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

2020-329 - Financial Accountant - Waterford City

Purpose:

The Financial Account (‘FA’) position is a key position within the organisation, being responsible for the financial reporting within the company, working with the management team and across all business units and reporting to the Financial Controller.

Responsibilities:

  • Ensure that the books and records of the organisation are maintained accurately and in a timely manner in accordance with Irish & US GAAP.
  • Maintain the Chart of Accounts.
  • Ensure month end is closed off and next month is opened in a timely manner.
  • Responsible for R&D project accounting and tracking of R&D spend.
  • Business Partner to Project Managers.
  • Provides support for lean and cost improvement initiatives.
  • Leading grant submission claims.
  • Project work as required.
  • Financial reporting:
    • Prepares monthly, quarterly and annual management accounts. Responsible for completing the financial reporting template supported by appropriate documentation and records which are in compliance with SOX.
    • Compile statutory accounts.
  • Tax compliance:
    • Assist with the Quarterly tax return requested by Corporate.
    • Assist with the completion of the annual Corporation Tax and R&D tax credit computation.
  • Annual audit:
    • Assist in the delivery a clean opinion for US & Irish GAAP accounts.
    • Assist in the delivery of internal controls (SOX) audit.
  • Budgeting and forecasting:
    • Supports the annual budgeting/3-year plan process across the organisation along with forecasting requirement.
    • Supports the monthly forecasting requirements set out by Corporate.
  • Cash flow and working capital management:
    • Ensuring cashflow and working capital is monitored and managed internally.

 

Minimum Qualifications and Experience:

  • Professional Qualification at the level of CIMA/ACA/ACCA.
  • 2/3 years post qualification experience.
  • Strong analytical abilities.
  • Experience using ERP software packages.
  • Good communication and team building skills.
  • Detail oriented with extreme accuracy.
  • Extensive spreadsheet analysis knowledge and strong mathematical abilities.
  • Ability to work and lead when required cross-functionally.
  • Collaborative skills in resolving customer, partner and internal challenges/issues.
  • Diplomacy.
  • Patience.

 

 

2020-328 – QA Specialist - Waterford

Purpose:

Reporting directly to the Quality Assurance Team Leader, as a critical leader for the company, you will play an integral role in providing day to day Quality and compliance support to the sterile manufacturing operations.

Responsibilities:

  • Review and approval of deviation, CAPA’s, quality events and tasks.
  • Provide QA support to Change management within the Waterford Laboratories.
  • Ensure the quality system at the company is effectively implemented and maintained.
  • Perform timely review of documentation / investigations / reports highlighting and assisting in the resolution of concerns commensurate with the risk.
  • Actively contribute to continuous improvement initiatives.
  • Conduct duties in a safe manner and report all safety issues or concerns.

 

Minimum Qualifications and Experience:

  • Bachelor’s degree in a science related subject is essential.
  • 3 years’ experience in a Quality Assurance role is preferable.
  • Operational experience of quality systems in a dynamic manufacturing environment.
  • 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.
  • Must be able to respond quickly to unplanned events, technical issues and changing needs from development programs.
  • All applicants must be open to shift work.

 

 

11120 – Regulatory Affairs Specialist - Dublin

Purpose:

This role represents an excellent opportunity to be part of the commercial regulatory affairs environment of the company. The primary objective of the role is to obtain and maintain veterinary medicinal product marketing authorisations in line with business and legal requirements in the Republic of Ireland. This role is responsible for undertaking a variety of regulatory activities for a range of veterinary medicinal products.

Responsibilities:

  • Submission of new marketing authorisation applications, management and maintenance of existing marketing authorisations via submission of applications to vary marketing authorisations, submission of renewal applications, and other submissions to ensure regulatory and market compliance in Ireland.
  • Generation, maintenance and control of product literature approvals (labelling text and packaging artwork) in line with regulatory requirements and company labelling artwork approval systems.
  • Coordination of communication with global regulatory and European licensing team colleagues to ensure appropriate documentation is supplied to the regulatory authorities within appropriate timelines.
  • Communication of marketing authorisation change approvals to ensure efficient and compliant change implementation.
  • Provide internal advice and expertise on all regulatory matters in support of support of business objectives.
  • Supporting and maintaining local company regulatory and quality compliance systems.
  • Some GDPR responsibilities are part of this role.

