author, review and approve manufacturing documentation associated with transferred processes.
  • Troubleshoot manufacturing issues and lead investigations through scientific problem-solving approaches.
  • Partner with quality groups to support change management for the manufacturing process.
  • Generate study plans, protocols and summary reports to support the manufacturing process.
  • Lead and participate in process validation studies including but not limited to, cleaning studies, mixing studies and process characterisation studies.
  • Establish and lead implementation the continued process verification program to effectively manage product life cycles.
  • Adherence to highest standards for Compliance (Quality and Safety.)
  • Ensure compliance with site EHS policy, cGMP and other business regulations and participate in risk assessments, audits, regulatory inspections and incident investigations.
  • Actively participate in a culture of Continuous Improvement and process optimisation by deploying company Six Sigma tools.
  • Ensure the highest Quality, Compliance and Safety standards by participating and complying with our Manufacturing Division Quality Management System (QMS) requirements, including ownership, as relevant.

 

Minimum Qualifications and Experience:

  • BSc Degree in Biochemistry, Microbiology, Chemistry, Engineering or a related field.
  • 8-10+ years’ experience in a pharmaceutical or a highly regulated environment preferably with cGMP experience.
  • Experience in at least two of the following areas protein chemistry, process engineering, cell culture, purification technologies, process operations, statistics, technology transfer, microbiological control of bio-manufacturing processes, cleaning validation, process validation, regulatory inspections.
  • Evidence of Continuous Professional Development and cross skilling.

 

11970 – Facilities / Warehouse Project Delivery Engineer - Carlow

Purpose:

Reporting to the Facility & Warehouse Suite Lead, as part of a multi-discipline team, specifically responsible for assisting the Facility Suite Lead in the cost & schedule aspects of the Facility Suite scope. This candidate will be required to work closely with a cross-functional team & coordinate activities between Design, Construction, Process, Technical Operations, C&Q, IPT & QA.

Responsibilities:

  • Reporting to Facility Suite Lead.
  • Assist in the execution, of a schedule for the delivery of all aspects of the Suite scope.
  • Provide support for the administration, within a project charter, of the Facility Suite project execution within the overall capital project budget & schedule.
  • Develop, document, agree & implement an execution strategy to deliver the scope in a controlled & well communicated manner.
  • Coordinate the design effort with the contract engineering firm & ensure compliance to Local & Global standards.
  • Facilitate engineering & user requirements for the facility & warehouse systems e.g. Process Drains, Air Handling & Conditioning, Fire Protection, Cold Stores, Audio Visual etc.
  • Facilitate project specification processes with Design, construction contracting firms & end user.
  • Develop or contribute to the pertinent Mechanical/HVAC/Utility narratives for the project Design Manual & subsequent Design Reports.
  • Coordinate review of design material from the owner’s side including Layout reviews, P&ID/AF&ID reviews, Process Descriptions, Engineering Specifications, & PO’s/Data Sheets.
  • Assist in the assurance that project utilities designs are safe, constructible, operable, maintainable, economical, & compliant with regulatory requirements & authorized project scope.
  • Participate in Value Engineering.
  • Attend FATs when appropriate.
  • Review C&Q plans/protocols as related to Facility Suite systems.
  • Provide coordination expertise during C&Q activities as needed.
  • Assist in the coordinating of C&Q start-up activities, punch list follow-up.
  • Liaise with the various stakeholders on the overall project to ensure clear communication between all parties.
  • Facilitate/expedite Mechanical Completion in conjunction with the Construction team. (Liaise with construction contractors towards successful completion of Construction Turn Over Documentation.)
  • Coordinate third party vendors during SAT execution. Review & contribute to SAT protocols.
  • Attend daily communication meetings, as appropriate, with Facility Suite, Construction Management & Trade Partner teams, own assigned actions & report progress to completion.
  • Assist in investigations of process equipment, utility systems, & control system anomalies, as well as safety incidents.
  • Maintain a clean & safe working environment by enforcing procedures, policies & regulations.
  • Safety of all Facility & Warehouse Suite team members for the duration of the design, construct, commission validate & handover of the Facility Suite scope.
  • Support of the Facility Suite Lead in clear & documented methods.
  • Definition of scope & scope boundaries for all Suite related systems.
  • Delivery of the agreed milestones on the schedule within budget constraints.
  • Delivery of stakeholder agreed scope for Facility Suite facilities to Commissioning Qualification or as appropriate Process Qualifications.

 

 

Minimum Qualifications and Experience:

  • Bachelor of Engineering or Science Degree in Engineering or Technology related discipline.
  • Minimum of 8-10 years’ experience similar role in Pharmaceutical Facility/Building/Utilities systems within the Pharmaceutical industry.
  • Working knowledge of standards as they apply in biotechnology processes industries & a working knowledge of FDA & EU regulations is preferred.
  • The candidate will be a convincing communicator with strong interpersonal skills.
  • Knowledge of PIMS and EIDA an advantage.
  • Knowledge of Navisworks an advantage.
  • Knowledge of MS Teams an advantage.
  • Experience of design & construction/handover of pharmaceutical process & building facilities for pharmaceutical facilities.
  • Ability to work in a design & construction large project environment within Ireland.
  • Strong interpersonal & communication skills (verbal/written.)
  • Working knowledge of control systems & automation.
  • Working knowledge of C&Q documentation required for cGMP project delivery.
  • Fluent in English, written & verbal.
  • Ability to generate & communicate project plans & schedules.
  • Working knowledge of MS Office including word processing, spreadsheets etc., database management software, CAD software & PCs.

 

11969 – Process / Project Engineer - Carlow

Purpose:

Reporting to the Suite Team Lead, as part of a multi-discipline team, specifically responsible for assisting the lead in the cost, schedule and technical aspects of the Suite scope. This candidate will be required to work closely with a cross-functional team and coordinate activities between Design, Construction, Process, Technical Operations, C&Q, IPT and QA. Provide process engineering services in support of the design, construction, commissioning and qualification of a Sterile Formulation and Filling Facility.

Responsibilities:

  • Reporting to Suite Team Lead.
  • Assist in the development and delivery, within the overall project schedule, of a schedule for the delivery of all aspects of the Suite scope.
  • Provide support for the administration, within a project charter, of the Suite project execution within the overall capital project budget and schedule.
  • Develop, document, agree and implement an execution strategy to deliver the scope in a controlled and well communicated manner.
  • Coordinate the design effort with the contract engineering firm and ensure compliance to local & Global Standards.
  • Support cross-functional project teams to ensure project and site stakeholder inputs and requirements are clear and reflected in design deliverables.
  • Ensure all project stakeholders are informed and consulted on key process suite activities and decisions.
  • Monitor progress of process suite team milestones with all team members and provide status reports to project Tiers and stakeholders.
  • Assist in the assurance that project utilities designs are safe, constructible, operable, maintainable, economical, and compliant with regulatory requirements and authorized project scope.
  • Support GES Suite Leads and C&Q team to coordinate preparation and lead FATs/C&Q field execution.
  • Develop and/or review system lifecycle documents including Criticality and Risk assessments, FAT documentation, and C&Q documentation.
  • Support installation / start-up / testing of process systems through OQ completion. Interface with cross-functional team to ensure systems’ post-OQ (PQ, PPQ) readiness.
  • Provide coordination expertise during C&Q activities as needed.
  • Assist in the coordinating of C&Q start-up activities, punch list follow-up.
  • Liaise with the various stakeholders on the overall project to ensure clear communication between all parties.
  • Facilitate/expedite Mechanical Completion in conjunction with the Construction team. (Liaise with construction contractors towards successful completion of Construction Turn Over Documentation.)
  • Coordinate third party vendors during SAT execution. Review and contribute to SAT protocols.
  • Attend daily communication meetings, as appropriate, with suite teams and report progress.
  • Assist in investigations of process equipment, utility systems, and control system anomalies, as well as safety incidents.
  • Maintain a clean and safe working environment by enforcing procedures, policies, and regulations.
  • Safety of all suite team members for the duration of the design, construct, commission validate and handover of the suite scope.
  • Liaise with stakeholders, equipment vendors, business partners, and SMEs at other sites within the company’s Manufacturing Network as required to support Project.
  • Delivery of the agreed milestones on the schedule within budget constraints.
  • Delivery of stakeholder agreed scope for Suite facilities to Commissioning Qualification or as appropriate Process Qualifications.
  • The role will require periods of travel to support vendor reviews & FATs, and periodic attendance at Architect & Engineering Firm offices (Cork). Flexibility is required in this regard.

 

Minimum Qualifications and Experience:

  • Bachelor of Engineering or Science Degree in Engineering or Technology related discipline.
  • Minimum of 8-10 years’ experience similar role in Pharmaceutical Facility/ Building/Utilities systems within Pharmaceutical industry.
  • Working knowledge of standards as they apply in biotechnology processes industries and a working knowledge of FDA and EU regulations is preferred.
  • The candidate will be a convincing communicator with strong interpersonal skills.
  • Experience of design and construction/handover of pharmaceutical process and building facilities for pharmaceutical facilities.
  • Ability to work in design and construction large project environment within Ireland.
  • Strong interpersonal and communication skills (verbal/written.)
  • Working knowledge of control systems and automation.
  • Working knowledge of C&Q documentation required for cGMP project delivery.
  • Fluent in English, written and verbal.
  • Ability to generate and communicate project plans and schedules.
  • Working knowledge of word processing, spreadsheets, database management software, CAD software, and PCs.

 

11954 - QA IT Specialist - Cork

Purpose:

QA IT team provide independent compliance oversight and support for the site computerised systems. The successful candidate will join the team to support the implementation of a laboratory data management system and the pre-requisite upgrades of the computerised analytical instrumentation. The QA IT specialist will ensure the project is carried out in compliance with regulatory expectations and company Computer Systems Validation (CSV), System Development Lifecycle (SDLC), Cyber Security and Data Integrity requirements.

Responsibilities:

  • Providing independent quality review and approval of system lifecycle documentation, such as plans, requirements, risk assessments, test protocols and reports for new and modified systems.
  • Liaising with the global and the pilot site QA IT leads for the project to ensure that the system rollout on site follows the global VMP.
  • Providing independent quality review and approval of system changes.
  • Supporting and approving computerised systems investigations and deviations.
  • Ensuring consistent approach to qualification, change and deviation management.
  • Managing and prioritising day-to-day activities through active alignment with the project team, and supporting other areas as needed.
  • Providing timely and pro-active QA IT support and guidance to facilitate project timelines.
  • Where required, engaging with QA IT teams from other sites to standardise and align approach to computerised systems compliance.

 

Minimum Qualifications and Experience:

  • 8 years of experience in QA IT/CSV, CSV and/or a similar role in the pharmaceutical industry.
  • Expert knowledge of relevant regulations and industry standards.
  • Proven ability to meet timelines, prioritise tasks and engage with stakeholders.
  • Excellent communication skills.
  • Project management experience will be an advantage.
  • LabX experience will be an advantage.

 

11929 – Process Engineer - Carlow

Purpose:

Responsible for leading process and equipment investigations, authoring complex process deviations, Quality Notifications, driving continuous improvement initiatives, CAPA close out, IPT Standard Operating Procedures and Standard Work Instructions and change controls. Ensure that objectives are effectively achieved, consistent with the company’s requirements to ensure compliance, safety and reliable supply to our customers.

Responsibilities:

  • Investigate and author complex process deviations. Identify robust Corrective Actions and manage actions through to completion.
  • Lead multifunctional teams to complete improvement projects for IPT and actively participate, and lead, on-site Kaizen activities and investigations on behalf of IPT (e.g. Kaizen and investigation activities on processes and systems.)
  • Collaborate with IPT colleagues and non IPT colleagues, particularly Quality, EHS, Technical Engineering, in completion of tasks to ensure best practice outputs e.g. lead and in some cases partner with validation, maintenance and production operators in the investigation of complex equipment performance issues.
  • Work with coaches/engineers to apply lean tools to process data in order to complete process improvements e.g. KATA, SMED, standardized work etc.
  • Complete review, approval and close out of technical documentation including corrective actions, changes controls, and Technical Engineering protocols as required, in line with site standard approval process.
  • Identify, troubleshoot, investigate and remedy process and equipment issues and incidents, using Lean Six Sigma tools as applicable. Lead multifunctional root cause analysis investigations for equipment and process issues and incidents.
  • Complete process and equipment FMEA and change controls, ensuring action closeout.
  • Provide support with audit/inspection requirements to ensure department compliance/readiness.
  • Lead continuous improvement projects through the identification of CAPAs from system failure investigations and investigation reports.
  • Execution and development of change control, and lead Kaizen events as appropriate.
  • Lead complex multifunctional root cause analysis of system, process and equipment failures, using standard tools and methods, to resolve machine and system issues e.g. FMEA, Fishbone diagrams, 5 why’s etc.; oversee and implement subsequent corrective action, through the change management system.
  • Complete Customer complaint investigations and Change Controls and ensure they are closed out to support production activities in a timely manner in conjunction with the SCM team.
  • Required to comply with the company’s Global Policies, Procedures and Guidelines, regulatory requirements and execute current Good manufacturing Practices (cGMP) in the performance of day to day activities and all applicable job functions.
  • Work collaboratively to drive a safe and compliant culture in Carlow.
  • May be required to perform other duties as assigned.

 

Minimum Qualifications and Experience:

  • Bachelor’s Degree or Higher preferred; ideally in a Science, Engineering or other Technical discipline.
  • 3-5+ years’ experience required.
  • SAP knowledge and experience required.
  • Proficiency in Microsoft Office and job related computer applications required.
  • Knowledge of regulatory/code requirements to Irish, European and International Codes, Standards and Practices.
  • Report, standards, policy writing skills required.
  • Equipment and process validation.
  • Sterile filling processes and equipment.
  • Lean Six Sigma Methodology experience desired.
  • Strategy planning and development.
  • Demonstrable analytical and systematic problem solving skills.

 

11944 – Project Manager Non-IT – Remote / Carlow & Dublin

Purpose:

With your help we will ensure success by clearly defining and implementing an integration plan in alignment with our partners in Global L&D, HR, QA/QC and IT. For this role, you will work with the GL&D team, to develop and deploy the implementation project plan. You will ensure that the company’s core and common elements & standards are incorporated to ensure a single standard across all sites. You will work with the site team to develop the site L&D master plan in alignment with company principles and guidelines. This Project Manager will report to Global L&D lead and will collaborate with Global and County L&D, integration functional team leads and with other stakeholders as needed. This role can be worked remote but the candidate must be available for travel to Carlow and Dublin.

Responsibilities:

  • Conduct a current state assessment of the new site, complete gap assessment and develop a mitigation plan to align the new site to company processes.
  • Ensure a successful transition for learning systems, processes and procedures.
  • Collaborate with cross functional teams including, GL&D, HR, QA/QC and IT to ensure an integrated project plan.
  • Be responsible for implementing the process, toolkits /checklists, and schedule required by the team to actively carryout a successful integration.
  • Lead and develop core planning meetings, with the necessary agenda, input and outputs.
  • Liaise across the integration sub teams to develop plans with a medium to long -term forward view and associated daily delivery plans.

 

Minimum Qualifications and Experience:

  • B.S. in L&D, HR, Science, Computer Science or Project Management.
  • 8+ years of experience and knowledge in L&D, Org Design, Change Management HR.
  • Biologics manufacturing and new facilities start up preferred.
  • Demonstrated ability to manage multiple priorities against ambitious timelines. Strong planning ability.
  • Strong problem-solving skills and ability to work cross-functionally as critical member of site team.
  • Experience of working in a Project Management environment.
  • Good skills in understanding of non-functional requirements of a given functional area to be able to classify and have similar discussions related to.
  • Good attention to detail.
  • Should be proficient with MS Word/PowerPoint/Visio/Microsoft Project/Excel/Power BI to create data analytics, documents and presentations.
  • Experience working in teams.
  • Excellent communication skills (written & verbal-English.)
  • Solid interpersonal skills.
  • Solid collaborative skills, to be able to work in a diverse organisation.
  • Solid networking skills within peers and other work group.
  • Ability to manage broad range of stakeholders.
  • Exceptional communication skills and ability to communicate to multiple levels within company.

 

11442 – Validation Engineer - Carlow

Purpose:

As part of a significant expansion of the site, an exciting opportunity has come to join the Commercialisation team to transition from a project phase to a fully operational facility delivering life-saving products to patients. Within your chosen role you will be acting as a senior engineer reporting within the Technical Engineering department.

Responsibilities:

  • There are 4 broad technical areas that will require the leadership of experienced, energetic and committed engineers. The successful candidate will need to have demonstrated experience in one or more of these areas:
    • Sterilisation – Autoclaves, SIP of vessels.
    • Cleaning – Parts Washer and CIP of vessels.
    • Vial and Syringe filling operations –Glass handling, Tray & Tub handling, Drug Product Filling and Parenteral Product Visual Inspection.
    • Vial and Syringe Sterility operations – Isolators, VHP, E-Beam and Depyrogenation systems.
  • Each role will be involved in the project from the vendor Factory Acceptance Test (FAT), at the earliest, through to the Performance Qualification. Levels of responsibility will vary during this timeframe as outlined below:
    • Factory Acceptance Test – Attendance, hands-on support and C&Q Oversight.
    • Installation to Mechanically Complete – C&Q Oversight.
    • Commissioning & Qualification – Hands-on support & Oversight throughout project lifecycle.
    • Cycle Development – Execution of Cycle Development pre and post OQ phases.
    • Performance Qualification – Responsibility for / Execution of all Performance Qualification testing.
  • Engage in the early stages of the project, giving input into design by working with equipment vendors and global engineering teams, attending FAT and design reviews to represent client validation interests. Oversee equipment C&Q within the assigned area with a view to ensuring right first-time C&Q and Validation effort.
  • Act as validation SME on the equipment within the area assigned. As such you will be leveraging testing from Commissioning and Qualification.
  • Providing technical and validation oversight to process, design and project delivery teams and coaching to associate staff within the assigned suite.
  • Implementing the requirements as outlined in the site / project Validation Master Plan.
  • Coordination of engineering sub-teams in the assigned suite during execution of Cycle Development & Validation activities.
  • Authoring and reviewing standard operating procedures and technical reports including PQ protocols.
  • Technical review and approval of Commissioning protocols, Qualification protocols and Validation protocols executed by vendors, cross functional groups and/ or validation counterparts.
  • Supporting regulatory submissions as required.
  • Owning Change Management process for Equipment introduction within the assigned suite for qualification / validation up to PQ stage.
  • Effective application of LeanSixSigma and Change Management tools in the Validation group by:
    • Leading by example in achieving results by using industry standard tools and processes.
    • Facilitate problem solving & risk assessment (FMEA) projects/meeting.
    • Make problems visible and strive for continuous improvement.
    • Serving as a key member during internal audits and external inspections/audits.
    • Supporting alignment and knowledge exchange with development organizations, other commercial nodes and external manufacturing partners.
  • Lead and support various organizational initiatives as needed (examples include EHS, workload forecasting, work standardization, etc.)
  • Represent the site in internal collaborations through Manufacturing Division Validation Communities of Practice to include sharing of best practices in validation and investigation activities.
  • Keep up to date with scientific and technical developments, best practices and attend seminars as required.
  • Maintain continuous focus on quality and safety compliance and unflinching focus on the customer.
  • Execution in line with the site Continued Process Validation (CPV) program and supporting cross-site CPV as needed.

 

Minimum Qualifications and Experience:

  • Relevant technical qualification(s) in Applied Pharmaceutical / Biological / Computer / Chemical sciences or applied Technical / Engineering qualification.
  • This role requires an experienced individual with a minimum of 8 years directly related experience in academia, pharmaceutical or biotechnology industry – along with a working knowledge of current regulatory requirements and current Good Manufacturing Practices.
  • Minimum 6 years process equipment C&Q/ Validation experience on Large Scale Projects.
  • SME on Equipment Validation on any of; CIP & Parts Washer / SIP / Autoclaves / DHT & Electron Beam sterilisation / Vaporised Hydrogen Peroxide Sterilising Isolators / Clean Utilities Transfer Panels & Formulation Vessels.
  • Working knowledge of ASTM E2500 / Eudralex / FDA / ISPE guidelines.
  • Experience with liaising with other departments – engineering, technical, operations and QA.
  • Experience with sterile processing and sterilisation technologies.
  • Experience with cleaning and process validation, technology transfer, regulatory filing, and commercial drug product manufacturing of biologics is a plus.
  • Prior experience in drug product processing equipment, PQ, Process Performance Qualification and Validation, site readiness, batch record reviews, authoring documents subject to regulatory inspection.
  • SIP and CIP subject matter extensive experience.
  • Autoclave Qualification and Sterilisation Loads Cycle Development experience.
  • Use of temperature mapping equipment such as Lives/ Kaye etc. and trending, analysing and interpreting complex data.
  • Warehouse and CTU qualification.
  • A self-starter and results-focussed, the successful candidate will have strong contemporary knowledge, and the ability to work independently and on multidisciplinary teams.
  • The successful candidate will also have demonstrated the ability to deliver what is needed on-time, holding self and team members accountable for commitments, decisions, actions and behaviours.
  • Excellent oral and written communication skills, with the ability to effectively articulate understanding of process science, in order to drive decision making, impact assessments, design of studies, etc., in a multi-disciplinary team environment.
  • The candidate will also show ambition and drive to develop and advance within the role.
  • Desirable:
  • Visual Inspection technologies for Vial & Syringe.
  • Vial & Syringe processing technologies; drug product filling, glass handling, tray handling, stoppering, capping and CCI.
  • New facility brown/ green field facility experience.
  • Small equipment qualification and validation; FITs, Scales, Tube Sealers/ Welders, Headspace analysers, Flowmeters, Mobile Vessels & Single Use Technologies.
  • Project Management experience / training in use of Project Management tools.

 

11946 – Validation Engineer - Dublin

Purpose:

The Senior Specialist – Validation’s role will be essential in ensuring efficient and effective compliant design, construction, qualification, approval and operation of the new state-of-the-art facility during the initial project phase. The successful candidate will take a lead on utilising the latest innovations in technology and automation to create a workplace of the future.

Responsibilities:

  • Support the design, construction and qualification of the new Dublin facility and manufacturing science and technology laboratory by:
    • Developing and maintaining the site Validation Master Plan.
    • Driving completion of cleaning and sterilization cycle validation activities.
    • Support equipment qualification post Operational Qualification (OQ) through to Process Performance Qualification (PPQ) and revalidation.
    • Develop post OQ documentation in line with company and regulatory requirements.
    • Authoring and reviewing standard operating procedures and technical reports.
    • Supporting global regulatory submissions as needed.
    • Applying LeanSixSigma in the Validation group by:
      • Securing continuity of an appropriate LSS/CEM level of knowledge.
      • Facilitate problem solving & risk assessment (FMEA) projects/meetings.
      • Making problems visible and strive for continuous improvement.
      • Serving as a key member during internal audits and external inspections/audits.
      • Supporting alignment and knowledge exchange with development organizations, other commercial nodes and external manufacturing partners.
    • Lead and support various organizational initiatives as needed (examples include safety, financial forecasting, work standardization, etc.)
    • Represent the site in internal collaborations through the company’s Validation Communities of Practice to include sharing of best practices in validation and investigation activities.
    • Keep up to date with scientific and technical developments.
    • Maintain continuous focus on quality and safety compliance and unflinching focus on the customer.

 

Minimum Qualifications and Experience:

  • Bachelor’s degree (or higher) in Biological Sciences/Chemical Engineering/Biological Engineering/Chemistry (or PhD without industry experience.)
  • Minimum of 8 years’ (for BSc) directly related experience in academia, pharmaceutical or biotechnology company.
  • A working knowledge of current regulatory requirements and current Good Manufacturing Practices.
  • Strong contemporary knowledge.
  • The ability to effectively articulate understanding of process science, in order to drive decision making, impact assessments, design of studies, etc., in a multi-disciplinary team environment.
  • Experience with upstream cell culture and/or downstream purification of biological molecules.
  • Experience with technology transfer, regulatory filing, and commercial drug substance manufacturing of biologics is a plus.
  • Technical operations experience in the drug substance manufacture of biological molecules at the pilot- and/or commercial-scale.
  • Prior experience in drug substance, process performance qualification and validation, site readiness, batch record reviews, authoring regulatory CTD sections and/or working with external contract organisation for development and/or manufacturing.
  • Temperature Mapping Experience.
  • Cleaning Validation Experience.
  • Partswasher and Autoclave Experience.

 

11939 – Technical Specialist - Cork

Purpose:

As part of this 11 month contract role within the Technical Operations Centre of Excellence group, this position will provide validation support to a number of activities across the site. Successful candidate will report to the CQ&V Team Lead.

Responsibilities:

  • Participates in a compliant validation process for quality information technology and automation systems which require formal validation documentation under appropriate regulatory requirements and company manufacturing standards.
  • Prepares/reviews/approves validation documentation related to projects/change controls. (IQ, OQ, PQ.)
  • Participates in change controls and other compliance related tasks e.g. non-conformances.
  • Analyzes the results of testing and determines the acceptability of results against predetermined criteria.
  • Investigates and troubleshoots problems which occur and determines solutions or recommendations for changes and/or improvements.
  • Identifies current and anticipated requirements for compliant computerized operations and suggests methods for the identification, implementation, and maintenance of the procedures, actions, and documentation necessary to ensure compliance within the operation.
  • Coordinates with and guides other departments or outside contractors/vendors to complete validation tasks.
  • Supports regulatory audits and communicates company’s computer validation policies.
  • Investigates and troubleshoots problems which occur and determines solutions or recommendations for changes and/or improvements.
  • Works on own initiative to maintain adherence to schedule of activities.

 

Minimum Qualifications and Experience:

  • Degree in a suitable Science or Engineering discipline or other relevant discipline.
  • 3-4 years’ experience in a similar role.
  • Experience in a GMP environment essential.
  • Demonstrated knowledge in pharmaceutical / biopharmaceutical technical / manufacturing operations, with experience of successfully delivering technical projects.
  • Knowledge of Regulations and applicable standards for Quality, Safety, Regulatory.
  • Demonstrated knowledge in more than one pharmaceutical or Biopharmaceutical operation (e.g. manufacturing, technology, validation, engineering, quality, analytical.)
  • Demonstrated knowledge of Validation requirements within Biopharmacetical industry.
  • Demonstrated high level of problem solving and attention to detail.
  • Demonstrated capability of working and collaborating across multiple functional teams.
  • Demonstrated capability to deliver results RFT, in a FDA / HPRA Regulated production environment.

 

 

11936 – Compliance Specialist – Cork

Purpose:

The Compliance Specialist will work with the Integrated Process Team (IPT) compliance group, to maintain all aspects of compliance, within the Vaccine IPT team. This will require a substantial amount of his/her time engaging and communicating with all team members, within the various areas. The Compliance Specialist will promote a culture of compliance excellence at the facility, using a leadership style of collaboration and coaching.

Responsibilities:

  • Leads GEMBA walkdowns frequently, ensuring that areas are always audit ready.
  • Through collaborative and open dialogue, coach area owners in the compliance requirements.
  • Assist them in formulating corrective plans where required, putting a process in place, confirming that actions are addressed.
  • Ensures the highest Quality, Compliance and Safety standards.
  • Supports the Vaccine IPT compliance plan and generation of quality metrics.
  • Complete review and approval of IPT documentation.
  • Tracking and directing follow-up activities, to correct any non-conformity.
  • Leads GEMBA walk downs.
  • Participate in the preparation and hosting of regulatory and customer audits.
  • GMP training delivery to IPT personnel.
  • Investigation of Minor Deviations.
  • Provide Compliance guidance to Operating procedures.
  • Review Deviation Trends and identify effective CAPA’s, where necessary.
  • Member of the site Permanent Inspection Readiness (PIR) team, ensuring that the Vaccine IPT department is Permanently Inspection Ready.
  • Proactive monitoring of CAPAs, to ensure holistic trends are proactively resolved.
  • Participates in the overall CAPA effectiveness programme and continued improvement on root cause analysis and follow-up CAPA.
  • Participates in Quality Risk Management.
  • Optimises existing operations and practices with a focus on continuous improvement initiatives.

 

Minimum Qualifications and Experience:

  • 3rd Level Degree in Science/Engineering.
  • 3-5 years’ experience in Biopharmaceutical or Pharmaceutical industry.
  • >2 years’ experience in a Quality / Operations role.
  • Demonstrated technical knowledge and experience in compliance (GMP, Engineering, Technical.)
  • Desirable: Evidence of Continuous Professional Development.
  • Knowledge of and experience in applying Lean Six Sigma and Lean methodologies (e.g. 6S.)
  • Company and site quality policies, procedures and guidelines.
  • Relevant GMP standards.
  • The Quality System.
  • Site procedures and policies.
  • Understands key business drivers and uses this knowledge to make decisions and prioritise.
  • High level of skill in Technical Report writing.
  • Demonstrated ability to coach and influence others, within the Vaccine IPT.
  • Demonstrated ability to initiate and complete Continuous Improvement initiatives.
  • Leads Cross-Functional projects and initiatives, as assigned.
  • Demonstrated ability to identify issues and provide possible alternatives and solutions, both individually and working cross-functionally.
  • Good Organisation Skills. Ability to manage multiple priorities and to know when to escalate issues for resolution (time management.)
  • Proven ability to work as part of a highly motivated team.
  • Communication skills, both written and oral, including persuading others.
  • Good presentation skills. Advanced PC skills such as Excel, Word, PowerPoint.

 

11926 – Technical Specialist - Cork

Purpose:

This position will provide thermal mapping validation support to a number of activities across the site.

Responsibilities:

  • Preparation and review of Qualification protocols (IQ, OQ, PQ)
  • Preparation and review of Requalification protocols.
  • Execution of thermal mapping activities, including Controlled Temperature Units, Autoclaves, depyrogenation ovens.
  • Analyzes the results of testing and determines the acceptability of results against predetermined criteria.
  • Investigates and troubleshoots problems which occur and determines solutions or recommendations for changes and/or improvements.
  • Works on own initiative to maintain adherence to schedule of activities.

 

Minimum Qualifications and Experience:

  • Degree in an Engineering discipline or other relevant discipline.
  • Experience in a GMP environment essential.
  • 1-2 years’ experience in a similar role.
  • Use and operation of Kaye Validator 2000 data logger (or equivalent) is an advantage.
  • Demonstrated knowledge in pharmaceutical / biopharmaceutical technical / manufacturing operations, with experience of successfully delivering technical projects.
  • Knowledge of Regulations and applicable standards for Quality, Safety, Regulatory.
  • Demonstrated knowledge in more than one pharmaceutical or Biopharmaceutical operation (e.g. manufacturing, technology, validation, engineering, quality, analytical.)
  • Demonstrated knowledge of Validation requirements within Biopharmacetical industry.
  • Demonstrated high level of problem solving and attention to detail.
  • Demonstrated capability of working and collaborating across multiple functional teams.

 

11925 – QA Specialist - Tipperary

Purpose:

Associate Quality Specialist supports day to day QA activities in the facility. The Quality Specialist participates as a core member of the Process IPT (Integrated Process Team.)

Responsibilities:

  • Participate as functional expert in the cross functional team that manages production right first time at the site.
  • Review and approve batch, cleaning and testing documentation.
  • Ensure that all Laboratory Out of Specification (OOS) and process deviations are documented, assessed and associated CAPA identified.
  • Provide support to deviation investigations and process performance monitoring. Perform trending on deviations raised as required to identify improvement initiatives.
  • Provide detailed knowledge of quality systems in place and ensure that root cause is identified and corrective actions as appropriate are completed.
  • Provide guidance on quality requirements to maintain validation status, including participation in process/product Risk Assessments.
  • Provide feedback on re-occurring issues ensuring continuous improvement to systems/processes.
  • Ensure changes controls raised are documented, assessed and completed.
  • Prepare Annual Process and System Reviews.
  • Act as lead/team auditor to support the internal GMP walkdown and scheduled audits.
  • Participate in the generation and communication of quality metrics.
  • Creation, review and approval of quality procedures as required.

 

Minimum Qualifications and Experience:

  • Degree or post-graduate qualification in Science, Pharmacy or equivalent.
  • Knowledge of Quality IT systems desirable (e.g. SAP, Trackwise).
  • Spray drying experience desirable.
  • Knowledge and demonstrated expertise in Lean / Continuous Improvement.
  • Experience and knowledge of GMP Requirements for Electronic /paper free operations.
  • Experience in High potency manufacturing desirable.

 

 

11850 - Automation Project Manager - Laboratory Projects - Carlow

Purpose:

The Project Manager for labs will be responsible for delivery of Automation and IT scope on one or more lab projects in the portfolio of capital projects managed by Global Engineering Solutions (GES.) This candidate will be required to work closely with the wider project team and with vendors / partners and have responsibility for the full Automation and IT scope.

Responsibilities:

  • Partner with local project teams to deliver Automation and IT aspects of Laboratory capital projects.
  • Financial accountability for Automation / IT Spend (typically in the range of 4-8% of total capital cost.)
  • Ensure System Development Life Cycle (SDLC) deliverables, compliant with company standards.
  • Develop and execute project staffing plans.
  • Understand and educate local project teams on automation standards as they relate to technology selection, system configuration, SDLC, validation, hardware, software environments and business processes.
  • Work closely with the QAIT function to ensure compliance with company Quality standards.
  • Develop and\or provide input to the development of project schedules and document trackers.
  • Participate in, and support, relevant project meetings.
  • Support the development and execution of project staffing plans if required.
  • Drive efficiencies in execution of projects to reduce costs and cycle times based on standards.
  • Engages with stakeholders at all levels of projects.
  • Ensures that SDLC is appropriately applied.

 

Minimum Qualifications and Experience:

  • BS in Engineering, Computer Science, or other technical degree.
  • 7 or more years of experience in automation/IT support in a similar role with experience in laboratory analytical instrument qualification.
  • Excellent facilitation, problem solving, and decision-making skills.
  • Demonstrated ability to analyse and define business problems, develop business cases, and identify appropriate process and technological solutions is essential.
  • Proven facilitation, meeting/workshop management, project management and change management skills are essential.
  • Excellent written and oral communication skills, as well as strong presentation skills.
  • Experience with Laboratory systems such as LIMS, Empower and Nugenesis.
  • Experience in automation equipment used in Laboratory an advantage.

 

10339 - Process Engineer - Carlow

Purpose:

As part of this Technical Transfer Lead role you will be responsible for the transfer of a syringe product from the existing line to the newly expanded facility, and a formulation process from a US site to Carlow. As part of your role you will be leading a technical team to ensure that all aspects of the technical transfer process will be adhered to. As part of this role you will be the key point of contact on site for all aspects of the technical transfer which will require liaising with internal and external stakeholders. The role will be required for Q1 ’20 to help form the teams and build the technical transfer plan for the product. This will also ensure that process requirements will be embedded during the construction phase of the project (equipment and facility). Ultimately the Product and Process Qualification batches are planned mid 2022 with regulatory approval in 2023. Within this role you will be acting as the technical transfer lead for the syringe product, reporting within the Technical Engineering department.

Responsibilities:

  • Lead and execute process engineering activities to support the technical transfer of products to site. This includes but is not limited to: cycle development, Equipment PQ, PPQ’s, Cleaning, PCM, CTU mapping, filter validation, etc.
  • Plan, schedule and resource the complete technical transfer programme and then to lead the team to successful completion of the product introduction to regulatory approval and initiation of commercial production.
  • Engage in the early stages of the project, giving input into design by working with equipment vendors and global engineering teams to ensure that the process and product requirements are met.
  • Providing technical and product oversight to the process, design and project delivery teams and coaching to associate staff within the assigned suite.
  • You and your team will be required to Author and review procedures and technical reports required as part of the technical transfer.
  • You and your team will be Technical review and approval of Validation protocols executed by vendors, cross functional groups and/ or validation counterparts.
  • Supporting regulatory submissions, in particular driving the post approval change management process being adopted for this product.
  • Owning Change Management process for the product introduction.
  • Effective application of LeanSixSigma and Change Management tools by:
    • Leading by example in achieving results by using industry standard tools and processes.
    • Facilitate problem solving & risk assessment (FMEA) projects/meeting.
    • Make problems visible and strive for continuous improvement.
    • Serving as a key member during internal audits and external inspections/audits.
    • Supporting alignment and knowledge exchange with development organizations, other commercial nodes and external manufacturing partners.
  • Lead and support various organizational initiatives as needed (examples include EHS, workload forecasting, work standardization, etc.)
  • Represent the site in internal collaborations through Manufacturing Division Validation Communities of Practice to include sharing of best practices.
  • Keep up to date with scientific and technical developments, best practices and attend seminars as required.
  • Maintain continuous focus on quality and safety compliance and unflinching focus on the customer.

 

Minimum Qualifications and Experience:

  • Minimum of 10 years directly related experience in academia, pharmaceutical or biotechnology industry.
  • A working knowledge of current regulatory requirements and current Good Manufacturing Practices.
  • The successful candidate will also have demonstrated the ability to deliver what is needed on-time, holding self and team members accountable for commitments, decisions, actions and behaviours.
  • Excellent oral and written communication skills.
  • Ability to effectively articulate understanding of process science, in order to drive decision making, impact assessments, design of studies, etc., in a multi-disciplinary team environment.
  • Show ambition and drive to develop and advance within the role.
  • Process or technical transfer experience on Large Scale Projects.
  • Leadership experience managing a team to deliver short and long term objectives as part of a project or program.
  • Project Management experience / training in use of Project Management tools.
  • SME on Equipment within a sterile fill finish environment; e.g. CIP & Parts Washer / SIP / Autoclaves / DHT & Electron Beam sterilisation / Vaporised Hydrogen Peroxide Sterilising Isolators / Clean Utilities Transfer Panels & Formulation Vessels.
  • Working knowledge of ASTM E2500 / Eudralex / FDA / ISPE guidelines.
  • Experience with liaising with other departments – engineering, technical, operations, QA and Regulatory Affairs.
  • Experience with sterile processing and sterilisation technologies.
  • Experience with cleaning and process validation, technology transfer, regulatory filing, and commercial drug product manufacturing of biologics is a plus.
  • Prior experience in drug product processing equipment, PQ, Process Performance Qualification and Validation, site readiness, batch record reviews, authoring documents subject to regulatory inspection.
  • Desirable but not essential;
    • Visual Inspection technologies for Vial / Syringe.
    • Vial / Syringe processing technologies; drug product filling, glass handling, tray handling, stoppering, capping and CCI.
    • New facility brown/ green field facility experience.
    • Small equipment qualification and validation; FITs, Scales, Tube Sealers/ Welders, Headspace analysers, Flowmeters, Mobile Vessels & Single Use Technologies.

 

11870 – Process Engineer - Carlow

Purpose:

Provides leadership, cross-functional development and technical expertise to operations team on the aseptic manufacture of biologics and vaccines at the site. Ensure that objectives are effectively achieved, consistent with the company’s requirements to ensure compliance, safety and reliable supply to our customers.

Responsibilities:

  • Responsible for the coaching, mentoring and training of the operations teams on primary aseptic manufacturing, clean room management and behaviors within the site.
  • Assess the maturity of the teams aseptic and clean room ability; assess team member training/development needs and ensure all receive appropriate training, resources and programs to develop technical and other skills, to effectively complete their jobs. Develop and maintain training programs.
  • Assist the team with development of objectives and ensures alignment with site goals.
  • Foster an environment that allows for progressive, continuous improvement of skills and honest, open feedback focused on how/why to complete aseptic manufacturing process.
  • Provide ongoing formal and informal feedback on the aseptic qualification of the IPT operations team.
  • Oversee coordination of resources to implement suggestions/ideas of merit within the clean room areas.
  • Effectively lead the media fill (Process Simulation) development and execution.
  • Responsible for contributing to the Cleanroom Operation and contamination control procedures in IPT including but not limited to: Cleaning and Sanitisation, Garbing, People, Material and Process Flow, and Segregation Procedures.
  • Required to comply with company Global Policies, Procedures and Guidelines, regulatory requirements and execute current Good manufacturing Practices (cGMP) in the performance of day to day activities and all applicable job functions.
  • Work collaboratively to drive a safe and compliant culture in Carlow.
  • May be required to perform other duties as assigned.

 

Minimum Qualifications and Experience:

  • Bachelor’s Degree or higher preferred; ideally in a Science, Engineering or other Technical discipline.
  • Considerable experience and critical skills in their area of expertise that add value to the business; ideally in a manufacturing, preferably GMP setting.
  • Operational experience within high speed aseptic filling lines and formulations areas.
  • Knowledge of regulatory/code requirements to Irish, European and International Codes, Standards and Practices.
  • Sterile filling processes and equipment.
  • Pharmaceutical and Biotechnology manufacturing processes.
  • Proficiency in Microsoft Office and job related computer applications required.
  • SAP knowledge and experience preferred.
  • Lean Six Sigma Methodology experience desired.

 

 

11871 – Automation Engineer - Carlow

Purpose:

Senior OEM Engineer, reporting to the site AIT OEM Lead, specifically responsible for OEM Systems. This candidate will be required to work closely with the site AIT teams responsible for the full Automation and IT scope and with vendors / partners with responsibility for delivery of systems.

Responsibilities:

  • The Senior OEM engineer will be responsibility to the delivery, and qualification of OEM controls systems ensuing adherence to the all automation, quality and data integrity requirements.
  • Develop and/or review SDLC deliverables, compliant with company standards, including but not limited to:
    • Requirements Specifications.
    • Requirements Traceability Matrix.
    • Functional Specification.
    • Design Specification.
    • Code Review.
    • Test specification/test script.
  • Work closely with vendors of OEM equipment to ensure deliverables meet project requirements, including the interfacing of new OEM equipment with existing site systems, incl. MES and Pi Historian.
  • Work closely with the QAIT function and ensure their requirements are met in all deliverables.
  • Participate in Hardware and Software FATs and SATs.
  • Provide input to the development of project schedules and document trackers.
  • Participate in, and support, relevant project meetings.
  • Liaise with stakeholders on the overall project to ensure clear communication between all parties.
  • Required to comply with Global Policies, Procedures and Guidelines, regulatory requirements and execute current Good manufacturing Practices (cGMP) in the performance of day to day activities and all applicable job functions.

 

Minimum Qualifications and Experience:

  • Relevant Computer Science or Engineering degree or equivalent.
  • Minimum of 5 years’ experience in a similar role, ideally in the Pharmaceutical industry.
  • Fluent in English, written and verbal.
  • Strong experience in one or all of the following systems: Siemens PLCs, HMIs and Historian Software.
  • Excellent computer skills, proficient in the use of the following Microsoft tools: Excel, SharePoint, Word and PowerPoint.
  • Strong interpersonal and communication skills (verbal and written.)

 

11872 – Automation Engineer - Carlow

Purpose:

Reporting to the DeltaV Workstream Lead. The Automation Engineer will be responsible for the development of key documentation, test protocols, and for ensuing adherence GAMP practices. This candidate will be required to work closely with the site AIT teams responsible for the full Automation and IT scope and with vendors / partners with responsibility for delivery of systems.

Responsibilities:

  • The Senior DeltaV engineer will be responsibility to the delivery, and qualification of DeltaV Process Areas.
  • Be part of the DeltaV team contributing to the completion of a large-scale project.
  • Support the project on a day to day basis for the DeltaV System including: Design and test documentation generation, reviewing and approving.
  • Supporting of PLC system interfacing with the DCS system.
  • Design, Review, Approve SDLC deliverables, compliant with company standards, to ensure consistent implementation of the validation strategy, including but not limited to:
    • Requirements Specification.
    • Requirements Traceability Matrix.
    • Functional Specification.
    • Design Specification.
    • Code Review.
    • Test specification/test script.
  • Work closely with QAIT and ensure their requirements are met in all deliverables.
  • Participate in Hardware and Software FATs.
  • Provide input to the development of realistic project schedules and document trackers.
  • Work closely with suppliers / integrators to ensure compliance with company standards.
  • Participate in, and support, relevant project meetings.
  • Liaise with the various stakeholders on the overall project to ensure clear communication between all parties in relation to AIT validation requirements.
  • Required to comply with Global Policies, Procedures and Guidelines, regulatory requirements and execute current Good manufacturing Practices (cGMP) in the performance of day to day activities and all applicable job functions.