 

Minimum Qualifications and Experience:

  • A degree in a discipline that is relevant such as a life-sciences degree or suitable alternative such as veterinary science or pharmacy or related subject matter.
  • Experience in regulatory affairs.
  • Experience in a commercial regulatory environment would be considered an advantage and is preferred, but not essential.
  • Excellent computer skills are essential. Sound working knowledge of Microsoft Office 2010 applications and ability to work in/with a variety of customised applications.
  • Excellent verbal and written communication skills, with the ability to interact with a wide range of people both internal and external, including regulatory authorities.
  • Meticulous approach and attention to detail.
  • The ability to work to challenging deadlines and managing conflicting priorities.

 

 

10908 - Quality Specialist - Tipperary

Purpose:

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 facility.
  • 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.
  • 1-3 years’ experience.
  • 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.

 

 

2020-327 – Statistician – Waterford City

Purpose:

Site SME to lead the development of site statistical systems, to lead the training of engineering and quality personnel in the use of these systems and in supporting their subsequent use on site. Enable site engineers, chemists & scientists in designing and deploying systems to transform data into useful process information. Support the expansion of current business and introduction of new drug product platforms across the site from a statistical perspective. Champion & Lead statistical best practices across the site. This is a very autonomous role that requires working with individuals/teams across all site departments on various stats related projects/investigations/continuous improvement initiatives. There is a high level of responsibility with this role, as the site SME on statistical techniques, to ensure data driven decisions are robust and can be defended in an audit scenario. Due to the site wide scope of this role, the day to day activities are very dynamic, interesting and challenging. Collaboration with the global statistics team provides a peer group to consult with on high profile topics, while offering the opportunity for development. The Statistician is an individual contributor role with no direct reporting responsibilities, but the ideal candidate must be able to lead project teams independently.

Responsibilities:

  • Provide statistical guidance for method validations and method transfers in the areas of accuracy, precision, linearity, equivalence testing (TOST,) power and sample size.
  • Support major process engineering and/or quality investigations from a statistical perspective to ensure data is available to provide focused information as part of the problem-solving processes.
  • Support the roll out of statistical process control (SPC) across the manufacturing platforms to promote equipment and product reliability.
  • Evaluate the statistical methods and procedures used to obtain data to ensure validity, applicability, efficiency, and accuracy.
  • Analyse and interpret statistical data to identify significant differences in relationships among sources of information, e.g. use statistical tools to demonstrate comparability for process transfers.
  • Develop and test experimental designs, sampling techniques, sampling plans and analytical methods.
  • Examine theories, such as those of probability and inference, to discover mathematical bases for new or improved methods of obtaining and evaluating numerical data.
  • Deliver statistical training to engineers/scientists/quality personnel, specifically in the use of Minitab and JMP statistical software.

 

Minimum Qualifications and Experience:

  • Bachelor’s, Master’s, or PhD degree in Statistics, Biostatistics, or Applied Math.
  • Minimum of 2 years prior work experience in Statistics for those with only a Bachelor’s degree.
  • In lieu of a degree in Statistics, Biostatistics, or Applied Math, individuals with 4 years prior work experience as a Statistician or Biostatistician in a related industry may also be considered for a Statistician position.
  • Excellent understanding of the applications of statistics in a manufacturing environment.
  • Experienced user of statistical analysis packages, particularly Minitab and JMP.
  • Familiar with regulatory statistical expectations.
  • Excellent problem solving and data analytical skills.
  • Strong influencing, communication and interpersonal skills.
  • Strong ability to coach and mentor others across departments.
  • Flexible with the ability to prioritise work in a dynamic environment.
  • Effective change agent and ability to manage resistance to change.