 

Minimum Qualifications and Experience:

  • Relevant Computer Science or Engineering degree or equivalent.
  • Minimum of 8 years’ experience in a similar role, ideally in the Pharmaceutical industry.
  • Fluent in English, written and verbal.
  • Working knowledge of GAMP5.
  • Excellent knowledge of DeltaV.
  • Knowledge of the following systems beneficial: PLC/SCADA and OSI PI.
  • Excellent computer skills, proficient in the use of the following Microsoft tools: Excel, SharePoint, Word and PowerPoint.
  • Strong interpersonal and communication skills (verbal and written.)

 

11586 – Electrical Instrumentation Engineer - Carlow

Purpose:

The Electrical & Instrumentation Engineer will perform an integral role in the development of company’s drug product facility. The Engineer will take ownership for the Electrical & Instrumentation systems on site (such as, but not limited to, MV/LV Systems, Instrumentation, E-Generator, UPS, Fire Detection, Access Control, CCTV, Automatic Doors, Lighting, E-Lighting and QBMS/NQBMS). Provide leadership, cross functional support and technical expertise to IUFT, maintenance and manage their operation through design, construction, validation, start-up and commercial manufacturing. Ensure that objectives are effectively achieved, consistent with the company’s requirements to ensure compliance, safety and reliable supply to our customers. The Electrical & Instrumentation Engineer will collaborate across functions, supporting, coaching and facilitating project sub-teams. Together, this dynamic group will meet the required project schedule milestones, in accordance with the applicable company standards for Quality and EHS compliance.

Responsibilities:

  • Responsible for delivery of schedule milestones throughout the project duration.
  • Collaborate and work cross functionally to develop and deliver on all aspects of the project through URS, FAT, SAT, IC, OC, IQ, OQ, PPQ and commercialization to meet schedule milestones.
  • Driving operational and technical excellence to deliver all components of a stable support utility (Electrical) equipment portfolio supporting PPQ, facility start-up and commercial supply, supported by a flexible, collaborative, multi-skilled teamwork environment.
  • Assist with the design and operationalisation of a successful IUFT that delivers right-first-time Electrical & Instrumentation equipment to achieve production requirements.
  • Resolve issues and escalate risks in a timely fashion to the relevant on-site stakeholders.
  • Comply with the current company’s Manufacturing Division, Quality and EHS Management System requirements, as relevant to the project and commercial operations.
  • Ensure that the IUFT team receive appropriate resources and programmes to develop technical and other skills, to complete their jobs whilst stimulating personal growth and development in line with role. Develop and maintain training programmes.
  • Drive effective writing/revising/ rolling out of accurate operational procedures, training materials and maintenance procedures for various IUFT systems; ensure all work is subsequently carried out in line with same.
  • Foster a culture of continuous improvement by deploying the company’s Six Sigma tools and support implementation of Model Area within operations from the start.
  • Expected travel – 20%

 

Minimum Qualifications and Experience:

  • Degree qualification or equivalent (Science, Engineering, Technical.)
  • 3 + years of related work experience in a GMP manufacturing environment or equivalent.
  • Expertise within electrical systems (MV & LV.)
  • Expertise of Instrumentation and control devices incld PLC control.
  • Experience of Laboratory Analytical equipment an advantage.
  • Experience of Utility systems an advantage.
  • Lean Six Sigma Methodology experience desired.
  • Evidence of continuous professional development is desirable.
  • Demonstrating energy and enthusiasm, the Electrical & Instrumentation Engineer, will be a role model for operational excellence, and will contribute to the organisation’s overall capability to thrive and grow.
  • Experience with GMP cleanroom facility commissioning and startup an advantage.
  • Demonstrated site operations project experience, from capital project to continuous support to manufacturing operations.
  • Proven track-record in delivering results in a world-class supply organisation.
  • A strong career history in pharma and familiarity with a highly regulated environment.
  • Innovative thinker, with excellent decision-making and problem-solving skills.
  • Experience of working in a cross functional environment.
  • Knowledge of and experience in applying Six Sigma and Lean methodologies.
  • Positive, flexible action-oriented attitude.
  • SME (subject matter expert) in Electrical & Instrumentation Engineer lifecycle (design, through to sustaining operations; including ARM – asset reliability maintenance.)
  • SME in Electrical & Instrumentation systems (such as, but not limited to, MV/LV Systems, Instrumentation, E-Generator, UPS, Fire Detection, Access Control, CCTV, Automatic Doors, Lighting, E-Lighting and QBMS/NQBMS.)
  • Knowledge of regulatory/code requirements to Irish, European and International Codes, Standards and Practices.
  • Report, standards, policy writing skills required.
  • Proficiency in Microsoft Office and job related computer applications required.
  • Lean Six Sigma Methodology experience desired.
  • Lead, promote, participate and supervise the implementation and maintenance of the relevant safety programmes.
  • Delivery of safety, performance and quality goals.

 

11845 – Automation Engineer - Cork

Purpose:

Reporting to the Project Lead, specifically responsible for MES Systems (Werum PasX.) This candidate will be required to work closely with the company teams responsible for the full Automation and IT scope and with vendors / partners with responsibility for delivery of systems.

Responsibilities:

  • Develop and/or review System Development Life Cycle (SDLC) deliverables, compliant with company standards.
  • Work with MES vendor in development of systems architecture, specifications, controls strategies, sequence of operations through all design stages.
  • Work closely with the QAIT function to ensure compliance with company Quality standards.
  • Participate in Hardware and Software FATs and SATs.
  • Provide input to the development of project schedules and document trackers.
  • Participate in, and support, relevant project meetings.
  • Liaise with stakeholders on the overall project to ensure clear communication between all parties.
  • Required to comply with Global Policies, Procedures and Guidelines, regulatory requirements and execute current Good manufacturing Practices (cGMP) in the performance of day to day activities and all applicable job functions.

 

Minimum Qualifications and Experience:

  • Bachelor’s Degree in Engineering, Information Systems, Computer Science or the Life Sciences.
  • Minimum of 3 years’ experience in a similar role, ideally in the Pharmaceutical industry.
  • Fluent in English, written and verbal.
  • Experience in the commissioning of MES on site in a GMP manufacturing environment.
  • Technical proficiency on controls systems including familiarity with control panels, networking, panel/field wiring and PLC control systems.
  • Excellent computer skills, proficient in the use of the following Microsoft tools: Excel, SharePoint, Word and PowerPoint.
  • Strong interpersonal and communication skills (verbal and written).

 

11837 – C&Q Engineer - Cork

Purpose:

Reporting to C&Q Technical lead as part of a multi-discipline team responsible for Commissioning & Qualification (C&Q) activities on a Drug Product facility. The candidate will be a convincing communicator with strong interpersonal skills. This candidate will be required to work closely with a cross-functional team and coordinate activities between Construction, Process, Technical Operations, IPT and QA.

Responsibilities:

  • Report to C&Q Technical Lead on the project.
  • Support a suite team during a commissioning and qualification program.
  • Assist the C&Q Technical Lead in the planning and tracking of activities.
  • Liaise with the various stakeholders on the C&Q team and the overall project to ensure clear communication between all parties.
  • Participation in GMP design reviews (DQ, CIA etc) as required.
  • Review and Input into deliverables such as technical requirement specifications and vendor turnover documentation.
  • Participate in C&Q deliverables (System Impact Assessment, Critical Component Impact Assessments, System Boundary Drawings, Requirement Traceability Matrix.)
  • Participate in generation, execution and approval of C&Q documentation (FAT, SAT, IOC, DQ, IQ, OQ, IOQ) for the project based on available approved client templates & design documentation.
  • Review of CCRs and TOPs. May require travel to vendor shops and frequent communication with vendors to ensure documentation deliverables are per the VDRs.
  • Participate in C&Q change controls (FDCNs and PCNs) and drive their closure in a timely manner. Ensure non-conformances & deviations are minimised and closed out in a timely fashion.
  • Responsibility for direct supervision of vendor engineers and contractors during C&Q activities.
  • Manage the site attendance for the vendors, contractors and specialist contractors.
  • Confirm all vendor documentation executions are compliant with GxP practices & the executed documentation is acceptable to support C&Q.
  • Perform system P&ID walkdown with construction prior to handover. Categorisation of punchlist items & tracking to completion.
  • Support review on all Isometrics, Weld logs, Weld Qualifications, 3rd Party Inspections, Material of Construction and Redlining exercise.
  • Confirm the site installation is as per approved design specification and meet system IQ requirements.
  • Facilitate/expedite Mechanical Completion in conjunction with the Construction team. (Liaise with construction contractors towards successful completion of Construction Turn Over Documentation.)
  • Generate method statements, risk assessments & permit preparation for responsible areas from M/C to handover to site operations.
  • Pre-start up safety checks, LOTO & ensuring timely loop checking and calibrations.
  • Coordinate and supervise third party vendors during SAT execution. Review and approve SAT protocols.
  • Attend daily communication meetings with suite team and report progress.
  • Assist in investigations of process equipment, utility systems, and control system anomalies, as well as safety incidents.
  • Maintain a clean and safe working environment by enforcing procedures, policies, and regulations.
  • Implement the company’s GES C&Q strategies as set out by the C&Q Technical Lead.
  • Ensure that system delivery progresses in accordance with the approved project schedule.
  • Notify C&Q Technical Lead, in a timely manner, of all relevant issues which may impact on system progress.
  • Ability to work in design and construction project environment within Ireland.
  • Coordinate with design and/or project teams to resolve any identified technical issues.
  • Organise/attend all coordination meetings necessary to progress the job. Possess good communication skills.
  • Ensure that all works carried out in C&Q scope or responsibility by construction, commissioning and contract team members are performed in accordance with site safe working practices.

 

Minimum Qualifications and Experience:

  • Bachelor of Engineering or Science Degree in Engineering or Technology related discipline.
  • Minimum of 10 years’ experience in commissioning and / or validation of Drug Product Facilities/Utilities systems within Pharmaceutical industry.
  • Technical knowledge of black utilities and clean utilities systems and equipment, biotechnology processes and a working knowledge of FDA and EU regulations is preferred.
  • Experience in C&Q of Drug Product Facility.
  • Working knowledge of process control systems and automation. DeltaV, syringe & vial line experience beneficial.
  • Knowledge of C&Q documentation required for cGMP process equipment.
  • Fluent in English, written and verbal.
  • Ability to understand project plans and schedules.
  • Working knowledge of word processing, spreadsheets, database management software, CAD software, and PCs.
  • Knowledge of regulations and standards affecting devices, biologics and pharma products.
  • Knowledgeable with latest industry standards and guidelines on C&Q, including ISPE/ASTM.
  • Strong interpersonal and communication skills (verbal/written.)

 

10478143 - Process Development Scientist - Dublin

Purpose:

The Senior Specialist Technical Services has primary responsibility for providing technical support of commercial and clinical drug substance and drug product manufacturing operations performed at contract manufacturing organisations (CMOs). The successful candidate will be responsible for providing scientific and engineering support through all phases of the product lifecycle, including technology transfer, process scale-up, process validation and routine commercial or clinical manufacturing. The position requires effective cross-functional collaboration with external contractors and internal partners including Manufacturing, Process Development, Engineering, and Quality to provide support of manufacturing.

Responsibilities:

  • Provide significant technical expertise to support all aspects of the manufacturing of commercial and late stage clinical biopharmaceutical products at CMOs or internally.
  • Lead troubleshooting efforts and high-level deviation investigations in conjunction with CMOs and internal partners (Process Development, Manufacturing, Quality, etc.)
  • Support all aspects of the manufacturing process from raw material selection and specification through upstream manufacture, downstream processing, testing and release.
  • Technical review of change controls for impact to product quality, safety and efficacy.
  • Provide on-floor technical support and troubleshooting at the CMO facility if required.
  • Provide technical oversight and direction for transferring new products and processes to commercial CMO sites.
  • Identify and lead process optimization initiatives and address opportunities for efficiency and capacity improvements in all areas of manufacturing.
  • Technical protocol and summary report generation as related to technical studies executed in direct support of GMP manufacturing activities.
  • Collection, organisation, trending, and analysis of GMP manufacturing data.
  • Identify manufacturing best practices across the network and lead or participate in teams to implement best practices.
  • Support establishment of validation plans and evaluation of drug substance/product production site options.
  • Provide SME input for IND, BLA and other technical documents for regulatory agency submission in support of manufacturing process operated at CMOs.
  • Up to 20% international travel required.

 

Minimum Qualifications and Experience:

  • Minimum BS degree in Scientific (Biochemistry, Biology, Chemistry) or Engineering (Chemical, Mechanical) related field. Advanced degree would be an advantage.
  • Minimum of five years’ experience in providing technical support to biologics drug substance manufacturing or a strong operations role.
  • Extensive knowledge of biologics manufacture, mammalian cell culture and purification unit operations.
  • Comprehensive understanding of cGMP requirements for clinical and commercial biopharmaceutical manufacturing.
  • Ability to present and defend technical aspects of manufacturing operations during regulatory agency inspections.
  • Experience of technology transfers and scale-up.
  • Experience of working with CMOs would be a distinct advantage, demonstrating strong communication and influencing skills.

 

11781 - Automation Engineer – Tipperary

Purpose:

Reporting to the Project Lead, specifically responsible for DeltaV Systems. This candidate will be required to work closely with the teams responsible for the full Automation and IT scope and with vendors / partners with responsibility for delivery of systems.

Responsibilities:

  • Develop and/or review System Development Life Cycle (SDLC) deliverables, compliant with company standards.
  • Work with DeltaV vendor in development of systems architecture, specifications, controls strategies, sequence of operations through all design stages.
  • Work closely with the QAIT function to ensure compliance with company Quality standards.
  • Participate in Hardware and Software FATs and SATs.
  • Provide input to the development of project schedules and document trackers.
  • Participate in, and support, relevant project meetings.
  • Liaise with stakeholders on the overall project to ensure clear communication between all parties.
  • Required to comply with Global Policies, Procedures and Guidelines, regulatory requirements and execute current Good manufacturing Practices (cGMP) in the performance of day to day activities and all applicable job functions.

 

Minimum Qualifications and Experience:

  • Bachelor’s Degree in Engineering, Information Systems, Computer Science or the Life Sciences.
  • Minimum of 8 years’ experience in a similar role, ideally in the Pharmaceutical industry.
  • Experience in the commissioning of DeltaV site at a GMP manufacturing site.
  • Technical proficiency on controls systems including familiarity with control panels, networking, panel/field wiring and PLC control systems.
  • Excellent computer skills, proficient in the use of the following Microsoft tools: Excel, SharePoint, Word and PowerPoint.
  • Strong interpersonal and communication skills (verbal and written.)
  • Fluent in English, written and verbal.

 

10497462 – Technical Services Specialist - Dublin

Purpose:

The Cell Culture Specialist Technical Services has primary responsibility for providing scientific & technical support of (cell culture derived) drug substance manufacturing processes performed at the facility. The successful candidate will be responsible for providing scientific and technical support through all phases of the product lifecycle, including technology transfer, process scale-up, process validation, routine manufacturing, and process/continual improvement programs. The position requires effective cross-functional collaboration with external contractors and internal partners including Manufacturing, Process Development, Engineering, Regulatory, QC and Quality to provide support of manufacturing of BDS.

Responsibilities:

  • Provide process information and expertise to facilitate process/facility fit, and qualification of a large scale BDS facility through to NPI tech transfer startup, PPQ validation, launch and continual improvement of existing and future products in a multi-product BDS facility.
  • Provide technical direction and provide SME oversight in an area of BDS manufacturing; (mammalian cell culture/downstream purification), be the company’s SME (Cell Culture) to develop and defend technical rationale during regulatory audits and inspections.
  • Provide scientific and technical input to facilitate decision making.
  • Provide input and engage with Product Lifecycle Management (PLCM) of company products.
  • Identify technical issues, improvement initiatives and guide resolution/completion of same.
  • Possess deep technical knowledge and understanding in BDS manufacturing processes; (mammalian cell culture/ downstream purification operations, cause and effect, scale up principles, QRM, process validation strategies) and apply and build on the company’s product portfolio.
  • Shape and develop strategy approaches for Technical Services in areas such as Mammalian Cell Culture technologies, downstream purification technologies, Technology Transfer, PPQ, CPV approach and so forth, maintaining industry trends and advances.
  • Ensure current with Regulatory frameworks/changes, and industry trends, ensuring robust and scientifically sound rationale and justifications are embedded into the company’s Technical and Manufacturing strategies.
  • Collaborate to influence the design and implementation robust process control strategies, process risk assessments and associated documentation to support equipment qualification activities, PPQ studies, and key technical strategies supporting process improvements for yield increases and improvement of manufacturing robustness.
  • Develop and update predicator modelling, and the use of data monitoring systems to identify trends.
  • Be a QRM Risk facilitator/mentor for others, aligning approaches to risk assessment per company procedures.
  • Provide Technical input, review/approval into documentation associated with materials, manufacturing control and enterprises systems (MCS/MES) including manufacturing and technical documentation.
  • Ongoing Subject Matter Expert technical support to Technical Services and Manufacturing Operations by providing technical expertise for investigation and resolution for process deviations, CAPAs, change controls.
  • May be required to work periodically out of normal business hours (temporary shift working or per out of hours policy) during periods of engineering and validation batch execution, as well as any other duties as required.
  • Author, review and approval of reports in support CMC sections of regulatory agency submissions and responses (as required.)
  • Contribute to successful regulatory agency inspections by providing subject-matter expertise on mammalian cell culture/downstream purification, technology transfer and manufacturing processes.

 

Minimum Qualifications and Experience:

  • Minimum undergraduate degree in chemistry, biology, engineering or related discipline.
  • An advanced degree (MS, PhD) in Scientific (Biochemistry, Biology, Chemistry, Pharmacy) or Engineering (Chemical, Mechanical) related field is desirable.
  • 8 years+ experience in a pharmaceutical manufacturing organization. Bulk Drug Substance manufacturing, with previous experience in cell culture unit operations, process/facility fit, New Product Introduction Technology Transfer.
  • In-depth technical & operational knowledge of unit operations in cell culture processing, centrifugation, depth filtration. Understanding of cause and effect of cell culture metabolism.
  • Strong understanding of analytical methods and corresponding signals to enable control strategy development and improvement. Strong understanding of technology transfer, bioreactor scale-up process and scaling principles.
  • Comprehensive understanding of cGMP requirements for biopharmaceutical manufacturing and the ability to implement best practices to ensure multi-product bulk drug manufacturing operations are cGMP compliant.
  • Experience of Validation / Verification of GMP equipment or processes would be beneficial.
  • Experience of process/facility fit, design, commissioning and start-up of a bulk drug substance facility is beneficial.
  • Engage in continual improvement through assessment and use of new PAT technologies, by design of scientifically robust assessment protocols and study design.
  • Good interpersonal skills coupled with demonstrated ability to effectively work in a cross-functional global environment matrix organization, and in local group settings.
  • Ability to develop, build, present and defend technical and scientific approaches in both written and verbal form.
  • Can effectively partner with and influence stakeholders without direct solid line authority.
  • Drives technical decisions balancing product quality and operational requirements.
  • Ability to drive for results independently and adapt to rapidly changing priorities.
  • Experience of Technology Transfer and post launch process improvements.
  • Knowledge or experience of start-up or systems would be ideal.
  • Excellent communication skills, and able to effectively influence across all levels of the organization both internal and external to the company.
  • Detail orientated, technical writing competency.
  • Excellent organizational skills with strategic thinking and vision for Technical Services at the company.
  • Demonstrated ability to drive for results and lead innovation and change.
  • Self-driven, able to prioritize, and to orchestrate multiple activities at once.
  • Ability to deal with ambiguity and complexity and influence others across levels of the organization.

 

11731 – QA Compliance Specialist - Dublin

Purpose:

The Compliance Specialist will support GMP and inspection readiness activities and as required collaborate with the Internal Audit team. Candidate will ensure that objectives are effectively achieved, consistent with the company’s requirements to ensure compliance, safety and reliable supply to our customers. This role will report to the Site Lead Auditor.

Responsibilities:

  • Provide Quality and cGMP input and oversight for GMP readiness activities.
  • Review and approval of pre executed and post executed protocols.
  • Review of technical support documentation.
  • Review of functional area documentation (SOPs, Work Instructions, technical reports and protocols.)
  • Provide support for internal audit and inspection readiness activities.

 

Minimum Qualifications and Experience:

  • Degree in natural or applied sciences (Pharmacy, Biology, Biotechnology, Engineering.)
  • Minimum 5 years pharmaceutical and/or biotech industry experience in Quality/ Compliance related role.
  • Experience in startup facilities a distinct advantage.
  • Demonstrated problem solving capabilities.
  • Sound awareness and understanding of pharmaceutical business, especially with regards to quality and regulatory requirements.
  • Ability to operate efficiently in a complex matrix organization and global environment.
  • Ability to self-motivate and work independently and as a team.
  • Strong leadership and interpersonal influencing skills.
  • Strong verbal and written communication skills with well-structured communication and presentation ability to various audience levels.
  • English fluency written and spoken (the Company language.)
  • Experience in Trackwise and SAP an advantage.

 

11778 – CSV Engineer For Labs - Carlow

Purpose:

The Engineer for labs will be responsible for delivery of Automation and IT scope on one or more lab projects in the portfolio of capital projects managed by Global Engineering Solutions (GES.) This candidate will be required to work closely with the teams responsible for the full Automation and IT scope and with vendors / partners with responsibility for delivery of systems.

Responsibilities:

  • Partner with local project teams to deliver Automation and IT aspects of Laboratory capital projects.
  • Develop and/or review System Development Life Cycle (SDLC) deliverables, compliant with company standards.
  • Coach, mentor and provide technical training to colleagues.
  • Understand and educate local project teams on automation standards as they relate to technology selection, system configuration, SDLC, validation, hardware, software environments and business processes.
  • Work closely with the QAIT function to ensure compliance with company Quality standards.
  • Provide input to the development of project schedules and document trackers.
  • Participate in, and support, relevant project meetings.
  • Support the development and execution of project staffing plans if required.
  • Drive efficiencies in execution of projects to reduce costs and cycle times based on standards.
  • Engages with stakeholders at all levels of projects.
  • Ensures that SDLC is appropriately applied.

 

Minimum Qualifications and Experience:

  • BS in Engineering, Computer Science, or other technical degree.
  • 8 or more years of experience in project/automation/IT support in a similar role with experience in laboratory analytical instrument qualification.
  • Excellent facilitation, problem solving, and decision-making skills.
  • Demonstrated ability to analyse and define business problems, develop business cases, and identify appropriate process and technological solutions is essential.
  • Proven facilitation, meeting/workshop management, project management and change management skills are essential.
  • Excellent written and oral communication skills, as well as strong presentation skills.
  • Experience with Laboratory systems such as LIMS, Empower and Nugenesis.
  • Experience in automation equipment used in Laboratory an advantage.

 

11755 – Project Manager NON-IT - Cork

Purpose:

GES manages significant capital projects worldwide for the company across manufacturing and research divisions and across different lines of business including Animal Health, Human Health, Sterile, Biologics, Pharmaceutical, Chem API at the various manufacturing sites. For the site in Cork the focus is on Sterile, Biologics & Vaccines. We are seeking applications for the position of a GES Project Engineer for an 11 month assignment. This is a good opportunity to be involved with a portfolio of projects providing guidance and engineering oversight. This position reports to the Associate Director (AD), GES OEP Lead at the Cork site. In summary, the Project Engineer will work within the Global Engineering Solutions (GES) team to direct the activities of the sites Outsourced Engineering Provider (OEP), Project Management Group, in the implementation of assigned capital and expense projects. They will play a key role in development and management of the OEP Project Portfolio and lead improvement initiatives related to the execution of capital projects. The Project Engineer could also be assigned to work on larger capital projects if required.

Responsibilities:

  • Providing assistance to the AD to manage the projects portfolio at the site using the OEP model while meeting business objectives.
  • Provide management and leadership to ensure that the OEP (Outsourced Engineering Provider) model at the site is best in class delivering small-to-medium and complex projects safely within budget and on schedule meeting the business needs.
  • Ensure there is a strong safety culture covering both process and construction safety performance in the execution of site small-medium capital projects.
  • Working with the OEP team ensure that there are resources and execution strategies in place to execute the portfolio of projects successfully and that there is an effective governance structure to manage and report on portfolio performance.
  • Ensure that there are clear project plans for the portfolio of projects and that design, construction, commissioning & qualification, schedule and cost are effectively managed.
  • Acts as a liason with the GES Tech Center to ensure required project checklists / reviews are being carried out on OEP projects.
  • Provides up-to-date information on the status of capital and expense projects including budget/expenditure and schedule details, including monthly and quarterly accruals and spend forecasts on portfolio projects.
  • Deputises for the site GES OEP Capital Projects Lead as required.

 

Minimum Qualifications and Experience:

  • A 3rd level qualification in Chemical, Mechanical, Electrical or related discipline.
  • Preferable to have a minimum of 10 years experience in an engineering environment, preferably in a strongly regulated GMP environment.
  • Strong interpersonal skills with an understanding of the customer relationship, capable of dealing with site senior stakeholders, and with the management of engineering companies required for successful completion of a portfolio of small projects.
  • Understands the typical project life cycle from concept through to qualification and has proven experience in these areas on small-medium projects.
  • Demonstrated experience in portfolio management.
  • Technical knowledge of equipment and buildings design and qualification, preferably within the Sterile, Biologics & Vaccines business areas. This requires a working knowledge of both regulatory and corporate requirements for equipment qualification and process safety requirements including Process Safety Management (PSM) such as HAZOP’s, pressure relief and risk assessments.

 

2020-333 – Controls Engineer - Waterford

Purpose:

The Controls Engineer will execute projects in a fast paced, multi-disciplined, cross-functional team environment.

Responsibilities:

  • Manage production and the introduction of new technology through team leadership.
  • Provide technical and vision core competency support to Global Operations and Engineering on an as-needed basis, including possible off-hours, remote and onsite coverage rotation.
  • Provide Technical support and technical reference expertise to manufacturing and outside vendors in developing technical solutions for vision inspection technologies.
  • Project Management/ support of capital projects within the Waterford Plant to drive increased volume and decreased cost across multiple manufacturing processes.
  • Provide Technical specification documents to external vendors for the purpose of trending and design/ build of new manufacturing equipment.
  • Support product, platform and cost improvement programs by delivering qualified vision systems. Interface with Engineering, SQA, QA and Operations to successfully validate software systems. Author and execute associated validation documents.
  • Provide technical and operations training on systems delivered.
  • Travel to vendor and B+L locations for on-site project support (domestic & international.)
  • Vendor management.
  • Deliver projects on time and within budget.

 

Minimum Qualifications and Experience:

  • Electronics/ Electrical Engineering qualification.
  • 3 – 5 years relevant experience.
  • Computer/Software development systems.
  • PLC- Allen Bradley, Siemens.
  • High Level language Programming e.g. C#, VB.net.
  • Practical knowledge of machine vision systems including Cognex VPro and InSight desired.
  • Methodical/Analytical approach to problem solving.
  • FDA regulated Medical Device.
  • Project Management.
  • PLC Software Development.
  • Scada Software development.
  • Manufacturing support.
  • Development, documentation and approval of technical documentation.

 

2020-332 – Production Manager – Waterford City

Purpose:

A production manager is involved with the planning, coordination and control of manufacturing processes. They ensure that goods and services are produced efficiently and that the correct amount is produced at the right cost and level of quality.

Responsibilities:

  • Manage FILM production and the introduction of new technology through team leadership.
  • Conduct Standard Work for managers. Monitor standard work for OSS /Team Leads and operators.
  • Train and Participate in work place innovation, Align to tier management system.
  • Responsible for the production activities including, PPI, Yields, Downtime, Quality Metrics and the utilization of machinery & human resources.
  • Initiate changes to work practices and procedures.
  • Provide a high level of technical competence and leadership to the shift to ensure that operational issues are identified and managed to achieve challenging KPI’s and higher operational performance.
  • Promotion of decision making at operative & technician level through effective development and fostering of a strong team working culture.
  • Promote a quality culture and act to ensure compliance with all regulatory requirements including FDA and cGMP.
  • Conduct and manage performance appraisals for operators and identify and implement appropriate training & development plans.
  • Execute communications within the unit and to other departments within the company.
  • Plan and manage team members attendance, timekeeping.
  • Establish and maintain high standards in relation to Environmental Health & Safety work practice.
  • Meet budgetary targets set in relation to output and spend.
  • Key cGMP Responsibilities:
    • Ensure compliance with manufacturing SOPs, Gowning up and other PPE policies, hygiene and EHS procedures at all times.
    • Participate fully in all GMP training programs as identified and complete all Training Records in an accurate and timely manner.

 

Minimum Qualifications and Experience:

  • 3rd level qualification, preferably in a technical discipline desirable.
  • Previous supervisory management experience in a manufacturing environment complying with FDA, cGMP requirements is essential (unionized environments preferred.)
  • Advanced leadership skills to build and motivate the process team by providing clear direction and facilitation.
  • Knowledge of FILM operation desirable.
  • A successful track record in managing conflict resolution.

 

10872 – Equipment Engineer - Dublin

Purpose:

The role will report to the Upstream or Downstream Equipment Manager.

Responsibilities:

  • Ensure compliance to all regulatory GMP, Safety and Environmental requirements.
  • Support Commissioning and Qualification activities and lead troubleshooting efforts.
  • Support site start-up activities.
  • Collect data and develop maintenance job plans for equipment and systems.
  • Develop SOP’s and Work Instructions for Maintenance of Equipment.
  • Develop Safety Risk Assessment.
  • Participate in FMEA exercises with support from other functions. Document results and input data into appropriate repositories – make recommendations for improvements.
  • Optimise work tasks, collect spare parts, tools or other services requirements.
  • Liaising with project hand over team to ensure that the correct information is captured.
  • Assist with development of Technical Training Materials.
  • Running applicable reports and pulling documents together for meetings and audits.
  • Support Quality, Safety and Environmental Investigations.

 

Minimum Qualifications and Experience:

  • Level 8 Qualification in Engineering discipline or equivalent.
  • 4+ years’ experience in a process plant or other industry in a maintenance or operations support role.
  • Strong communications, organizational and analytical skills.
  • Experience of reading P&IDs, Construction and Mechanical / Electrical Drawings.
  • Desirable:
  • Experience of using SAP or Other Computerised Maintenance Systems.
  • Experience of developing Safety Risk Assessments.
  • Previous experience of FMEA’s – setting up maintenance plans and schedules.

 

 

9934 – Process Engineer - Carlow

Purpose:

An exciting opportunity has come to join the Commercialisation team to transition from a project phase to a fully operational facility delivering life-saving products to patients. There are 4 broad technical areas that will require the leadership of experienced, energetic and committed engineers – (1) Sterilisation – Autoclaves, SIP of vessels (2) Cleaning – Parts Washer and CIP of vessels (3) Vial and Syringe filling operations –Glass handling, Tray & Tub handling, Drug Product Filling and Parenteral Product Visual Inspection. (4) Vial and Syringe Sterility operations – Isolators, VHP, E-Beam and Depyrogenation systems. The successful candidate will need to have demonstrated experience in one or more of these areas.

Responsibilities:

  • Responsible for introducing new processes and/or products (product transfer.)
  • Develop and transfer knowledge of Lean Six Sigma, Change Management and Inclusion.
  • Steer and/or participate in cross-functional investigations on problems/deviations – including defining corrective and preventive actions.
  • Identify, analyze and prioritize technical or business related processes improvement-opportunities and problems.
  • Initiate and coordinate improvements for technical or business processes, systems and behaviors.
  • Contribute to a data driven decision making process, Ensure effective application of LeanSixSigma and Change Management tools by leading projects, facilitating kaizens and coaching sponsors and practitioners.
  • Works with moderate work direction and is skilled and knowledgeable to the position.
  • Engage in the early stages of the project, giving input into design by working with equipment vendors and global engineering teams, attending FAT and design reviews to represent client validation interests. Oversee equipment C&Q within the assigned area with a view to ensuring right first-time C&Q and Validation effort.
  • Act as validation SME on the equipment within the area assigned. As such you will be leveraging testing from Commissioning and Qualification.
  • Providing technical and validation oversight to process, design and project delivery teams and coaching to associate staff within the assigned suite.
  • Implementing the requirements as outlined in the site / project Validation Master Plan.
  • Coordination of engineering sub-teams in the assigned suite during execution of Cycle Development & Validation activities.
  • Authoring and reviewing standard operating procedures and technical reports including PQ protocols.
  • Technical review and approval of Commissioning protocols, Qualification protocols and Validation protocols executed by vendors, cross functional groups and/ or validation counterparts.
  • Supporting regulatory submissions as required.
  • Owning Change Management process for Equipment introduction within the assigned suite for qualification / validation up to PQ stage.
  • Effective application of LeanSixSigma and Change Management tools in the Validation group by:
    • Leading by example in achieving results by using industry standard tools and processes.
    • Facilitate problem solving & risk assessment (FMEA) projects/meeting.
    • Make problems visible and strive for continuous improvement.
    • Serving as a key member during internal audits and external inspections/audits.
    • Supporting alignment and knowledge exchange with development organizations, other commercial nodes and external manufacturing partners.
  • Lead and support various organizational initiatives as needed (examples include EHS, workload forecasting, work standardization, etc.)
  • Represent the site in internal collaborations through Manufacturing Division Validation Communities of Practice to include sharing of best practices in validation and investigation activities.
  • Keep up to date with scientific and technical developments, best practices and attend seminars as required.
  • Maintain continuous focus on quality and safety compliance and unflinching focus on the customer.
  • Execution in line with the site Continued Process Validation (CPV) program and supporting cross-site CPV as needed.

 

Minimum Qualifications and Experience:

  • With relevant technical qualification(s) in Applied Pharmaceutical / Biological / Computer / Chemical sciences or applied Technical / Engineering qualification, the successful candidate will also have a proven track record in delivering excellence.
  • An experienced individual with a minimum of 5 years directly related experience in academia, pharmaceutical or biotechnology industry – along with a working knowledge of current regulatory requirements and current Good Manufacturing Practices.
  • A self-starter and results-focussed, the successful candidate will have strong contemporary knowledge, and the ability to work independently and on multidisciplinary teams.
  • The successful candidate will also have demonstrated the ability to deliver what is needed on-time, holding self and team members accountable for commitments, decisions, actions and behaviours.
  • Excellent oral and written communication skills, with the ability to effectively articulate understanding of process science, in order to drive decision making, impact assessments, design of studies, etc., in a multi-disciplinary team environment.
  • The candidate will also show ambition and drive to develop and advance within the role.

 

 

11586 – Instrumentation Engineer - Carlow

Responsibilities:

  • The Engineer will take ownership for the site Instrumentation & Control systems (such as, but not limited to Instrumentation, QBMS/NQBMS, Delta-V, SCADA, APC, DCS, PLCs, Calibration, Energy, etc.)
  • Provide leadership, cross functional support and technical expertise to IUFT, maintenance and manage their operation through design, construction, validation, start-up and commercial manufacturing.
  • Ensure that objectives are effectively achieved, consistent with the company’s requirements to ensure compliance, safety and reliable supply to our customers.
  • The Instrumentation & Control Engineer will collaborate across functions, supporting, coaching and facilitating project sub-teams. Together, this dynamic group will meet the required project schedule milestones, in accordance with the applicable company standards for Quality and EHS compliance.
  • Responsible for delivery of schedule milestones throughout project duration.
  • Collaborate and work cross functionally to develop and deliver on all aspects of the project through URS, FAT, SAT, IC, OC, IQ, OQ, PPQ and commercialization to meet schedule milestones.
  • Driving operational and technical excellence to deliver all components of a stable support utility (I&C) equipment portfolio supporting PPQ, facility start-up and commercial supply, supported by a flexible, collaborative, multi-skilled teamwork environment.
  • Assist with the design and operationalisation of a successful IUFT that delivers right-first-time Instrumentation & Controls equipment to achieve production requirements.
  • Resolve issues and escalate risks in a timely fashion to the relevant on-site stakeholders.
  • Comply with the current company Manufacturing Division, Quality and EHS Management System requirements, as relevant to the project and commercial operations.
  • PLC Programming of Siemens S7 300 / 1200 / 1500, Win CC including Profibus and Profinet communications.
  • Setting up Drives including Mitsubishi, Siemens and Control Techniques.
  • Designing, Setting up and maintaining Instrumentation.
  • Drive effective writing/revising/ rolling out of accurate operational procedures, training materials and maintenance procedures for various IUFT systems; ensure all work is subsequently carried out in line with same.

 

Minimum Qualifications and Experience:

  • Degree qualification or equivalent (Science, Engineering, Technical.)
  • 3 + years of related work experience in a GMP manufacturing environment or equivalent.
  • Expertise of Instrumentation and control devices including PLC control.
  • Expertise in Calibration systems/Programs (Procal.)
  • Experience of Laboratory Analytical equipment an advantage.
  • Experience of Utility systems an advantage.
  • Experience of Energy Management systems an advantage (ISO 50,001.)
  • Lean Six Sigma Methodology experience desired.
  • Evidence of continuous professional development is desirable.
  • Demonstrating energy and enthusiasm, the Instrumentation & Controls Engineer, will be a role model for operational excellence, and will contribute to the organisation’s overall capability to thrive and grow.
  • Experience with GMP cleanroom facility and utilities commissioning, qualification and startup an advantage.
  • Demonstrated site operations project experience, from capital project to continuous support to manufacturing operations.
  • Proven track-record in delivering results in a world-class supply organisation.
  • A strong career history in pharma and familiarity with a highly regulated environment.
  • Innovative thinker, with excellent decision-making and problem-solving skills.
  • Experience of working in a cross functional environment.
  • Knowledge of and experience in applying Six Sigma and Lean methodologies.
  • Positive, flexible action-oriented attitude.
  • SME (subject matter expert) in Instrumentation & Controls Engineer lifecycle (design, through to sustaining operations; including ARM – asset reliability maintenance.)
  • SME in Instrumentation & Control systems (such as, but not limited to Instrumentation, QBMS/NQBMS, Delta-V, SCADA, APC, DCS, PLCs, Calibration, Energy, etc.)
  • Knowledge of regulatory/code requirements to Irish, European and International Codes, Standards and Practices.
  • Report, standards, policy writing skills required.
  • Proficiency in Microsoft Office and job related computer applications required.
  • Lean Six Sigma Methodology experience desired.
  • Lead, promote, participate and supervise the implementation and maintenance of the relevant safety programmes.
  • Delivery of safety, performance and quality goals.
  • Build diverse talent with the capabilities necessary to succeed in commercial vaccine manufacture; inspire, reward and develop to ensure individuals reach their potential; make tough calls when necessary.
  • Set clear performance standards; overcome obstacles; hold ourselves and others accountable for achieving results.
  • Foster a culture of continuous improvement by deploying company Six Sigma tools and support implementation of Model Area within operations from the start.
  • Expected travel – 20%

 

 

11585 – Utilities Engineer - Carlow

Responsibilities:

  • The Engineer will take ownership for the support utilities (such as, but not limited to, chilled water, cooling towers, heating hot water, plant steam, process waste, instrument air, freezers, CTU (controlled temperature units), process and potable water, electrical power, non-GMP HVAC – heating ventilation and air conditioning). Responsible for the support utilities equipment.
  • Provide leadership, cross functional support and technical expertise to IUFT, maintenance and manage their operation through design, construction, validation, start-up and commercial manufacturing. Ensure that objectives are effectively achieved, consistent with the company’s requirements to ensure compliance, safety and reliable supply to our customers.
  • The support utilities engineer will collaborate across functions, supporting, coaching and facilitating project sub-teams. Together, this dynamic group will meet the required project schedule milestones, in accordance with the applicable company standards for Quality and EHS compliance.
  • Responsible for delivery of schedule milestones throughout the project duration.
  • Collaborate and work cross functionally to develop and deliver on all aspects of the project through URS, FAT, SAT, IC, OC, IQ, OQ, PPQ and commercialization to meet schedule milestones
  • Driving operational and technical excellence to deliver all components of a stable support utility equipment portfolio supporting PPQ, facility start-up and commercial supply.
  • Assist with design and operationalisation of a successful support utilities team that delivers right-first-time utilities to achieve production requirements.
  • Resolve issues and escalate risks in a timely fashion to the relevant on-site stakeholders.
  • Comply with the current company Manufacturing Division, Quality and EHS Management System requirements, as relevant to the project and commercial operations.
  • Ensure that the support utilities team receive appropriate resources and programmes to develop technical and other skills, to complete their jobs whilst stimulating personal growth and development in line with role.
  • Develop and maintain training programmes.
  • Drive effective writing/revising/ rolling out of accurate operational procedures, training materials and maintenance procedures for various IPT systems; ensure all work is subsequently carried out in line with same.

 

Minimum Qualifications and Experience:

  • Degree qualification or equivalent (Science, Engineering, Technical.)
  • Experience in manufacturing utilizing support utilities such as chillers, CTUs and boilers.
  • Evidence of continuous professional development is desirable.
  • Demonstrating energy and enthusiasm, the support utilities engineer, will be a role model for operational excellence, and will contribute to the organisation’s overall capability to thrive and grow.
  • Experience with facility commissioning and startup an advantage.
  • Demonstrated site operations project experience, from capital project to continuous support to manufacturing operations.
  • A strong career history in pharma (ideally working with support utilities) and familiarity with a highly regulated environment.
  • Experience of working in a cross functional environment.
  • Knowledge of and experience in applying Six Sigma and Lean methodologies.
  • SME (subject matter expert) in support utility engineering lifecycle (design, through to sustaining operations; including ARM – asset reliability maintenance.)
  • SME in mechanical, electrical, refrigeration, temperature control, fluid and pneumatic utility systems.
  • Knowledge of regulatory/code requirements to Irish, European and International Codes, Standards and Practices.
  • Report, standards, policy writing skills required.
  • Proficiency in Microsoft Office and job related computer applications required.
  • Lean Six Sigma Methodology experience desired.
  • Lead, promote, participate and supervise the implementation and maintenance of the relevant safety programmes.
  • Delivery of safety, performance and quality goals.
  • The passion to expand the future of Carlow.
  • Build diverse talent with the capabilities necessary to succeed in commercial vaccine manufacture; inspire, reward and develop to ensure individuals reach their potential; make tough calls when necessary.
  • Expected travel – 20%

 

 

11571 – Technical Specialist – Materials Review – Cork

Purpose:

The Technical Specialist will deliver on timely implementations of Supplier Change Notifications by conducting detailed technical assessments of the change, while working collaboratively with all internal departments and external partners, to meet the company Manufacturing Division Priorities of: Compliance, Supply, Strategy and Profit Plan.

Responsibilities:

  • Ensure highest Quality, Compliance and Safety standards are adhered to.
  • Lead and manage suppler changes assigned. Ensure that key stakeholders both internal & external are kept informed throughout the change control lifecycle process.
  • Conduct detailed technical assessments of materials and supplier changes from a Safety, Quality, Technical and Supply perspective and proactively manage the implementation of changes through the site change control process.
  • Provide ongoing input and support to the MRB team members, support continuous process improvement initiatives, share their technical knowledge and promote best practices.
  • Participate in problem solving teams as necessary.
  • Support the building and fostering relationships with internal and external stakeholder’s.

 

Minimum Qualifications and Experience:

  • Degree in a Science or Engineering discipline.
  • Lean Six Sigma qualification or experience in application of lean principles is desirable (but not essential).
  • Project Management qualification is desirable (but not essential).
  • Evidence of Continuous Professional Development is desirable (but not essential).
  • Minimum 4-5 years’ experience in a regulated manufacturing environment – ideally has worked in either a technical / validation / process engineering position
  • Demonstrated Technical knowledge in pharmaceutical or Biopharmaceutical operations (e.g. manufacturing, technology, engineering, quality)
  • Understanding of the change control process in a regulated manufacturing environment.
  • Knowledge of material qualification and supplier change notifications.
  • Change management understanding and skills (i.e. Trackwise)
  • Knowledge of Quality Supplier systems (i.e. supplier Transparency system)
  • Project Management skills and the ability to lead a project.
  • Stakeholder management and management of multi decision makers in cross functional teams.
  • Demonstrated capability to deliver results RFT, in an FDA / HPRA Regulated production environment.
  • Demonstrated high level of problem solving and facilitation skills.
  • Working proactively and collaborating across multiple functional teams.
  • Experience dealing with external suppliers/ partners.