 

 

11049 – QC Raw Materials Analyst - Dublin

Purpose:

The QC Raw Material Analyst role is a critically important activity to ensure efficient and effective compliant design, construction, qualification, and operation of the new company facility. This tremendous opportunity will be responsible for verifying the raw materials analytical methods and performing supplier qualification. 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. To maximize the development opportunity, the candidate will be the key talent in analytical raw materials techniques and in Pharmacopeia methods. The facility will utilize the latest innovations in technology and automation and latest in analytical technics. The candidate will work with a high performing cross functional team of talent sourced from across the company and the biotechnology industry. The candidate will be actively supported and encouraged to continue their development and knowledge build, incorporating areas to support their future development and ability to continuously improve in their current role. The candidate will provide support to other analysts within the lab area, including training and guidance on their area of expertise. The full analytical scope will incorporate micro, chemistry, 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 have responsibilities in analytical transfer and qualification of methods.

Responsibilities:

  • Perform supportive activities for general lab readiness, laboratory equipment qualification and method transfers.
  • Perform and carry out a variety of routine analytical techniques including but not limited to HPLC, HIC, CE, IEX, HP-SEC, UV, pH, Colour, Osmolality, Degree of Coloration and Appearance in compliance with GMP requirements.
  • Follow up-to-date analytical practices with reference to pharmacopoeias, specifications, regulations and industry standards.
  • Support the laboratory testing schedule to achieve an efficient QC system.
  • Receive and manage samples that come into the lab for stability, in-process and release testing.
  • Solution preparation, cleaning, routine equipment maintenance and system set-up.
  • Writing and update of SOPs.
  • Maintain good housekeeping and hygiene within the laboratory.
  • Calibrate and maintain all designated laboratory instruments.
  • 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 programs.
  • Participate and Comply with the company Quality Management System requirements.
  • Responsible for driving a culture of Continuous Improvement by deploying company Six Sigma tools.
  • Possibility of shift work.
  • This position will be on days with the possibility of shift work when required.

 

Minimum Qualifications and Experience:

  • Degree qualification (Science/Quality/Technical). Master preferred.
  • 1-3 years industry experience with significant knowledge and experience in working in a Raw material lab unit and working with contract labs.
  • Experienced in testing as per the pharmacopeia.
  • Working knowledge of QC Systems (Empower, elogs, Electronic Lab Notebook, LIMS.)
  • Preference Lean Six Sigma.
  • Good verbal and written communication skills
  • Ability to think logically and be proactive.
  • Ability to work as part of a team and on own initiative in a constructive manner.

 

 

11038 – Project Coordinator - Carlow

Responsibilities:

  • Ensuring full and robust integration of the Pre OQ schedule phases into the Post OQ Schedule.
  • On-going review and implementation of the Post OQ schedule strategy as determined by Post OQ management.
  • Ability to fully resource load Post OQ schedule & generate planned resource requirements per department.
  • Implement and Manage Planned vs. Actual earned value from the Post OQ schedule.
  • Compilation and issue of weekly and monthly schedule progress reports & graphics.
  • Management of progress updating interface with Post OQ team weekly and monthly.
  • Ensuring on-time delivery of schedule deliverables.
  • Planning, preparation and facilitation of key schedule workshops and communications.
  • On-going liaison with the Project Manager regarding schedule issues.
  • Attendance and input at Post OQ progress meetings.

 

Minimum Qualifications and Experience:

  • Minimum of a third level degree in a relevant discipline.
  • 8 years’ experience In Planning / Scheduling with at least 3 years’ experience on Fill Finish Projects (Ideally in a Post OQ Role.)
  • Good communication & people skills.
  • Be able to work as part of a team & independently.
  • Excellent time management skills.
  • Self-starter and decision maker.
  • Excellent with Primavera and MS Project.

 

 

9999574 - Technical Service Specialist – Downstream - Dublin

Purpose:

The Technical Specialist – Cell Culture, 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 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, Global Technical Operations, Engineering, Regulatory, QC and Quality to provide support of manufacturing of BDS. Previous experience of a technology transfer in a cell culture capacity, cleaning validation and exposure to raw materials oversight setting is advantageous.