 

11556 – Process Equipment Engineer – Dublin

Responsibilities:

  • Responsible for the Manufacturing Equipment within the BDS building, including but not limited to Bioreactors, Depth Filtration, Centrifugation, Chromatography, Ultrafiltration/Diafiltration and Process Support systems.
  • Engineering expert for specific Manufacturing Upstream and Downstream Areas, have an in-depth knowledge of process operations and equipment to support Manufacturing, Quality, Automation, Validation, and EHS for deviation investigation, change controls, and CAPA’s.
  • Technical expert for equipment and accountable for changes to ensure continued compliance of the manufacturing equipment. Generation of requirement for any Equipment/Automation improvements/modifications/projects.
  • Ensuring all the systems are in compliance with all Regulatory requirements including Quality, EHS, Global Engineering, design & construction standards, requirements & procedures, as well as all Local Regulatory requirements.
  • Supporting internal and external audits as the Engineering SME.
  • Responsible for Clean in Place (CIP) and Steam in Place (SIP) changes, support of Validation including periodic assessment.
  • Accountable for redlining, reviewing and approving of Automation Functional Specifications and ensuring implementation of software changes to the PAS.
  • Review and approval of Drawing updates, and support of out of Specification investigations related to Calibration of critical equipment.
  • Perform but not be limited to the following activities: Periodic QRA review of Process equipment, addressing equipment issues identified by IPTs, installation modification of equipment and systems, reducing equipment downtime, support of compliance efforts related to Investigations, CAPA and change management.
  • Be an advocate of the company’s Production System and continuous improvement.

 

Minimum Qualifications and Experience:

  • The successful candidate will have a BEng in Engineering (Chemical or Mechanical preferred) with 6 years plus experience (or equivalent) with manufacturing equipment support in the Biotechnology manufacturing industry, as well as GMP experience.
  • Significant knowledge and expertise of engineering principles related to and expertise with typical biopharmaceutical upstream and downstream processing and support equipment including but not limited to bioreactors, filtration and ultra filtration, CIP, SIP, centrifugation, chromatography, autoclaves, and parts washers.
  • Candidates must be effective in both a team environment and an individual contributor role.
  • The job requires high level of technical knowledge and the candidate should have the ability to proactively troubleshoot.
  • In-depth knowledge of DeltaV, or other process automation software required; ability to use process historian and analyze data to assist troubleshooting.
  • Experience dealing with Regulatory Agencies.

 

 

11496 – QA IT Specialist - Cork

Purpose:

Provide independent oversight and support for the existing and new computerised systems on a major capital project. The QA IT specialist will ensure that the relevant computerised systems are compliant with regulatory expectations and company Computer Systems Validation (CSV), System Development Lifecycle (SDLC), Cyber Security and Data Integrity requirements. Systems in scope will include process control systems, BMS, historian and MES.

Responsibilities:

  • Providing independent quality review and approval of system lifecycle documentation, such as plans, requirements, risk assessments, test protocols and reports for new and modified systems.
  • Providing independent quality review and approval of system changes.
  • Supporting and approving computerised systems investigations and deviations.
  • Ensuring consistent approach to qualification, change and deviation management across systems and projects.
  • Managing and prioritising day-to-day activities through active alignment with the project team, and supporting other areas as needed.
  • Providing timely and pro-active QA IT support and guidance to facilitate project timelines.
  • Where required, engaging with QA IT teams from other sites to standardise and align approach to computerised systems compliance.

 

Minimum Qualifications and Experience:

  • 5 years of experience in QA IT/CSV, CSV and/or a similar role in the pharmaceutical industry.
  • Expert knowledge of relevant regulations and industry standards.
  • Proven ability to meet timelines, prioritise tasks and engage with stakeholders.
  • Excellent communication skills.
  • Project management experience will be an advantage.
  • PLC/SCADA, OSI PI and PAS-X experience will be an advantage.

 

 

9917361 – QA Specialist III - Dublin

Purpose:

The QA Specialist for the Bulk Drug Substance (BDS) facility at the site will be responsible, with management support, for providing oversight of quality activities associated with the manufacturing and disposition of bulk drug substances at the site. He/she is responsible for ensuring that manufacturing, testing, labeling, and storage of Bulk Drug Substances comply with all applicable regulations. This responsibility includes the oversight of the site QMS to ensure that quality and compliance requirements are followed in line with business needs.

The Senior QA Specialist executes the site QA activities in order to protect the safety, quality and efficacy of our products, thereby ensuring the availability of correct, safe product for our Patients, and assuring the security of the company’s business and global markets. This key role must ensure effective interaction with other departments and locations regarding GMP Document review and finished product releases. In particular, this will involve partnering with major stakeholders such as Operations, QC, QPs, Facilities, Engineering and Supply Chain to optimize patient supply.

Responsibilities:

  • Provide quality and cGMP input and oversight for all start-up project activities through commercial readiness for the BDS facility
  • Review and approval technical support documentation. (Examples include cleaning, process, method validation).
  • Review and approval of functional area documentation (SOPs, Work Instructions, technical reports and protocols)
  • Participate in quality risk assessments and provide quality oversight to ensure quality risk assessments are effectively maintained/ controlled.
  • Provide support and expertise for inspection readiness activities, during health authority inspections including interaction with inspectors, responses to inspection observations, to monitor progress of follow up actions.
  • Responsible for review and approval of Master Batch Records in accordance with the company’s internal procedures and GMP principles.
  • Responsible for review and approval of Master electronic Batch Record recipes in accordance with the company’s internal procedures and GMP principles
  • Provide oversight of quality management system activities including Preventive Maintenance, Deviation Management and the Change Control Programs
  • Provide quality oversight of calibration and preventative maintenance criticality assessments as required.
  • Author, review and approve Quality Related Procedures as required
  • Support the Vendor Management Program.
  • Support the Raw Material Qualification Program.
  • Develop and report quality metrics

 

Minimum Qualifications and Experience:

  • Academic degree in natural or applied sciences (Pharmacy, biology, biotechnology, engineering)
  • Minimum 5 years in international pharmaceutical and/or biotech industry with increased level of responsibility
  • Sound awareness and understanding of pharmaceutical business, especially with regards to quality and regulatory requirements
  • Demonstrated success records in auditing and improvement processes
  • Ability to operate efficiently in a complex matrix organization and international environment
  • Strong mature leadership and interpersonal influencing skills
  • Strong verbal and written communication skills with well-structured communication and presentation ability to various audience levels
  • English fluency written and spoken (the Company language)
  • Efficient in SAP, EMDS, MES and Trackwise

 

 

10570312 – QA Specialist III – Dublin

Purpose:

The Senior QA Specialist for the Bulk Drug Substance (BDS) facility will be responsible, with management support, for providing oversight of quality activities associated with the manufacturing and disposition of bulk drug substances. They are responsible for ensuring that manufacturing, testing, labeling, and storage of Bulk Drug Substances comply with all applicable regulations. This responsibility includes the oversight of the site to ensure that quality and compliance requirements are followed in line with business needs.

The Senior QA Specialist executes the site QA activities at the company in order to protect the safety, quality and efficacy of our products, thereby ensuring the availability of correct, safe product for our Patients, and assuring the security of the company’s business and global markets. This key role must ensure effective interaction with other departments and locations regarding GMP Document review and finished product releases. In particular, this will involve partnering with major stakeholders such as Operations, QC, QPs, Facilities, Engineering and Supply Chain to optimize patient supply.

Responsibilities:

  • Provide quality and cGMP input and oversight for all start-up project activities through commercial readiness for the facility
  • Review and approval technical support documentation. (Examples include cleaning, process, method validation)
  • Review and approval of functional area documentation (SOPs, Work Instructions, technical reports and protocols)
  • Participate in quality risk assessments and provide quality oversight to ensure quality risk assessments are effectively maintained/ controlled.
  • Provide support and expertise for inspection readiness activities, during health authority inspections including interaction with inspectors, responses to inspection observations, to monitor progress of follow up actions.
  • Responsible for review and approval of Master Batch Records in accordance with the company’s internal procedures and GMP principles.
  • Responsible for review and approval of Master electronic Batch Record recipes in accordance with the company’s internal procedures and GMP principles
  • Provide oversight of quality management system activities including Preventive Maintenance, Deviation Management and the Change Control Programs
  • Provide quality oversight of calibration and preventative maintenance criticality assessments as required.
  • Author, review and approve Quality Related Procedures as required
  • Support the Vendor Management Program.
  • Support the Raw Material Qualification Program.
  • Develop and report quality metrics

 

Minimum Qualifications and Experience:

  • Academic degree in natural or applied sciences (Pharmacy, biology, biotechnology, engineering)
  • Minimum 5 years in international pharmaceutical and/or biotech industry with increased level of responsibility
  • Sound awareness and understanding of pharmaceutical business, especially with regards to quality and regulatory requirements
  • Demonstrated success records in auditing and improvement processes
  • Ability to operate efficiently in a complex matrix organization and international environment
  • Strong mature leadership and interpersonal influencing skills
  • Strong verbal and written communication skills with well-structured communication and presentation ability to various audience levels
  • English fluency written and spoken (the Company language)
  • Efficient in SAP, EMDS, MES and Trackwise

 

 

10456804 – QA Manager (QP) - Dublin

Purpose:

The Qualified Person is responsible to ensure that licensed Finished Product is certified and released to market by a Qualified Person named on the commercial manufacturing license in accordance with EU directive 2001/83/EC, 2004/94/EC and in accordance with the requirements of Annex 16. To ensure that investigational medicinal product (IMP) is certified and released to sponsor by a Qualified Person named on the IMP Manufacturing License in accordance with EU directive 2001/20/EC and in accordance with the requirements of Annex 16 and Annex 13.

Responsibilities:

  • Principal certification of batches of company products prior to use in clinical trials and prior to release for sale and placing on the market
  • Provide quality and compliance guidance on all critical and major quality matters.
  • Provide support to Regulatory for Regulatory submissions (IMPD, MAA) / QP declarations and License updates.
  • Creates an environment for ‘right first time’ in focusing on principles of lean, visual management and building in efficiencies as necessary from a systematic and compliance perspective.
  • Review and approving of APQRs as required.
  • Provide audit support as required for internal auditing program and supplier audits.
  • Maintain an up-to -date knowledge of pharmaceutical legislation and industry practice.

 

Minimum Qualifications and Experience:

  • Bachelor’s degree required; preference given to candidates with advanced degrees
  • Eight or more years of cGMP experience preferred; consideration will be given to other relevant experience and education.
  • Must have a minimum of 1 years’ experience acting as a Qualified Person
  • Minimum 5 years GMP related experience in biopharmaceutical / pharmaceuticals.
  • Eligible and demonstrated ability to act as Qualified Person within EC/EEA.
  • Detailed experience of Quality Assurance of aseptic medicinal products and in particular biopharmaceuticals.
  • Must have excellent communication skills, including excellent written, interpersonal, collaboration, and negotiation skills, with a team oriented approach.
  • Extensive demonstrated pharmaceutical quality experience.
  • Must have thorough knowledge of biopharmaceutical / pharmaceutical manufacturing, packaging, testing, and distribution processes and associated global regulatory GMP/GDP requirements.
  • Must have demonstrated understanding of the processes and interactions essential for ensuring and maintaining regulatory compliance.
  • Must have strong task management skills with the ability to prioritize, schedule, and control under tight deadlines.

 

 

11445 – QA Technical Specialist - Cork

Purpose:

The Analytical Sciences (AS) group require a Technical Specialist with strong analytical experience to provide multidisciplinary expertise and technical support to the Analytical Sciences team. The successful candidate will be responsible for assisting in the effective and efficient running of analytical projects and will be active members within the wider Technology team to provide Technical support, guidance and expertise to ensure the success of the team. A high level of innovation, enthusiasm and drive will be required to deliver technical excellence for a number of analytical transfers, method development, method qualifications, and small scale process optimisation studies. The Scientific Technical Specialist provides in-line technical support to ensure the continued manufacture and supply of quality pharmaceutical products in meeting the company priorities of: Compliance, Supply, Strategy and Profit Plan. This role is responsible for all aspects of method and equipment validation, assisting in the effective and efficient running of the method, equipment validation and small scale optimisation operations programs. In addition, providing on-going technical support to the site in the area of contamination control. Works with moderate work direction and is skilled and knowledgeable to the position.

Responsibilities:

  • Knowledgeable in protein chemistry and analytical techniques in a Chemistry Separations laboratory (e.g. HPLC, GC, CE, SDS-PAGE and protein biochemistry etc.), Method validations, method transfers and Equipment qualifications in a GMP environment.
  • Perform laboratory experiments required to deliver on project timelines.
  • Participate in continuous improvement initiatives, including method optimisation and troubleshooting.
  • Preparation of documentation associated with the projects in accordance with GDP (good documentation practice) and site procedures.
  • Lead and Participate in cross-functional projects, problem solving teams for troubleshooting, and investigations across site.
  • Prepare, review and approval of technical documents, procedures, CAPAs, change control, deviations, metrics, etc.
  • Adhere to highest quality standards.
  • Build diverse talent with the capabilities necessary to succeed in our markets; inspire, reward and develop to ensure individuals reach their potential; make tough calls when necessary.
  • Preparation of documentation associated with the projects in accordance with GDP (good documentation practice) and site procedures.
  • Prepare, review and approval of technical documents, procedures, CAPAs, change control, deviations, metrics, etc.

 

Minimum Qualifications and Experience:

  • MSc/BSc. qualification (Science.)
  • At least 3 years’ industry experience working with chemistry techniques (e.g. HPLC, GC, CE, SDS-PAGE and protein biochemistry etc.) in a QC/Analytical role group.
  • Knowledgeable in protein chemistry and analytical techniques such as HPLC, GC, CE, SDS-PAGE and protein biochemistry etc., Method validations, method transfers and Equipment qualifications in a GMP environment.
  • High level written and verbal communications with advanced PC skills.
  • Self-motivated and ability to work as part of a team with good project management skills.
  • Demonstrated ability to fully realize improvement initiatives.
  • Demonstrated successes in a team environment, such as project teams, problem solving teams etc.
  • Stakeholder management of multiple decision makers, corporate colleagues, cross functional teams.
  • Desired Qualifications/Experience: Minitab, Empower3, JMP, Trackwise
  • Project management qualification such as, Project Management Professional (PMP) Evidence of Continuous Professional Development.

 

 

2020-323 – QC & Stability Chemist – Waterford City

Purpose:

To support QC and Stability by ensuring all raw materials, packaging, finished products and Stability samples are analysed in accordance with cGxP.

Responsibilities:

  • To test and complete write up of QC raw material, packaging, finished product and stability samples in a timely & efficient manner.
  • To support all other on-going laboratory functions & requirements.
  • To prepare and review stability summary sheets where required.
  • To ensure that all work carried out is in compliance with the required standards conforming to company, cGxP, SOPs, regulatory regulations and guidelines, safety and environmental guidelines.
  • To identify and make recommendations for improvements as part of a team within or outside the department in order to ensure continuous improvement.
  • Check own work and that of others for accuracy.
  • To assist in the preparation for internal / customer/ regulatory inspections.
  • Involved in internal investigations e.g. Out of Specifications, Incidents & Deviation investigations etc.
  • Draft, review or revise documentation within the company documentation management system.
  • Report any Deviations/Out of Specifications to Senior Chemist and complete in a timely manner.
  • Health & Safety;
    • Implement safety requirements as per site documentation including SOPs, Safety Statement and COPs.
    • Report any defects.

 

Minimum Qualifications and Experience:

  • Qualified to a minimum of honours degree level in Analytical Chemistry, Pharmaceutical science or related discipline.
  • At least two years’ experience working in a related technical environment is preferable but not essential.
  • Proficient in the use of HPLC & associated problem solving.
  • Proficient with Dissolution testing.
  • Strong analytical ability.
  • Quality Orientation.
  • Knowledge & proficiency of Microsoft products including, Excel, Word & Powerpoint.
  • Adaptability – maintain effectiveness in varying environments and with different tasks, responsibilities and people.
  • Broad understanding of regulatory requirements for submission of dossiers in EU, USA, Japan and other jurisdictions.
  • Analysis – secure relevant information and identify key issues and relationships from a base of information; relate and compare data from different sources, identifying cause-effect relationships.
  • Working effectively with team or those outside the formal line of authority to accomplish organisational goals; taking actions that respect the needs and contributions of others, subordinating own objectives to the objectives of the organisation.
  • Making efforts to listen and understand the customer (both internal and external); anticipating and providing solutions to customers needs; giving high priority to customer satisfaction.
  • Safety Awareness.

 

 

10203763 – QC Compliance Optimisation Specialist - Athlone

Purpose:

The company’s Athlone Quality Control is a growing department with responsibility for in-process testing and environmental monitoring. This position is responsible for actively identifying opportunities for process and compliance improvement and translating these into practice. In this role, you should have excellent relationship building and problem-solving skills. A high attention to detail and excellent verbal and written communications skills are vital to success in the role.

Responsibilities:

  • Support implementation of effective shift handover/QC internal communication.
  • Identify and implement improvements to Lab Processes, Layout/flow and 6S type activities.
  • Training – design of induction training to lab, up to area SME level – define the training requirements and implement simplified training program.
  • Planning, scheduling and facilitating continuous improvement workshops and translation of the output to procedural/process updates.
  • Documentation flow and paperwork practices – Improving Right First Time and reducing GDP errors within QC and implementing processes to track and trend performance against targets.
  • Develop simplified and effective scheduling for routine/non routine activities to maximise available resources.
  • Implementation of real time review and real time trending of all QC data.
  • Support Implementation of in-house microbial identification using the Vitek including the design of process, documentation and training program.
  • Maintain regular and proactive communication with all stakeholders.

 

Minimum Qualifications and Experience:

  • Degree in science/pharmaceutical related subject.
  • At least 10 years’ working in a GMP Quality Control Laboratory.
  • Knowledge and understanding of GMP/GDP standards.
  • Strong problem solving and leadership experience.
  • Experience in workshop facilitation.
  • Experienced in leading and executing continuous improvement initiatives.
  • Experience of SOP authoring and document management processes.
  • Highly Computer literate, with MS Office (Word, Excel.)
  • Experience of provision training to others.
  • Good working knowledge of QC Microbiology and Chemistry instrumentation and methods.
  • An ability to work independently, as well as a member of a team in a dynamic, fast-paced environment.
  • Excellent communication & presentation skills are essential.
  • Excellent time management organizational skills along with a proven ability to multi-task.

 

 

11269 – C&Q Project Manager - Carlow

Responsibilities:

  • Reporting to GES C&Q Lead EMEA as part of a multi-discipline team responsible for Commissioning & Qualification (C&Q) activities on a multi-product facility.
  • Project Manage the day to day C&Q activities of the C&Q team.
  • Liaise with Project Controls function.
  • The candidate will be a convincing communicator with strong interpersonal skills
  • This candidate will be required to work closely with a cross-functional team and coordinate activities between Construction, Process, Technical Operations, IPT and QA.
  • Report to GES C&Q EMEA Lead / Project Manager on the given project.
  • Support all suite teams during a commissioning and qualification program.
  • Assist the C&Q Technical Lead in the planning and tracking of activities.
  • Actively support Last Planner System activities.
  • Liaise with the various stakeholders on the C&Q team and the overall project to ensure clear communication between all parties.
  • Participation in C&Q activities, as required.
  • Review and Input into deliverables such as technical requirement specifications and vendor turnover documentation.
  • Participate in C&Q deliverables (System Impact Assessment, Critical Component Impact Assessments, System Boundary Drawings, Requirement Traceability Matrix.)
  • Manage generation and execution of C&Q documentation (FAT, SAT, IOC, DQ, IQ, OQ, IOQ) for the project based on available approved client templates & design documentation.
  • Monitor and report on approval of C&Q documentation.
  • Monitor and report review of CCRs and TOPs.
  • Participate in C&Q change controls (FDCNs and PCNs) and drive their closure in a timely manner. Ensure non-conformances & deviations are minimised and closed out in a timely fashion.
  • Support system P&ID walkdown with construction prior to handover. Categorisation of punchlist items & tracking to completion.
  • Support review on all Isometrics, Weld logs, Weld Qualifications, 3rd Party Inspections, Material of Construction and Redlining exercise.
  • Facilitate/expedite Mechanical Completion in conjunction with the Construction team. (Liaise with construction contractors towards successful completion of Construction Turn Over Documentation.)
  • Pre-start up safety checks, LOTO & ensuring timely loop checking and calibrations.
  • Coordinate and supervise third party vendors during SAT execution. Review and approve SAT protocols.
  • Attend daily communication meetings with suite teams, as required.
  • Assist in investigations of process equipment, utility systems, and control system anomalies, as well as safety incidents.
  • Maintain a clean and safe working environment by enforcing procedures, policies, and regulations.
  • Implement company GES C&Q strategies as set out by the GES C&Q Lead EMEA.
  • Ensure that system delivery progresses in accordance with the approved project schedule.
  • Notify C&Q Technical Lead, in a timely manner, of all relevant issues which may impact on system progress.
  • Ability to work in design and construction project environment within Ireland.
  • Coordinate with design and/or project teams to resolve any identified technical issues.
  • Organise / attend all coordination meetings necessary to progress the job.
  • Possess good communication skills.
  • Ensure that all works carried out in C&Q scope or responsibility by construction, commissioning and contract team members are performed in accordance with site safe working practices.
  • Ensure the cohesive operation of cross-functional team and coordinate work for effective and efficient completion.

 

Minimum Qualifications and Experience:

  • Bachelor of Engineering or Science Degree in Engineering or Technology related discipline.
  • Minimum of 5 years’ experience in commissioning and/or validation of USP/DSP/Facilities/Utilities systems within Pharmaceutical industry.
  • Technical knowledge of black utilities and clean utilities systems and equipment, biotechnology processes and a working knowledge of FDA and EU regulations is preferred.
  • Knowledgeable with latest industry standards and guidelines on C&Q, including ISPE/ASTM.
  • Strong interpersonal and communication skills (verbal/written.)
  • Experience in C&Q as a C&Q Lead/Project Manager on a major capital project.
  • Working knowledge of process control systems and automation. DeltaV, syringe & vial line experience beneficial.
  • Knowledge of C&Q documentation required for cGMP process equipment.
  • Fluent in English, written and verbal.
  • Ability to understand project plans and schedules.
  • Working knowledge of word processing, spreadsheets, database management software, CAD software, and PCs.
  • Knowledge of regulations and standards affecting devices, biologics and pharma products.

 

 

9751 – Project Manager Non-IT - Tipperary

Purpose:

Reporting to the Global Engineering Solutions Project Manager. This will be a key role in the GES organization which is currently executing significant Sterile, Pharmaceutical and Chem API projects. The Project Engineer will be a key member of the project management team on a 100MM capital project. The successful candidate will be able to demonstrate a proven track record to lead project delivery efforts and to influence others, be a convincing communicator with strong interpersonal skills and strategic and tactical thinking abilities. Have knowledge of Cleanroom/HVAC/E&I, equipment and utilities systems.

Responsibilities:

  • Assist in the development of project plans and successfully execute them according to established schedule, cost and performance standards.
  • Work closely with EPCM to effectively & efficiently progress the equipment design (dispensing & blending, roller compactor, compression, coating & cleaning.)
  • Manage design, construction, commissioning and qualification, schedule and cost in collaboration with other project team members, company personnel, outside contractors and suppliers.
  • Track and report progress as required against project deliverables.
  • Ensure there is a strong safety culture and performance in the execution of capital projects.
  • Monitor progress of project milestones with all team members and provide status reports. that all project stakeholders are informed and consulted on key project activities, progress and decisions.
  • Develop and maintain appropriate electronic and paper documentation & filing systems to ensure that all project documents are filed during project execution and safely archived following project completion.
  • Ensures that good Engineering practices are utilised and aligned with customer’s needs from requirements gathering, through design and execution.
  • Manage project changes and ensure all are captured, documented and assessed.
  • Manage the execution of Commissioning & Qualification documentation.
  • Manage a change control procedure to the assigned scope.
  • Participate in EPCMv led HAZOP and design reviews as lead GES Representative, ensuring company stakeholder inputs are coordinated and appropriate.

 

Minimum Qualifications and Experience:

  • Must have as a minimum a 3rd level Degree in Engineering, preferably Chemical or Mechanical
  • A minimum of 8 years of relevant experience in project management of capital projects in a high tech industry, preferably in Oral Solid Dosage.
  • Preferable to have a qualification in project management – PMP or equivalent.
  • Proven level of experience in delivering significant capital projects within the pharmaceutical sector.
  • Hands on attitude.
  • Ability to sequence critical activities in planning work for.
  • Ability to coordinate activities to deliver projects to an aggressive schedule.
  • Knowledge of clean room installation an Advantage.
  • Understands the typical project life cycle from concept through to qualification and has proven experience in this area.
  • Familiar with engineering project management tools, financial management skills including an ability to work within budgets, and engineering technical skills.
  • Proven knowledge, appreciation and experience of working in strongly regulated GMP environment.
  • Strong interpersonal skills and an understanding of the customer/client relationship involved in projects.
  • Excellent communication /presentation skills.
  • Superior organizational and planning skills.
  • Demonstrated performance and managing multi-functional teams.
  • Demonstrated experience in leading projects from Design to Qualification.

 

 

11153 – QC Instrumentation Specialist - Dublin

Purpose:

The role of the Instrument Specialist is to ensure the day to day running of all laboratory instruments, minimizing any downtime in the laboratory due to instrumentation issues and ensuring all equipment is installed and maintained in a validated state. The role covers Drug Substance and Drug Product instrumentation in clinical and commercial areas for ADC. The Instrumentation Specialist also has responsibilities for management of selected Analytical Instrumentation in the PDC department.

Responsibilities:

  • The Instrumentation Specialist has overall responsibility for maintaining Laboratory Instrumentation in ADC/PDC. The Instrumentation Specialist will lead troubleshooting activities and use external support as required to meet customer targets.
  • The Instrumentation Specialist is responsible for ensuring all Instrumentation activities comply with cGMP, including acting as auditee for this area. The Instrumentation Specialist assures compliance with all safety and environmental requirements. Compliance with other regulated areas such as trade compliance, human resources and spending are also responsibilities of the role for this scope of work.
  • Installs all instrumentation in accordance with company laboratory validation policies, procedures and guidelines. Reviews and approves validation activities for instrumentation.
  • Provides a preventative maintenance service to ensure functionality and a calibration service to maintain the instruments according to their working specifications. Leads shut-down PM/PV as required and ensures all contract/support personnel on site comply with site safety and GMP requirements.
  • Ensures that all instruments are maintained in a validated state through a PM/PV schedule and ensuring that this schedule is adhered to by the Instrument group and contract vendors.
  • Responsible for troubleshooting issues with all instrumentation, ensuring that incident reports are raised, investigated and closed out as required and for coordinating with vendor service engineers to come on site.
  • Ordering and installing new laboratory equipment, ensuring associated documentation is in accordance with company SDLC (System Development Life Cycle.)
  • Assumes the role of auditee where required for instrumentation and ensures timely closure of any audit observations.
  • Supports the vendor contract development and renewal business process.
  • The incumbent operates as part of self-directed team in carrying out day to day function and assigning priorities.
  • On assignment, the incumbent participates in departmental initiatives on improved compliance and quality systems.

 

 

Minimum Qualifications and Experience:

  • Supports the vendor contract development and renewal business process.
  • 5+ years’ experience.
  • Technical;
    • The Quality System.
    • Plant procedures and policies.
    • Company procedures, policies and guidelines.
    • Plant documentation.
    • Laboratory testing and documentation.
    • Validation principles and guidelines.
    • Computer skills.
    • System Development Life Cycle.
  • Communication skills both written and oral.
  • Team and interpersonal skills.
  • Technical report writing.
  • Time Management.
  • Meetings Management.
  • Analytical Problem-solving skills.
  • Planning and Scheduling.
  • Continuous improvement skills.

 

 

10016773 - Supply Chain Distribution Specialist - Dublin

Purpose:

Responsible for managing and executing end-to-end Logistics processes for the shipment of products from our Manufacturing sites (internal and external) and distribution centres to the final delivery location. In this role, you should have strong logistics experience, problem-solving skills, with a high attention to detail and an excellent communicator both verbal and written with a focus on customer centricity.

Responsibilities:

  • Fully compliant with internal SOP’s, standards and associated training.
  • Coordination and execution of Product shipments across our Global Network (Primary & Secondary nodes.)
  • Manage operational logistics to ensure on-time delivery with no interruption to supply across our Global Network.
  • Support the strategic objectives of the organization focusing on optimizing the logistics network.
  • Manage aspects of the daily compliance requirement.
  • Creation of GMP and non-GMP documentation including procedures, specifications and shipping documentation across Global Logistics.
  • Responsible for CAPA’s, Change Controls & Deviations program and initiate Corrective Action plans in the company Quality Management System.
  • Coordinate introduction of new shipping lanes for new and existing products from commercial launch and clinical to commercial activities with validation SME’s.
  • Maintain regular and proactive communication with all internal and external stakeholders to ensure efficient execution of schedules.

 

 

Minimum Qualifications and Experience:

  • Degree in Business Management, Supply Chain/Logistics, or related field experience preferable.
  • At least 5 years’ working in Pharmaceutical Supply Chain Logistics or Operations role within an international environment is essential.
  • Knowledge and understanding of GMP/GDP standards.
  • SAP Knowledge of SD and MM Environment.
  • Computer literate, with MS Office (Word, Excel, Outlook.)
  • Fluency in English both written and oral is essential; fluency in other languages is desirable.

 

 

11027 - Process Engineer - Cork

Purpose:

The IPT/CoE Process Engineer will provide operational process support and expertise to the IPT/CoE to manufacture quality pharmaceutical products in accordance to meeting the company Priorities of: Compliance, Supply, Strategy and Profit Plan. The team working style is one of collaboration, coaching and facilitating to provide engineering solutions to the IPT/CoE team to support a High Performance Organisation.

Responsibilities:

  • Accountable for supporting the smooth running of the IPT value stream.
  • Responsible for actively participating in the Tier process to manage Engineering projects and proactively resolve issues before they impact the business priorities.
  • Be an active member within the cross functional IPT/CoE Team providing support, guidance and strive for Engineering excellence to ensure the success of the IPT/CoE.
  • Model the company Leadership behaviors and understand the MPS principles to drive a culture of continuous improvement building a High Performance Organisation.
  • Participate and comply with the company Quality Management System (QMS) requirements, including ownership, as relevant to you.
  • Provide ongoing coaching and support to cross functional team members, to share Engineering best practices.
  • Ensure supply of high-quality product through ensuring equipment availability, maximise performance through OEE and continuous process improvement initiatives.
  • Sound manufacturing/Engineering stewardship, equipment resource planning, maintenance scheduling and control. For example, shutdown activities, vendor management, change control.
  • Ensure highest Quality & Compliance standards.
  • Provide Engineering expertise within a wide range of projects within the IPT/CoE, such as the introduction of new equipment, improvement to the filling process etc.

 

Minimum Qualifications and Experience:

  • Appropriate 3rd level or engineering trade qualification.
  • At least three years’ experience in the Pharmaceutical industry or a similar operating environment with experience in an Engineering/Process role in a manufacturing environment.
  • Demonstrated knowledge in more than one pharmaceutical and/or chemical manufacturing operation (e.g. Engineering, Manufacturing, Process etc.)
  • Knowledge of and experience in applying Lean Six Sigma and Lean methodologies and Engineering excellence through OEE, predictive maintenance planning.
  • Demonstrated leadership skills with a continuous improvement focus.
  • Project Management Experience leading projects.
  • Process and technology background: the successful candidate will understand how to drive optimization and OEE.
  • Demonstrated ability in holding project team members responsible for results and being decisive about non-performers.
  • Demonstrated ability to realize improvement initiatives.
  • Demonstrated successes in a team environment, such as project teams, Six Sigma team, PITs etc.
  • Demonstrated high level of problem solving and facilitation skills.
  • Advanced PC skills such as Excel, Word, PowerPoint.
  • Experience with Management Systems such as PM, EHS, PRINCE, Microsoft PM etc.
  • Stakeholder management of multi decision makers, colleagues, peers and cross functional teams.
  • Desirable: evidence of Continuous Professional Development.
  • Desirable: Six Sigma Yellow Belt.
  • Desirable: Project management qualification such as Project Management Professional etc.

 

 

10784 - Talent Acquisition Specialist – Carlow

Purpose:

Talent Acquisition Advisor (TAA). TAA will partner with the business to understand priority needs and will support the hiring of niche business roles specially for our Carlow site. This role will be the point of contact for all headcount reporting, and associated metrics for this area of the business from a TA perspective. The TAA will report to our Ireland Talent Acquisition Lead.

Responsibilities:

  • Supporting sourcing, advertising, mapping for niche roles.
  • Work along- side our GTA RPO recruiters and together will deliver end to end recruitment solutions for the business.
  • Understand the local market and talent supply and trends and be able to leverage external data to influence talent decisions for the business.
  • Support our early talent strategy with the assistance of our early talent specialist for Ireland. This will include but not limited to;
    • Overview of our All Ireland Intern hiring program and associated events with same.
    • Graduate hiring in conjunction with the business and other associated activities regarding Early Talent for Ireland.
  • Preparing and delivering presentations to the business.
  • Supporting all Ireland branding campaigns.
  • Representing the business at key events and fairs if and when is required.

 

Minimum Qualifications and Experience:

  • A Bachelor’s degree or CIPD qualification in a relevant discipline is required.
  • The TAA will have at least 5 years’ experience working in a large matrixed environment – manufacturing, commercial, research and agency/search organization – ideally within the pharmaceutical industry.
  • An experienced TAA with a deep understanding of direct sourcing methodologies, end to end recruitment process knowledge and competency-based interviewing skills and assessment tools is a must-have.
  • Work effectively within HR partnering with COE’s and HR Ops to deliver a holistic talent acquisition service to the business and the candidate.
  • Influential and consultative to foster strong relationship with our clients.
  • An appetite for new technology and be willing to experiment with digital and social solutions that will appeal to talent segments.
  • Thorough understanding of systems and data bases.
  • Be able to produce analytics to support robust business proposals.

 

 

9966920 – LIMS Specialist - Dublin

Purpose:

The QC gLIMS Administrator will be responsible for coordinating, facilitating, and undertaking activities pertaining to Thermo Fisher Sample Manager LIMS system (gLIMS.) The QC gLIMS Administrator will build, develop and maintain LIMS templates and be involved in troubleshooting as required. This role will support The Quality Control team.

Responsibilities:

  • Building, testing, verifying, transferring, reviewing and activation of all data required for Master Data Load in gLIMS.
  • Identify area end user requirements and enhancements to assist with Master Data Load in gLIMS.
  • Ensure the system master data is updated in a timely manner as required by the area.
  • Assist in validation (IQ, OQ, PQ) as required.
  • Author/review of validation protocols and reports to ensure compliance with current regulatory expectations.
  • Investigation of deviations and raising of change controls as required.

 

Minimum Qualifications and Experience:

  • Minimum of degree qualification in relevant science and/or IT discipline
  • 3 years in a QA/QC/Validation/IT function with strong knowledge of CSV/GAMP, 21 CFR Part 11, Project Life Cycle and cGMP Regulations governing GxP data Direct experience maintaining master data in a cGMP environment is required.
  • Good working knowledge of laboratory testing processes and automation using various instrument software packages.

 

 

2020-324 - QC & Stability Team Lead - Waterford City

Purpose:

Prioritising and coordinating the execution of QC and Stability activities in line with department and company requirements.

Responsibilities:

  • Assist the Quality Control Manager in achieving company goals.
  • Day to day scheduling of laboratory activities.
  • Management of the Raw Material testing requirements, & results reporting.
  • Using the existing laboratory tools to generate and maintain performance related metrics.
  • Coaching / Mentoring – support members of team with problem solving and skill development to aid learning and early problem resolution.
  • Recruitment – assist with recruitment of team members in line with resource requirements and to job spec.
  • Timely close out of deviations and/or investigations.
  • Assist with the timely completion of data reviewing as required.
  • To identify training requirements and training of Chemists and organize training as required.
  • To participate in all relevant training to ensure personal training plan is up to date.
  • To calibrate and check calibrations of laboratory instrumentation as required.
  • Take responsibility for issues as they arise and elevating them where necessary.
  • Timely and complete handover of documentation and work in progress.
  • Reporting on results via correct documentation in real time.
  • To draft procedures, protocols, reports and company documentation as required.
  • To ensure that all work carried out is in compliance with the required standards conforming to company, cGxP, SOPs, regulatory regulations and guidelines, safety and environmental guidelines.
  • Adhere to all good housekeeping practices.
  • Facilitate continuous improvement within the QC team.
  • Representing the Quality Control department at internal meetings and communications with customers.
  • Plan all external laboratory testing, ensuring all testing is completed on time in full.
  • Health & Safety;
    • Ensure requirements of company’s Safety Statement are implemented.
    • Continuously promote a positive safety culture by leading by example.
    • Implement safety requirements as per site documentation including SOP’s, Safety Statement and COP’s.
    • Report any defects.
    • If unsure about safety requirements – ask.
  • Recruit, train, manage and develop team.
  • To perform additional tasks as agreed to support effective running of the business.

 

Minimum Qualifications and Experience:

  • Relevant third level qualification.
  • At least 5 years previous relevant experience.
  • Analytical techniques.
  • Operation of laboratory instrumentation.
  • Computer Skills to include MS office, ECDL certification an advantage.
  • Proven time management skills.
  • People management skills.
  • Planning & organizing.
  • Multi-tasking.
  • Project management, knowledge of MS project.
  • Technical writing skills.

 

 

2020-323 - QC & Stability Chemist - Waterford City

Purpose:

To support QC and Stability by ensuring all raw materials, packaging, finished products and Stability samples are analysed in accordance with cGxP.

Responsibilities:

  • To test and complete write up of QC raw material, packaging, finished product and stability samples in a timely & efficient manner.
  • To support all other on-going laboratory functions & requirements.
  • To prepare and review stability summary sheets where required.
  • To ensure that all work carried out is in compliance with the required standards conforming to company, cGxP, SOPs, regulatory regulations and guidelines, safety and environmental guidelines.
  • To identify and make recommendations for improvements as part of a team within or outside the department in order to ensure continuous improvement.
  • Check own work and that of others for accuracy.
  • To assist in the preparation for internal / customer/ regulatory inspections.
  • Involved in internal investigations e.g. Out of Specifications, Incidents & Deviation investigations etc.
  • Draft, review or revise documentation within company documentation management system.
  • Report any Deviations/Out of Specifications to Senior Chemist and complete in a timely manner.
  • Health & Safety;
    • Implement safety requirements as per site documentation including SOPs, Safety Statement and COPs.
    • Report any defects.

 

Minimum Qualifications and Experience:

  • Qualified to a minimum of honours degree level in Analytical Chemistry, Pharmaceutical science or related discipline.
  • At least two years’ experience working in a related technical environment is preferable but not essential.
  • Proficient in the use of HPLC & associated problem solving.
  • Proficient with Dissolution testing.
  • Strong analytical ability.
  • Quality Orientation.
  • Knowledge & proficiency of Microsoft products including, Excel, Word & Powerpoint.
  • Adaptability – maintain effectiveness in varying environments and with different tasks, responsibilities and people.
  • Broad understanding of regulatory requirements for submission of dossiers in EU, USA, Japan and other jurisdictions.
  • Analysis – secure relevant information and identify key issues and relationships from a base of information; relate and compare data from different sources, identifying cause-effect relationships.
  • Working effectively with team or those outside the formal line of authority to accomplish organisational goals; taking actions that respect the needs and contributions of others, subordinating own objectives to the objectives of the organisation.
  • Making efforts to listen and understand the customer (both internal and external); anticipating and providing solutions to customer’s needs; giving high priority to customer satisfaction.
  • Safety Awareness.

 

 

2020-322 - QA Team Lead - Waterford City

Purpose:

Reporting directly to the Quality Assurance Manager, as a critical leader, you will play an integral role within a quality team for a sterile filling facility, transforming the support provided to these functions.

Responsibilities:

  • Provide quality expertise & support to the QA team and site.
  • Implement and maintain compliant quality assurance systems on-site.
  • Leads team of Quality Assurance specialists to excellent performance through a structured quality system delivering compliance, customer service and a positive team-based work environment.
  • Oversees the day to day management of QA systems, directing the workload of the QA Specialists.
  • Provide clear open communication with the QA team and site.
  • Effective interaction with other departments or matters related to quality.
  • Ensure compliance to the Quality Management System is maintained and its effectiveness monitored.
  • Delivery of assigned projects on plan.
  • Work 12/7 shift pattern (4 days on, 4 days off.)

 

 

Minimum Qualifications and Experience:

  • Previous experience in sterile manufacturing and/or operational quality support.
  • 10 years’ experience working in a Healthcare manufacturing environment.
  • Provide ability to provide quality expertise & support to the QA team and site.
  • Proven ability to lead projects across multiple platforms.
  • Experience of managing teams would be a distinct advantage.
  • Effective technical knowledge of sterile manufacturing processes.
  • Management experience.
  • Strong manufacturing background in Quality.
  • Sterile experience highly desirable.
  • Operational experience of quality systems in a dynamic manufacturing environment
  • Detailed knowledge of quality systems.
  • Effective technical knowledge of sterile manufacturing processes.
  • Knowledge of requirements for cGMP, US and EU regulatory requirements.
  • Full understanding of relevant quality and compliance regulations.
  • Able to manage projects to plan/budget.
  • Effective facilitator.
  • Good communication skills at organisation, team and individual levels.
  • Understands KPI’s for the team and site.
  • QP eligible.

 

 

2020-320 - Junior Process Engineer - Clonmel

Purpose:

Reporting directly to the Operations Team Management, the role will support and actively participate in the delivery of Production and Engineering objectives, with particular focus on process and quality improvements.

Responsibilities:

  • Support the development and implementation of projects while maintaining safety, environmental and company standards and procedures.
  • Manage and report on specific projects and investigations as part of the overall Operations Excellence project.
  • Analytics of Key process variables and reporting on same.
  • Develop & promote solution-based protocols arising from manufacturing issues.
  • Support the commissioning stage of projects and process upgrades.
  • Further actions in planning of 3-year safety plan and Operations Excellence plan.

 

 

Minimum Qualifications and Experience:

  • HETAC Level 8 Degree in engineering discipline, or similar with relevant experience.
  • Experience with the use of lean manufacturing tools.
  • Excellent interpersonal skills in directing and influencing teams and building strong collaborations.
  • Possess an understanding of a manufacturing environment and process led activities.
  • High energy and commitment to Best Practice and Continuous Improvement.
  • Self-motivated and enthusiastic.

 

 

2020-319 - Project Engineer - Clonmel

Purpose:

This person will be part of engineering team tasked with delivering large capital program. They will be responsible for initial stakeholder consultation, project scoping, initial engineering, procurement, day to day project management and safe handover of project upon completion. The person should be able to communicate project information effectively with all stakeholders.

Responsibilities:

  • Ensure projects are compliant with all relevant health, safety, environmental, quality standards and procurement policy.
  • Lead key improvement projects.
  • Provide innovative solutions, pre-engineering activities and project cost estimates for Strategic and Capital projects.
  • Develop tender documents for Projects.
  • Direct and manage all stages of each project from planning to completion throughout the project lifecycle.
  • Draft and submit budget proposals, deliver progress reports and manage project resource allocations.
  • Provide leadership and direction to project teams and technical assistance to operations & maintenance teams as required.
  • Manage day-to-day operational aspects of a project. Ensure project documents are complete, current, and stored appropriately.
  • Ensure proper handover to operations on completion including key aspects of safety, training & communication.
  • Determine compliance position in aspects of ATEX, Dust, Pressure vessels, Fire protection and Asset condition outlining path to modernization.