Responsibilities:

  • Provide process information and analysis to facilitate process 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.
  • Undertake technical risk assessments to support raw material assessment for NPI, update to Mass balances; development of materials listing/BOM’s to support process.
  • Identify technical issues, and guide resolution of same.
  • Provide SME knowledge and understanding in BDS manufacturing processes (upstream); cause and effect, scale up principles, and process validation strategies.
  • Shape and develop strategy approaches for Technical Services in areas such as downstream purification processes, technical studies supporting process 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.
  • Provide SME support for the area on key audit topics.
  • Collaborate with Global Technical Operations and Engineering to implement site specific process control strategy, complete process risk assessments and associated documentation to support equipment qualification activities, Technical supporting studies and concurrent and prospective validation studies and key technical strategies.
  • Undertake QRM risk assessments 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.
  • Requirement to work periodically out of normal business hours (temporary shift working or per out of hours policy) during periods of shakedown/engineering and validation batch execution, and participation in on-call roster.
  • Short duration Person in Plant (PIP) observation may be required at sending units/existing facilities to support Tech Transfer into the facility.
  • 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, 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.

 

 

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 2-3 years+ experience in a pharmaceutical manufacturing organization, with expertise in Bulk Drug Substance manufacturing, with previous experience in cell culture unit operations, process/facility fit, New Product Introduction Technology Transfer. Previous experience of a technology transfer in a cell culture capacity 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.
  • Understanding of analytical methods and interpretation of results with impact to the process.
  • Understanding of technology transfer and bioreactor scale-up process.
  • 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.
  • 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.
  • Detail orientated.
  • Technical writing competency.
  • Demonstrated ability to drive for results and lead innovation and change.
  • Self-driven, able to prioritize, and to orchestrate multiple activities at once.
  • Strong Team Player.

 

 

9925369 - Technical Service Specialist – Upstream - Dublin

Purpose:

The Cell Culture (Upstream) Technical Specialist has primary responsibility in supporting the startup and cGMP manufacture of biological bulk drug substance (BDS.) The Technical Specialist will be part of the cell culture team to support the facility start-up and routine commercial manufacturing from small scale and large scale media preparation, vial thaw, through typical scale up processes, to seed and production bioreactors, with harvest and clarification technologies respectively. The Technical Specialist will be responsible for providing support for technology transfer of new/existing drug substance (DS) manufacturing processes to the Dublin facility, and will be required to work in close collaboration with Process Development, Operations, Engineering, Quality, Quality Control, Regulatory and other involved departments to ensure successful facility startup and process qualification. The position is accountable for timely completion of technical transfer related milestones, with particular emphasis on new product introduction, Technology Transfer, supporting start-up studies, building process data packs and performing process monitoring, study protocol generation, execution and report writing.

Responsibilities:

  • To provide technical process support in the area of media preparation, large scale cell culture bulk drug substance manufacturing process (vial thaw, scale up, seed reactors and production bioreactors) to support the successful startup of the company’s facility in Dublin.
  • Working knowledge of typical cell culture unit operations, cause and effect, collation of data and trends. Performing process monitoring/trending.
  • To author and review process supporting documentation, gap assessments, technical protocols and reports, process validation documentation, strategy documents.
  • To support the introduction of new raw materials and consumables through the generation of materials lists, Bills of Material updates, material specifications.
  • To work closely with colleagues in Quality, Supply Chain and Manufacturing Operations to ensure availability and release of materials to meet technology transfer and routine manufacturing timelines.
  • Partner with Operations to support protocol completion, execution and sample reconciliation.
  • To generate documentation reports for plant supporting studies and technical studies on the manufacturing floor at commercial scale.
  • May be required to work periodically out of normal business hours (temporary shift working) during periods of engineering and validation batch execution, as well as any other duties as required.
  • To provide on the floor support for troubleshooting processing issues and to participate in closeout of manufacturing investigations into process deviations and resolution.
  • Lead any key process changes using change control management system as required.
  • Adherence to highest standards for Compliance (Quality and Safety), implement corporate standards and liaise effectively with global groups and provide technical support during audits.
  • Ensure compliance with site EHS policy, cGMP and other business regulations and participate in risk assessments, audits and incident investigations.