 

Minimum Qualifications and Experience:

  • BEng Degree in Electrical/Mechanical Engineering or alternative Engineering discipline.
  • 3+ years relevant experience in a project management /engineering capacity in large manufacturing/industrial setting. Electrical experience advantageous.
  • Competent working knowledge of project management systems and software.
  • PLC/NETWORKING/HT experience advantageous.
  • CAD/Drafting/Modelling advantageous.
  • Ability to effectively prioritize and execute tasks within time constraints.
  • Basic financial skills.
  • High level of motivation and commitment to best practice and continuous improvement.

 

 

2020-318 - Technical and Process Specialist - Clonmel

Purpose:

The Technical and Process Specialist will provide scientific and technical support of engineered wood panel manufacture through all stages of the product life cycle, from technology transfer, process validation, manufacturing support, continuous improvement programs.

Responsibilities:

  • Implement strategic process and product development objectives and plans through innovation and PMF models.
  • Support and actively contribute to technical & development initiatives while complying with all relevant regulatory, safety, technical and quality standards.
  • Contribute to operational excellence for process and quality improvement.
  • Contribute to a quality and customer focused innovative culture within the company.
  • Be able to plan and execute measurable commercial, and technology transfer projects.
  • In conjunction with the operating area develops operating procedures, SOPs and start up documentation.
  • Develop strong working relationships both internally across department and externally with industrial partners.

 

Minimum Qualifications and Experience:

  • Relevant HETAC level 8 in Science with a bias towards Chemistry or Chemical Engineering.
  • Minimum two years’ experience in industry.
  • Good knowledge on GMP, Lean Principles, analytical methods.
  • Excellent communication, research and presentation skills required.
  • Attention to detail in compliance with product certification and standards.
  • Strong teamwork with the ability to relate to people across a wide range of operational levels.
  • Creative thinker and be able to work under own initiative.

 

 

9741959 – Senior QA Specialist – Dublin

Purpose:

The Senior QA Specialist for the Bulk Drug Substance (BDS) facility will be responsible, with management support, for providing oversight of quality activities associated with the manufacturing and disposition of bulk drug substances. They are responsible for ensuring that manufacturing, testing, labeling, and storage of Bulk Drug Substances comply with all applicable regulations. This responsibility includes the oversight of the site QMS to ensure that quality and compliance requirements are followed in line with business needs. The Senior QA Specialist executes the site QA activities at the company in order to protect the safety, quality and efficacy of our products, thereby ensuring the availability of correct, safe product for our Patients, and assuring the security of the company’s business and global markets. This key role must ensure effective interaction with other departments and locations regarding GMP Document review and finished product releases. In particular, this will involve partnering with major stakeholders such as Operations, QC, QPs, Facilities, Engineering and Supply Chain to optimize patient supply.

Responsibilities:

  • Provide quality and cGMP input and oversight for all NPI project activities through commercial readiness for the facility.
  • Review and approval technical support documentation. (Examples include cleaning, process, method validation.)
  • Review and approval of functional area documentation (SOPs, Work Instructions, technical reports and protocols.)
  • Participate in quality risk assessments and provide quality oversight to ensure quality risk assessments are effectively maintained/ controlled.
  • Provide support and expertise for inspection readiness activities, during health authority inspections including interaction with inspectors, responses to inspection observations, to monitor progress of follow up actions.
  • Responsible for review and approval of Master Batch Records in accordance with the company’s internal procedures and GMP principles.
  • Responsible for review and approval of Master electronic Batch Record recipes in accordance with the company’s internal procedures and GMP principles.
  • Provide oversight of quality management system activities including Preventive Maintenance, Deviation Management and the Change Control Programs.
  • Provide quality oversight of calibration and preventative maintenance criticality assessments as required.
  • Author, review and approve Quality Related Procedures as required.
  • Support the Vendor Management Program.
  • Support the Raw Material Qualification Program.
  • Develop and report quality metrics.

 

 

Minimum Qualifications and Experience:

  • Academic degree in natural or applied sciences (Pharmacy, biology, biotechnology, engineering.)
  • Minimum 5 years in international pharmaceutical and/or biotech industry with increased level of responsibility.
  • Sound awareness and understanding of pharmaceutical business, especially with regards to quality and regulatory requirements.
  • Demonstrated success records in auditing and improvement processes.
  • Ability to operate efficiently in a complex matrix organization and international environment.
  • Strong mature leadership and interpersonal influencing skills.
  • Strong verbal and written communication skills with well-structured communication and presentation ability to various audience levels.
  • English fluency written and spoken (the Company language.)
  • Efficient in SAP, EMDS, MES and Trackwise.

 

 

10573 - Process Engineer - Tipperary

Purpose:

Our Formulation R&D facility is the first purpose-built facility supporting oral solid dosage commercialisation within the company network. Within this facility new drug product processes are developed, scaled up and optimised using cutting edge manufacturing technology to provide product for clinical trials and commercial supply. This position is for an Associate Specialist MES Engineer in the technical area of the formulation facility.

Responsibilities:

  • Working in conjunction with Process Engineers, Perform MBR authoring and MBR updates in Werum Paz X for new and existing OSD processes.
  • Providing strong MES/Werum Pax-X support to production teams including support to daily operations, problem solving/issue resolution and driving continuous improvement.
  • Develop/create MBR design elements (building blocks) and workflows in Werum PAS-X.
  • Participation in continuous improvement programs to implement improvements in the quality, safety, environmental and production systems.
  • Documentation of all activities in line with cGMP requirements.

 

Minimum Qualifications and Experience:

  • Bachelors or postgraduate degree in Engineering or a Science related discipline.
  • Ideal candidate will have minimum of 2 years relevant experience in Oral Solid Dosage.
  • 2+ years of hands-on experience on MES Product, MBR design & Werum PAS-X product.
  • Strong knowledge of cGMP and regulatory requirements relating to the pharmaceutical industry is required.
  • Ability to work independently as well as in a team environment.
  • Strong MES/IT applications aptitude.
  • Have Strong communication skills and technical writing skills.
  • Have strong problem-solving skills.
  • Excellent Working knowledge of MES, in particular Werum PAS-X.
  • Working knowledge of SAP would be beneficial.

 

 

10555 - Automation Engineer - Tipperary

Responsibilities:

  • Development of Process Control Applications on DCS, PLC and BMS platforms.
  • Identify, evaluate & implement opportunities for continuous improvement.
  • Provide day to day support to Operating Areas for Automation components of the process.
  • Proactively resolve technical issues before they impact the business priorities.
  • Support the smooth running of the site value stream and supply by delivering a world-class Automation service.
  • Ensure adherence with standards, following business processes in the execution and support of Automation systems.
  • Comply with Global Policies, Procedures and Guidelines, regulatory requirements and execute current Good manufacturing Practices (cGMP) in the performance of day to day activities and all applicable job functions.
  • Work collaboratively to drive a safe and compliant culture Core Competencies Technical.
  • Computer System Development Lifecycle.
  • DCS Systems.
  • PLC – Siemens TIA Portal, Siemens S7, Allen Bradley.
  • SCADA – Siemens WinCC, Wonderware, Allen Bradley Factorytalk.
  • Data Historians.
  • BMS Systems – Siemens Desigo.
  • Control System/Shopfloor Integration.
  • System Virtualisation.

 

Minimum Qualifications and Experience:

  • Degree Qualification ideally in a related Automation, Engineering, Computer or other Technical Discipline.
  • 5+ years experience.
  • Effective communication and interpersonal skills to interface effectively with all levels of colleagues in a team environment.
  • Proficiency in Microsoft Office and job related computer applications required.

 

 

9741959 - Senior QA Specialist - Dublin

Purpose:

The Senior QA Specialist for the Bulk Drug Substance (BDS) facility will be responsible, with management support, for providing oversight of quality activities associated with the manufacturing and disposition of bulk drug substances. They are responsible for ensuring that manufacturing, testing, labeling, and storage of Bulk Drug Substances comply with all applicable regulations. This responsibility includes the oversight of the College Park QMS to ensure that quality and compliance requirements are followed in line with business needs. The Senior QA Specialist executes the site QA activities in order to protect the safety, quality and efficacy of our products, thereby ensuring the availability of correct, safe product for our Patients, and assuring the security of the company’s business and global markets. This key role must ensure effective interaction with other departments and locations regarding GMP Document review and finished product releases. In particular, this will involve partnering with major stakeholders such as Operations, QC, QPs, Facilities, Engineering and Supply Chain to optimize patient supply.

Responsibilities:

  • Provide quality and cGMP input and oversight for all NPI project activities through commercial readiness for the facility.
  • Review and approval technical support documentation. (Examples include cleaning, process, method validation.)
  • Review and approval of functional area documentation (SOPs, Work Instructions, technical reports and protocols.)
  • Participate in quality risk assessments and provide quality oversight to ensure quality risk assessments are effectively maintained/ controlled.
  • Provide support and expertise for inspection readiness activities, during health authority inspections including interaction with inspectors, responses to inspection observations, to monitor progress of follow up actions.
  • Responsible for review and approval of Master Batch Records in accordance with company internal procedures and GMP principles.
  • Responsible for review and approval of Master electronic Batch Record recipes in accordance with company internal procedures and GMP principles.
  • Provide oversight of quality management system activities including Preventive Maintenance, Deviation Management and the Change Control Programs.
  • Provide quality oversight of calibration and preventative maintenance criticality assessments as required.
  • Author, review and approve Quality Related Procedures as required.
  • Support the Vendor Management Program.
  • Support the Raw Material Qualification Program.
  • Develop and report quality metrics.

 

 

Minimum Qualifications and Experience:

  • Academic degree in natural or applied sciences (pharmacy, biology, biotechnology, engineering.)
  • Minimum 5 years in international pharmaceutical and/or biotech industry with increased level of responsibility.
  • Sound awareness and understanding of pharmaceutical business, especially with regards to quality and regulatory requirements.
  • Demonstrated success records in auditing and improvement processes.
  • Ability to operate efficiently in a complex matrix organization and international environment.
  • Strong mature leadership and interpersonal influencing skills.
  • Strong verbal and written communication skills with well-structured communication and presentation ability to various audience levels.
  • English fluency written and spoken (the company language.)
  • Efficient in SAP, EMDS, MES and Trackwise.

 

 

 

2020-306 - Engineering Project Manager - Waterford City

Purpose:

This is an opportunity to manage engineering projects and lead engineers while introducing new medical device manufacturing systems and delivering product, cost and quality improvements in a fast-paced environment.

Responsibilities:

  • Create and manage project schedules and budgets.
  • Communicate project information to all stakeholders (across many sites.)
  • Identify, quantify and justify improvement opportunities.
  • Develop requirements documentation for equipment and machine controls software systems.
  • Develop and implement new technologies and systems to support R&D projects.
  • Demonstrate leadership skills to engage team members.
  • Demonstrate team building skills with motivated team members working well together.
  • The role will require travel to the USA and central Europe as project mix varies.

 

Minimum Qualifications and Experience:

  • Bachelor level degree in Engineering or other relevant technical equivalent. Master’s level qualification advantageous.
  • 5-7 years’ experience of project execution and supervision of engineers.
  • Experience with medical device and/or pharmaceutical production required (cGMP / FDA regulated environment.)
  • Knowledge of some of the following: software development life-cycle, GAMP V, SPC, DOE, Statistical Analysis, and Project Management (PMI certification a plus.)
  • Project Management of high volume, low-cost manufacturing systems (may include pneumatics, PLCs, motion control, robotics, HMIs and SCADA.)
  • Capable to lead, motivate engineers and others in project execution.
  • Self-directed. Excellent communication skills.
  • Ability to form relationships with stakeholders from many sites and work within cross functional teams.

 

10264 - Scientific Technical Specialist - Cork

Purpose:

This position will provide technical and validation support to the Vaccine IPT to support the manufacturing and validation of processes for Vaccine IPT to meet the company priorities of: Compliance, Supply, HPO, Strategy and Profit Plan. The Technical Specialist will be required to collaborate and facilitate running of activities (PPQ batch manufacture, validation activities, cleaning validation, requalification, periodic monitoring, investigations, change control) in the Vaccine IPT to ensure the effective and efficient on-time delivery of these activities for the Vaccine IPT. This requires the delivery of technical excellence to deliver components of a stable process, supported by a flexible, collaborative, multi-skilled teamwork environment.

Responsibilities:

  • Ensure the highest Quality, Compliance and Safety standards primarily not only with technical and validation activities but relating to all activities.
  • Work within a team to enable the team’s performance in the Vaccine Technical group within the Vaccine IPT.
  • The Technical Specialist will participate and comply with our Manufacturing Division Quality Management System (QMS) requirements, including ownership, as relevant to you.
  • Provide technical stewardship, equipment resource planning and validation schedules.
  • Responsible for the technical support of manufacture in the Vaccine IPT.
  • Input into technical and validation planning and decisions for the Vaccine IPT, to ensure supply of high-quality product through tactical planning and execution of production schedules.
  • Lead and close process qualification and validation related deviations and reports and participate in problem solving teams across all areas of the Vaccine IPT (e.g. reliability, Safety, Quality (e.g. CAPA/QNs etc.)
  • Protocol/report authoring/execution/oversight/approval as appropriate.
  • Technical review, ownership of and approval of Global Change Management records as required.
  • Cleaning validation activities, Periodic reviews, Requalification of equipment.
  • Recommend technical approaches in line with global and local standards.
  • Contribute for driving a culture of Continuous Improvement by deploying company Six Sigma tools and MPS within the IPT on projects such as: problem solving, reducing cycle time, lean principles within the new processes.
  • Stakeholder management of multiple decision makers, corporate colleagues, cross-functional team by demonstrating the ability to maintain and strengthen trust relationships with people on all levels.
  • Participate and comply with the company Quality Management System (QMS) requirements, including ownership, as relevant.

 

 

Minimum Qualifications and Experience:

  • Degree or Masters in a Science or Engineering discipline (preferably Biotechnology.)
  • 3 years’ experience in biopharmaceutical/vaccines environment.
  • Demonstrated knowledge in pharmaceutical / biopharmaceutical technical / manufacturing operations / validation. Experience of involvement in a technical project is an advantage.
  • Knowledge of regulations and applicable standards for quality, safety, regulatory within the biopharmaceutical/vaccine area.
  • Audit experience.
  • Experience in Validation activities e.g. Cleaning Validation, Requalification.
  • Experience Data Integrity would be an advantage.
  • Preference for Lean Six Sigma qualification or experience of application of Lean principles.
  • Project management qualification such as, Project Management Professional is desirable.
  • Evidence of Continuous Professional Development.
  • Demonstrated knowledge in more than one pharmaceutical or Biopharmaceutical manufacturing operation (e.g. manufacturing, technology, validation, engineering, quality.)
  • Demonstrated ability in holding project team members responsible for results and being decisive about non-performers.
  • Demonstrated ability to realize improvement initiatives.
  • Demonstrated successes in a team environment, such as project teams, Six Sigma team.
  • Demonstrated high level of problem solving and facilitation skills.
  • Advanced PC skills such as Excel, Word, PowerPoint.
  • Stakeholder management of multi decision makers, colleagues, peers and cross functional teams.
  • Experience in an FDA / HPRA Regulated production environment.

 

Associate Director (MPS) - Leinster

Purpose:

As part of the Manufacturing Division, the Manufacturing Systems Design & Commercialization Team is responsible for installing MPS for the new company site. MPS will be embedded into the foundation at start up and become the basis for how we operate. The focus will be on the design and execution of the operating systems, management systems, mindset and behaviors, and capabilities of our people enabling us to produce critical vaccines and biologics medicines at the highest quality, for the lowest cost, and in the shortest lead time. The MPS associate director will work with the IPT leaders and site MPS to design, build and qualify lean systems and processes that directly support manufacturing. Significant time will be spent on the shop floor providing direct, hands on support of activities, with the expectation of coaching leaders and developing MPS capabilities within the organization, implementing local standards used for commercialization and launch activity.

 

Responsibilities:

  • Sponsor and drive a safe-by-choice culture to achieve Target Zero for workplace injuries.
  • Partner with and consult cross-functional groups, plant manager and the leadership team to develop plans and execute lean design for this new facility operations and infrastructure.
  • Develop and install lean management systems and processes for the shop floor through the use of visual factory and Leaders Standardized Work.
  • Build MPS capabilities by executing people development plans and processes.
  • Utilize various lean tools, techniques and global standards to design and install critical business processes and standardized work.
  • Provide teaching and coaching to effectively transfer Lean skills into the organization for the development of Lean Leaders.
  • Sponsor and drive company-owned sustainability goals and actions.

 

 

Minimum Qualifications and Experience:

  • Sponsor and drive a safe-by-choice culture to achieve Target Zero for workplace injuries.
  • Partner with and consult cross-functional groups, plant manager and the leadership team to develop plans and execute lean design for this new facility operations and infrastructure.
  • Develop and install lean management systems and processes for the shop floor through the use of visual factory and Leaders Standardized Work.
  • Build MPS capabilities by executing people development plans and processes.
  • Utilize various lean tools, techniques and global standards to design and install critical business processes and standardized work.
  • Provide teaching and coaching to effectively transfer Lean skills into the organization for the development of Lean Leaders.
  • Sponsor and drive company-owned sustainability goals and actions.

 

 

Senior Microbiologist - Cork

Purpose:

This position requires someone with strong Microbiology experience to provide multidisciplinary expertise and technical support to the Analytical Sciences team and commercial testing laboratories.

 

Responsibilities:

  • Responsible for leading the effective and efficient running of Microbiology Projects both globally and locally, Analytical Method Transfers, Validations, Verifications, Investigations and Change Control.
  • The successful candidate will be a member of the Analytical Sciences Leadership team governing the Analytic Sciences group.
  • Required to demonstrate a high level of technical leadership, collaboration, and coaching to facilitate the team in becoming a high performance organisation and ensuring timely delivery of projects.
  • Active engagement and communication with all internal and external stakeholders.
  • Deliver technical excellence for analytical method stabilisation and process optimisation studies which will deliver and maintain process robustness.
  • Support assay optimisation/investigations within the Microbiology area.
  • Technology Transfer – Preparation of documentation associated with the projects in accordance with GDP (good documentation practice) and site procedures.
  • Lead the delivery of projects whilst adhering to project timelines through the use of project management tools.
  • Lead cross-functional problem-solving teams for troubleshooting, and investigations within local Quality, other our company Sites and contract laboratories as required.
  • Commissioning and Qualification of various lab equipment and design and execution of assay and equipment validation studies and ongoing monitoring.
  • Prepare, review and approval of technical documents, procedures, CAPAs, change control, deviations, metrics, etc.
  • Actively pursue development opportunities to increase the skill set and experience within the group through continuous education, job rotation, cross-functional training, Lean Six Sigma, etc.
  • Collaborate with internal partners (i.e. other sites, R&D) and externally with CROs.

 

 

Minimum Qualifications and Experience:

  • BSc in a relevant Science discipline.
  • Good knowledge of working practices required for working in a Microbiology laboratory (e.g. Bioburden, Endotoxin, Sterility testing etc.)
  • Experience with leading analytical method validations/Verifications.
  • Self-motivated and ability to work as part of a team with good project management skills.
  • High level written and verbal communications with advanced PC skills.
  • Knowledge and experience of operating in a development and commercial lab environment.
  • Desired Qualifications/Experience:
  • D./M.Sc. qualification (Science.)
  • Knowledge of and experience in applying Six Sigma and Lean methodologies.
  • Equipment commissioning and qualification.

 

 

2019-297 - Senior Microbiologist - Waterford City

Purpose:

This role serves both Quality Control and Quality Assurance functions. The primary responsibility will be in the microbiology laboratory sampling, testing and reporting data. QA activities will involve administration end execution of internal control systems such as line clearances, internal audits etc. Also included in the role is responsibility for development and management of QA systems.

 

Responsibilities:

  • Analysis of raw material, in process material and finished products as required.
  • Sampling of materials, utilities and environment.
  • Analysis of utilities and services i.e. water, air, environmental.
  • Participate in method transfer, method development and validation s as required.
  • Ensure that all testing equipment is cleaned, set-up and operated according to Standard Operating Procedures.
  • Perform on-line machine adjustment and trouble-shooting where necessary.
  • Review and assess results and action appropriately e.g. OOS, material Status, deviations, alarms etc.
  • Managing consumables supply within the laboratory.
  • QA Responsibilities:
    • Development, maintenance and implementation of Quality Assurance system to ensure compliance with relevant regulatory requirements. Systems include:
    • In house auditing.
    • Exception and deviation management e.g. CAPA, Non-Conformance etc.
    • Documentation review including Batch records.
    • Supporting quality aspects of materials management including line clearance, supplier approval, supplier complaints, and specification management.

 

Minimum Qualifications and Experience:

  • Qualification in science discipline at primary degree or diploma level. The Qualification must have a high microbiological content.
  • Experience in endotoxin analysis, bioburden analysis, and sterility would be an advantage. Basic techniques e.g. culture transfer, growth promotion are required.
  • Experience in Method validation and method transfer would be an advantage.
  • Aptitude for and/or experience with computer literacy would be an advantage.
  • Experience of scientific report writing including such documents as SOP’s, protocols, deviations, reports etc.
  • Ability to evaluate and access information to determine appropriate risk and required actions is critical.
  • Understanding of pharmacopeia requirements for pharmaceuticals.

 

Clinical Affairs Manager (Veterinary) - Waterford City

Purpose:

To support the Head of Scientific Affairs with clinical activities associated with the registration of company Veterinary products in Worldwide markets with emphasis on US and EU. Manage activities associated with Veterinary Clinical Trials including Target Animal Safety studies, and Efficacy studies for Veterinary projects. To ensure that project plans and milestones are delivered according to agreed timelines.

 

Responsibilities:

  • Project Planning/Co-ordination –
    • Together with the Head of Scientific Affairs and in collaboration with the Regulatory Affairs Manager, actively plan the Veterinary Clinical function requirements ensuring major milestone targets for each product are visible to all team members and key stakeholders to achieve on time market entry.
    • Together with the Head of Scientific Affairs and in collaboration with the Regulatory Affairs Manager, determine tasks and resources required to deliver each project milestone and deliverable.