 

 

Minimum Qualifications and Experience:

  • Minimum requirement would be B.Sc. in Biochemistry, Biology, Chemistry or equivalent, or B.Eng. Process or Chemical Engineering. A higher degree (M.Sc. or Ph.D.) would be an advantage.
  • Minimum 1-2 years’ experience in Technical Services / Process Development / Manufacturing Support in a biological bulk drug substance manufacturing organization.
  • Technical and operational knowledge of multiple unit operations in upstream processing, including media preparation, mammalian cell culture, centrifugation & depth filtration.
  • Understanding of technology transfer, scale-up process and cleaning verification/validation is advantageous.
  • Understanding of cGMP requirements for commercial biopharmaceutical manufacturing and the ability to implement best practices to ensure multi-product bulk drug manufacturing operations are cGMP compliant.
  • Good interpersonal skills coupled with demonstrated ability to effectively work in a matrix organization, and in local group settings.
  • Ability to present and defend technical and scientific approaches in both written and verbal form.
  • Ability to drive for results independently and adapt to rapidly changing priorities.
  • Detail orientated.
  • Technical writing competency.
  • Self-driven to do the right thing.
  • Enjoy a fast-paced working environment with broad levels of engagement and insight for self-development and experience gain in a startup environment.

 

 

9940266 - Customer Operations Specialist (Customer Service) - Dublin

Purpose:

Specialist responsible for ensuring that the team efficiently handles customers’ enquiries such as purchase orders, vial requests, complaints for lost or damaged goods, product returns or exchanges. Work with the Customer Operations manager to ensure that training is adequate to professionally answer incoming calls and emails, understand the customers’ needs and their environment, and to improve satisfaction at sales and service support levels. Work to build strong customer relationships through proactive communication and customer facing key performance indicators plus drive regular customer business reviews. Maintain the accurate and timely processing of all orders and requests in SAP. Build excellent working relationships and regular contact with stakeholders such as Sales, Finance, Credit Management, Distribution, QA, Regulatory and Contracts. Support the Customer Ops manager in process improvements, Customer Operations specific projects and initiatives. Fully understand all of the Departmental processes and consistently seek out areas and opportunities to improve overall team efficiency in alignment with local requirements and the Customer Operations manager. Drive superior levels of compliance and efficiency with all tasks within the Dept., always ensuring every patient is treated on time every time.

Responsibilities:

  • Provide support to the Customer Operations manager in the management of the core Customer Operations tasks on a daily basis.
  • Provide regular reporting and feedback on the challenges of the day/week, and take the initiative to proactively solve issues or reach out to other Depts. for support required.
  • Provide backup and cover for the team and their customers in the case of the absence of the manager.
  • Accountable for using and maintaining established & Standardized template(s) / Document(s) / procedure(s) whenever it is applicable, in conjunction with Regional Customer Operations Snr. Manager’s guidance/recommendations and ensuring all team members are trained and compliant against same at all times.
  • Work to facilitate strong and efficient points of contact between team members and all the existing and new Customers.
  • Daily monitor and manage sales orders, rush orders, service requests and advance exchange programs with the team members (Shipping Calendar processing, etc. for both Commercial, Free of Charge/Compassionate items) Ensure all received orders are always processed by end of Business Day.
  • Support the manager to ensure Customer Business Reviews and Business Performance metrics drive best-in-class Supply Chain service to company customers.
  • Provide follow-up and solutions to customers and sales team regarding order status, product availability, shipping information, damaged or lost product. Manage the coordination of information to the customer and to the internal teams on all aspects of the order processing role. This includes all shipment status updates by Distribution.
  • Monitor closely with the Distribution team to ensure that product is delivered to the right place, at the right time and for the right patient.
  • Vaccination certificates (CoV) checking: collection, and working with medical and regulatory people in the regions in order to approve CoV, entering the information into the SAP database.
  • Ensure the follow up of the re-vaccination process by liaising with the field; make sure all information is captured.
  • New Customer Creation and modification in accordance with the appropriate control documents.
  • Ensure the highest self-adherence to all compliance requirements within the function;  Quality control – Good Distribution Practice (GDP Guidance.)
    • Data Privacy control – General Data Protection Regulation (GDPR.)
    • Financial control – Sarbannes Oxley.
    • Regulatory control – Controlled distribution.
  • Assist and execute all C.Ops activities as per SOPs for product Recalls, in close collaboration with Distribution and QA Teams.
  • Manage Customer Pre-payment processes in conjunction with current SOP and the company’s Credit Management policy. Manage: traditional and electronic Invoice Management, pre-payment and invoices not paid, late payment interest.
  • Ensure that all external inquiries from prospective and current Customers are dealt with in a timely and professional manner by the team.
  • Effectively and efficiently manage project items as assigned by the Snr. C.Ops Manager and deliver on timelines and tasks as required and in accordance with project dates.