    Clinical Studies –

    • Design and manage all clinical trials associated with the Veterinary projects including target animal safety and efficacy studies in collaboration with external experts and Clinical Research Organisations.
    • Identify and manage external resources required to ensure completion of the necessary studies to achieve the target milestones. Travel to clinical sites may be required to ensure Sponsor oversight of the studies

    Dossier preparation –

    • In collaboration with the Regulatory Affairs Manager, manage the preparation of relevant dossier sections to support Veterinary license applications including the relevant sections of Modules 2, 4 and 5.

     Leadership

    • Managing a small team of clinical experts to support the Veterinary portfolio development at the company.
    • Coaching/mentoring – support members of team with problem solving and skills development to aid learning and early problem resolution
    • Manage applicable clinical affairs budget and cost centre activities required for veterinary clinical activities.

     Veterinary Business Strategy –

    • Together with the Business Development Manager and relevant technical experts within the company, support existing veterinary partnerships with external partners as well as working to identify new development opportunities for the development of veterinary medicines for the company.

 

Minimum Qualifications and Experience:

  • Bachelor of Veterinary Medicine.
  • Significant clinical practice experience in companion animal space, ideally to include clinical research and in a cGxP environment.
  • Familiarity with cGxP in pharmaceutical manufacturing.
  • Familiarity with concepts of Regulatory Approval process for veterinary pharmaceutical products.
  • Technical knowledge of clinical research in the Veterinary space, with emphasis on small animal practice.
  • Good negotiating skills.
  • Multi-tasking- ability to manage conflicting deadlines.
  • Good planning and organizational skills.
  • Working knowledge of EDMS (Electronic Document Management System.)
  • Ability to understand complex clinical terminology and aptitude to learn new skills in the area of clinical research though working with external experts and CROs.

 

QCQA Chemist - Waterford City

Responsibilities:

  • Sampling and testing of raw materials in-process materials, finished and stability products.
  • Assist at a technical level in out of specification investigation and non-conformance management.
  • Participate in lab process validations, cleaning validations and equipment qualification.
  • Participate in site validations for the process.
  • Involved in ensuring that the laboratory is compliant to regulatory systems.
  • Sampling and testing of materials, utilities and environment.
  • Ensure all operations are conducted in accordance with GMP’s and good scientific principles.
  • Manage documentation and equipment maintenance systems within the laboratory.
  • Review chemical analysis data of raw materials, in process and finish products and assess the results and action as appropriate.
  • Control and management of stability activities including the monitoring of stability chambers.
  • Provide product support by completing line clearances.
  • Involved in updating documents within the site.
  • Support quality aspects of materials management including supplier approval, supplier complaints and specification management.

 

Minimum Qualifications and Experience:

  • Degree in Chemistry with 5 years’ experience in a laboratory environment.
  • Minimum 1 to 2 years’ experience in a regulated pharmaceutical/medical device environment desirable.
  • Experience of method validation and method transfer.
  • Familiarity with OOS management required.
  • Validation experience within a laboratory.
  • Stability experience desirable.
  • Experience in the use of HPLC, GC, FTIR, UV, TOC etc. as well as classical wet chemistry analyses.
  • Full understanding of the requirements of the Regulatory Standards.

 

9444 - Automation Engineer - Carlow

Purpose:

The Project Engineer will work with a team onsite in Carlow and be responsible for the validation of Automation OEM and PC Controlled Laboratory Systems. The candidate will need to have experience in validation and support of Laboratory and/or OEM automation systems/IT applications. The candidate is expected to be self-motivated and develop an understanding of the business. Previous experience of working in a pharmaceutical/GMP environment is essential.

 

Responsibilities:

  • Project oversight from design to hand over to business.
  • Deliver required documentation through the project lifecycle including but not limited to Quality Plans, Requirement Specifications, Tracability Matrix, AIQ, Quality Summary Reports.
  • Conduct validation activities for OEM or Lab systems in accordance with Quality Standards and Practices and GMP guidelines.
  • Work with site QAIT to ensure quality throughout the project lifecycle.
  • Coordinate with various stakeholders from IT/Automation and Business.
  • Configuration of OEM or Lab systems as per requirement specification and building of configuration Specifications
  • Completing risk assessments.
  • Communication and coordination with vendors.
  • Adhere to Data integrity standards.
  • Develop, maintain and keep to project plans and deadlines.
  • Support during commissioning and vendor IQ/OQ testing.

 

Minimum Qualifications and Experience:

  • Experience with OEM or lab system validation.
  • Experience with OEM or lab system administration.
  • Experience with OEM or lab system commissioning and configuration.
  • Experience in regulated GMP environment.
  • Experience of ER/ES and 21 CFR part 11 compliant software desirable.
  • Knowledge of GAMP.
  • Experience working in a Win 10 environment is an advantage.

 

2019-288 - Principal Engineer - Reliability and Maintenance - Waterford City

Responsibilities:

  • Design and optimize maintenance strategies, procedures and methods of work execution.
  • Lead the planning and scheduling of routine maintenance work.
  • Lead A3 project team to resolve repetitive equipment faults or process instabilities.
  • Working with Maintenance/Engineering to optimise planned maintenance routines.
  • Carry out quality inspections on jobs, work execution, identify improvements in tasks.
  • Liaise with client departments, customers and other engineering and production colleagues.
  • Arrange specialist procurement of fixtures, fittings or components.
  • Support the control maintenance costs.
  • Work with specialist equipment, such as programmable logic controllers (EAM, HMI), which control machinery on factory assembly lines.
  • Coach maintenance and engineering excellence strategies to help with installation and commissioning guidelines.
  • Deputize for Maintenance or Engineering Manager on occasion.
  • Support planning and scheduling to minimize impact to HVM operations.
  • Act as key site contact for maintenance excellence initiatives.

 

Minimum Qualifications and Experience:

  • 10+ year’s experience of maintenance related roles in high-volume industries with a significant technology content. Extensive hands-on experience of systems development and deployment, staff engagement and change management. Knowledge of medical device and/or pharmaceutical production preferred (cGMP / FDA regulated environment).
  • Bachelor’s in engineering or other technical discipline preferred. Experience in managing or leading engineering improvement projects, technical or systems related.
  • Knowledge of auto report generation, PLC I/O machine connectivity and equipment or engineering system reliability metrics development advantageous.
  • Experience in EAM/CMMS systems and system development.
  • MRO stores systems experience.
  • Proven ability to support Electronic Asset Management System deployment and technology development.
  • Self-Directed, excellent communication skills on technical subjects. Ability to form relationships with stakeholders from many sites and work within cross functional teams.
  • Experience of building effective MRO stores operating systems, Space management, new technology development for inventory control and cycle counting.
  • Excellent teamworking skills to work cooperatively and liaise with people at all levels.

 

2019-287 - Shift Engineer - Maintenance and Reliability - Waterford City

Purpose:

Improve equipment performance and reliability through technical knowledge and people leadership. This role will include the planning & execution of preventive and reactive maintenance programmes and the leadership of a group of technicians on shift. Technical knowledge & and employee supervision, and development are key aspects of the job.

 

Responsibilities:

  • Implement preventative maintenance programmes.
  • Monitor and drive improvements in the effectiveness of all maintenance activities.
  • Develop training plans for technicians.
  • Own, monitor and report and implement improvements in equipment OEE.
  • Provide details of shortfalls and associated improvement plans.
  • Set goals for the shift technician group.
  • Propose and action projects designed to improve all relevant maintenance KPIs etc.
  • Participate in the recruitment of staff as required.
  • Work with Procurement and Logistics groups on the control of equipment spares.
  • Complete Quality and Safety CAPA activities.
  • Ensure all work is executed in line with health and safety and quality system requirements.

 

Minimum Qualifications and Experience:

  • Education: Bachelor’s Degree in Engineering or other relevant, technical equivalent.
  • Experience: 5+ year’s experience of engineering/ maintenance roles in high-volume industries with a significant technology content
  • 3+ year’s supervisory experience advantageous.
  • Extensive hands-on experience of preventive/ reactive maintenance, technician supervision/ interaction and high-speed automation.
  • Knowledge of medical device and/or pharmaceutical production preferred (cGMP / FDA regulated environment).
  • Knowledge of automatic measurement and reporting of OEE and related production data would be advantageous.

 

9384 - Senior Process Engineer - Cork

Purpose:

Provide process engineering services in support of the design, construction, commissioning and qualification of a new vial filling line. The job-holder works with the company’s Process Engineering Team to act as client owner representative to deliver integrated process engineering services to meet the Project Objectives. The Process Engineer will lead the delivery of a vial wash / tunnel / filler equipment package and will be a key member of a wider team focused on the retrofit of an existing sterile manufacturing facility for a new product.

 

Responsibilities:

  • Support GES Process Lead to implement a Process Design based on the scope of Process Requirements provided by the company Technology Transfer and Process Development Groups.
  • Lead cross-functional project teams to ensure project and site stakeholder inputs and requirements are clear and reflected in design deliverables.
    • Ensure all project stakeholders are informed and consulted on key process suite activities and decisions.
    • Ensure team is delivering to plan against project milestones and provide status reports to project Tiers and stakeholders.
    • Escalate issues, constraints and risks as required
  • Act as client owner representative to self-execute critical design deliverables and provide direction and oversight of design progression by an Architect & Engineering design firm.
    • Ensure IFC Process Flow Diagrams, P&IDs meet process needs.
    • Lead vendor management and equipment testing to verify User Requirement Specifications and Equipment Specifications are met.
    • Manage closeout of process safety deliverables including PHA (Hazops) and machine safety checklists.
    • Ensure company Global and Cork site engineering standards, procedures and practices are followed.
  • Support GES C&Q Lead to coordinate preparation and lead FATs/C&Q field execution.
    • Review and approve system lifecycle documents including Criticality and Risk assessments, FAT documentation, C&Q documentation.
    • Manage installation / start-up / testing of process systems through OQ completion. Interface with cross-functional team to ensure systems’ post-OQ (PQ, PPQ) readiness.
  • Liaise with stakeholders, equipment vendors, business partners, and SMEs at other sites within the company Manufacturing Network as required to support Project.
  • On occasion, the job-holder may also undertake Project Engineering duties including:
    • Preparation of project related deliverables such as schedules, work plans, equipment cost tracking
    • Coordination of project activities between stakeholders

 

Minimum Qualifications and Experience:

  • Minimum qualification B.Sc. or M.Sc./ M.Eng Degree in Engineering, preferably Chemical or Biochemical Engineering or equivalent discipline; equivalent is defined as a Biotechnology or Industrial Chemistry Degree with basic the elements of chemical/biochemical engineering fundamentals as applied to biotechnology/bioprocessing
  • Minimum of 5 years post academic process engineering experience in a biopharmaceutical processing design, construction & start-up environment
  • Demonstrated ability to lead / influence teams in matrix environment
  • Excellent communication/presentation/organizational skills
  • In depth understanding of process engineering and technologies pertinent to unit operations including sterile filling.
  • Knowledge on the application of Disposable Technologies
  • Knowledge of PLC process control platforms and industry SDLC methodology
  • The role will require periods of travel. Flexibility is required in this regard.

 

2019-236 - Senior Regulatory Affairs Specialist - Waterford City

Responsibilities:

  • Support all aspects of the EU Authorised Representative function in Ireland for the company.
  • Deputise for the Regulatory Affairs Manager for all regulatory body communications.
  • Provide EU Regulatory subject matter support to the Vision Care business for key projects and activities.
  • Serve as the person responsible for regulatory compliance for the EU Authorised Representative.
  • Develop and maintain a good knowledge of the Vision Care product portfolio.
  • Verify the EU Declaration of Conformity, Technical Documentation and Conformity Assessment carried out by the legal manufacturer.
  • Maintain the Authorised Representative registration with the Irish competent authority (HPRA) and maintain product registrations for Vision Care products.
  • Submit Field Safety Corrective Action (FSCA) Reports and Field Safety Notices (FSN) in the EEA, Switzerland and candidate countries on behalf of the legal manufacturer.
  • Field questions from competent authorities regarding product performance and/or vigilance and recall on the EU market.
  • Work with the legal manufacturer to provide responses to questions from competent authorities.
  • Participate in notified body and competent authority inspections of Vison Care legal manufacturer and manufacturing sites.
  • Manage the process for provision of certificates of free sale for Vison Care to support maintenance of business and/or market expansion including authentication, apostille and embassy legalization.
  • Upgrade the Authorised Representative policies, procedures and work instructions for EU MDR compliance.
  • Provide advice regarding interpretation of MDD 93/42/EEC and MDR 2017/745 including associated guidance (e.g. Meddev, Common Specifications etc.).
  • Support key EU MDR work streams (e.g. economic operators, technical files, quality systems).
  • Contribute to discussions internally and with notified body and competent authorities.
  • Willingness to travel on company business 10-15% of time.

 

Minimum Qualifications and Experience:

  • Minimum bachelor’s Degree BS in an engineering or scientific discipline or a Master’s degree MS in regulatory affairs or a related discipline.
  • 4-5 years’ experience in regulatory affairs.

 

2019-234 - Engineer - Process and Equipment - Waterford City

Description:

This position is to support manufacturing systems. Technical expertise is required to maintain, develop, debug and troubleshoot process & equipment issues.

Responsibilities:

  • Develop and implement process and equipment improvements with minimal impact to production operating under 24/7 environment.
  • Identify and eliminate repetitious machine failures.
  • Provide support to the Manufacturing, Maintenance, and Equipment Design groups.
  • Utilise Lean Six Sigma tools along with data to drive continuous improvement. Objective to minimise scrap, increase yield, reduce turn-around-time, minimise manufacturing downtime and costs and ensuring quality manufacturing within given specifications
  • Developing a detailed understanding of the process and automation systems in the manufacturing process, and sharing of technical expertise with colleagues.
  • Develop methods to ensure personnel engaged in maintenance activities have sufficient knowledge to perform their assigned tasks.
  • Generate documentation and SOPs associated with each of the equipment or process systems as required
  • Present, where appropriate, technical data to internal/external audit and inspection groups.
  • Ensure highest level of Health and Safety is considered and adhered to at all times for self and others
  • Equipment installation and validations
  • Process \ Equipment Engineers may lead projects \ project teams

Minimum Qualifications and Experience:

  • Bachelors in Engineering (mechanical\electronic) preferred.
  • A minimum of 4 years in technical role in high volume manufacturing environment preferred.
  • Good problem solving abilities – able to identify facts, consider alternative approaches and evaluate the most appropriate action.
  • Six sigma experience preferred.
  • Medical device and/or pharmaceutical industry experience preferred
  • Experience working in a validated environment with strong discipline with regard to change control is preferred.
  • Ability to share technical expertise with colleagues, must be able to express information clearly and concisely both verbally and in writing

 

2019-232 - Engineering Project Manager - Waterford City

Description:

Engineering Project Manager is responsible for the leadership of engineers and Project Management for new medical device manufacturing systems, products and cost improvements.

Responsibilities:

  • Use skills of analysis to identify, quantify and justify improvement opportunities.
  • Develop URS documentation for equipment and machine controls software systems.
  • Develop and implement new technologies and systems to support R&D projects.
  • Create and manage project schedules and budgets.
  • Communicate project information to all stakeholders (across many sites).
  • Identify, manage and mitigate project risk.
  • Identify and resolve project issues.
  • Demonstrate leadership skills to engage team members.
  • Demonstrate team building skills with motivated team members working well together.
  • Job will require travel to the USA and central Europe as project mix dictates.

Minimum Qualifications and Experience:

  • Bachelor level degree in Engineering or other relevant technical equivalent. Master qualification advantageous
  • 10+ years’ experience of project execution and supervision of engineers
  • Experience with medical device and/or pharmaceutical production required (cGMP / FDA regulated environment)
  • Knowledge of some of the following; software development life-cycle, GAMP V, SPC, DOE, Statistical Analysis, and Project Management (PMI certification a plus)
  • Project Management of high volume, low-cost manufacturing systems (may include pneumatics, PLCs, motion control, robotics, HMIs and SCADA)
  • Capable to lead, motivate and access engineers and others in project execution and technical development work streams
  • Self-directed. Excellent communication skills. Ability to form relationships with stakeholders from many sites and work within cross functional teams

 

Senior Project Coordinator (Project Manager R&D) - Clonmel

Responsibilities:

  • Responsible for compliance with applicable corporate and divisional policies and procedures. Estimates project levels of effort and resource requirements by using standard estimating techniques and tools, and by working with appropriate staff to understand scope of effort.
  • Prepares project plans, schedules and budgets by using project management tools such as Microsoft Project and by working with appropriate staff to understand tasks necessary to complete project.
  • Directs project execution by assigning tasks, tracking project schedules, identifying risks, and developing and executing contingency plans.
  • Assures project quality by using standard development methodologies and by working with the Supplier Quality Associate (SQA) to develop and execute project quality plans. Communicates project status by preparing standard status reports, and by participating in departmental and customer project status update meetings.
  • Resolves project issues by working with team members, project customers, and others as appropriate.
  • Participates in external project management organisations, conferences and seminars to keep current with industry best practices in project management by joining professional associations and implementing a professional development plan with focus on project management.

Minimum Qualifications and Experience:

  • National Framework of Qualifications level 7 qualifications in a relevant discipline.
  • 4+ years of related work experience or an equivalent combination of education and experience

 

2019-225 - Senior Molding Engineer - Clonmel

Description:

Plays a leading role in the area of injection molding related activities, including new tool qualifications and resolution of supply and quality issues encountered during day-to-day running of the business.

Responsibilities:

  • Responsible for design, development, implementation and ongoing support of polymer-based injection molded components used in the manufacture of our client’s products offerings.
  • Serve as both technical expert in the field of injection molding as well as a project manager for molding related projects, working regularly with Research and Development (R&D), Operations, Supply Chain, Quality and suppliers.
  • Manage molded commodities over life cycle including tactical and strategic activities to support ongoing business such as product, process, quality and cost improvement initiatives, supplier and resin changes, material obsolescence.
  • Troubleshoot molding issues in conjunction with supplier and lead/support internal investigations as required.
  • Work closely with molding suppliers to ensure reliable supply of parts.
  • Responsible for ensuring adherence to quality system through creation and update of specifications, metrology, setup, design control and qualification and Failure Models and Effects Analysis (FMEA)
  • Identify critical dimensions and work with suppliers to ensure proper process controls are in place.
  • Must have proven ability to participate in team atmosphere, exhibit and create a sense of urgency and maintain effective working relationships with peers, customers and suppliers.
  • Concurrent management/support of multiple projects.
  • Create and maintain project schedules, lead and participate in cross-functional team activities to achieve program objectives.
  • Transfer of molds to new suppliers, start-up of new suppliers.
  • Participate in cross-functional teams to investigate and resolve molding issues.
  • Perform capacity analysis for molds, presses and assembly automation and make recommendations for future investment.

Minimum Qualifications and Experience:

  • Experience/Education
  • National Framework of Qualifications (NFQ) Level 7 qualification in a relevant discipline
  • 4+ years of relevant work experience or an equivalent combination of education and work experience.
  • Technical/Business Knowledge (Job Skills)
  • Wide application of technical principles, practices and procedures within the field of polymer component manufacture, in particular within the field of injection molding. Strong understanding of business unit functions and cross group dependencies/ relationships. Will perform role within quality system environment. Failure to adequately perform tasks can result in noncompliance with governmental regulations.
  • Cognitive skills
  • Works on problems of diversive scope where analysis of data requires evaluation of identifiable factors. Exercises judgment within generally defined practices and policies in selecting methods and techniques for obtaining solutions. Has a sound knowledge of various technical alternatives and their impact.
  • Influence/Leadership
  • Establishes and cultivates an extensive network of support to facilitate completion of assignments. Participates in the development of less experienced staff by setting an example, providing guidance and work direction, and offering counsel. May lead a project team. Participates in determining goals and objectives for projects. Influences middle management on technical or business solutions. Interacts frequently with suppliers.
  • Planning/Organization
  • Plans and organizes non-routine tasks. Initiates or maintains work schedule. Establishes priorities of work assignments.
  • Decision making/Impact
  • Exercises judgment in selecting innovative, practical methods to achieve problem resolution. Failure to obtain results or erroneous decisions or recommendations would typically result in serious program delays and considerable expenditure or resources.
  • Supervision Received
  • Works under only general direction. Independently determines and develops approach to solutions. Work is reviewed upon completion for adequacy in meeting objectives.
  • Supervision Provided
  • May provide work direction and guidance to exempt and/or skilled non-exempt levels of employees; may be asked to evaluate performance of and assist in career development planning for subordinates.

Senior Quality Engineer (R&D) – Waterford City

Description:

Ensure that all required Quality systems are implemented and effectively operating in the R&D development Lab. Ensure that all R&D project activities are carried out in compliance with the requirements of Quality Systems, FDA and other regulatory agencies up to and including Process validation. Provide oversight for Design Management of contact lenses – from a Quality System and technical perspective. Provide Quality Support to Manufacturing Plant as required.

Responsibilities:

  • Support Development Lab activities from a quality systems perspective
  • Implement and effectively maintain compliance with regional directives and procedures across R&D activities
  • Review and approve all protocols and reports for R&D equipment qualifications
  • Review and approve all protocols and reports for the manufacture of Clinical Trial Materials
  • Review all batch history records for clinical trial materials prior to issuing QA Release memo
  • Provide Regional Quality support for all Design Control activities
  • Drive and oversee all Risk Management activities for new product development
  • Complete and provide Risk Management and Complaint data updates to Annual Product Quality
  • Reviews and for revision of Design Risk Analysis and Clinical Evaluation Reports
  • Review and approve all Process Validation protocols and reports for new products

Scope of Position:

  • Ensuring that Quality systems are effectively implemented and maintained in Waterford R&D
  • Ensuring Compliance with quality standards and GMP requirements for all product/ process development activities in the R&D program of work through participation in R&D process development teams and approval of protocols.
  • Regional Quality support for all Contact Lens development projects in Waterford from inception to successful technology transfer / scale-up.
  • Risk management activities through development and product lifecycle.

Minimum Qualifications and Experience:

  • Bachelor degree in Science or Engineering
  • Certified training in Quality Systems Requirements of FDA and ISO-13485
  • Certified training in Auditing of Quality Systems
  • Documented training in all relevant company Directive and Procedures
  • 5+ years relevant experience in a similar industry