 

 

Minimum Qualifications and Experience:

  • University Degree in Business Related or Supply Chain preferred.
  • GDP Certification.
  • Previous Pharmaceutical Experience essential, minimum of 2 years ideally in a Customer Service or Supply Chain function.
  • Fluency in English language both written and oral is a requirement.
  • Fluency in one other European language, both written and oral, is also a requirement.
  • Additional ‘other’ language skills would be desirable.
  • Strong knowledge of SAP and systems.
  • Excellent communication and relationship building skills.
  • Knowledge of Supply Chain Operations beneficial.
  • Strong computer literacy, with MS Office (Word, Excel, Outlook, Power point.)

 

 

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.

 

 

10451 – Validation Engineer - Cork

Purpose:

This position will provide expert technical support to the Vaccines IPT for the Qualification, Validation and Technical activities for Vaccines IPT manufacture. The Validation/Technical Specialist will be required to lead and collaborate across functional teams on site on the qualification/requalification utilities and equipment; manage external vendors for the provision of qualification services and support the operationalization of the company quality standards within Vaccines IPT. The successful candidate is accountable for supporting all technical components to deliver an effective and efficient Vaccines IPT.

Responsibilities:

  • Ensure highest Quality, Compliance and Safety standards are adhered to.
  • Protocol/report authoring/execution/oversight/approval as appropriate.
  • Recommend technical approaches in line with global and local standards.
  • Ensure supply of high quality product through ensuring equipment availability; maximize team member performance through continuous process improvement initiatives.
  • Benchmark and remain current with development of new technologies in the vaccine and biopharmaceutical processing field of expertise and seek to deploy process improvements through innovation and utilization of these technological advances.
  • Participate in problem solving teams across all areas of the Vaccine IPT.
  • Support process related deviations and reports.

 

Minimum Qualifications and Experience:

  • Degree or Masters in a Science or Engineering discipline.
  • Minimum 6 years’ experience in a regulated manufacturing environment.
  • Demonstrated knowledge in validation and other pharmaceutical or Biopharmaceutical operations (e.g. manufacturing, technology, engineering, quality, analytical.)
  • Previous experience of delivering technical/validation projects.
  • Understanding of temperature mapping activities, requalification requirements of equipment, periodic reviews of equipment, autoclave and SIP requirements.
  • Knowledge and understanding of the requirements around sanitization and sterilization processes.
  • Understanding of Computer Systems Validation (DeltaV knowledge preferable but not essential.)
  • Good working knowledge of Data Integrity Requirements.
  • Demonstrated process qualification and validation SME background within the pharmaceutical or Biopharmaceutical industry.
  • Demonstrated capability to deliver results RFT, in a FDA / HPRA Regulated production environment.
  • Demonstrated high level of problem solving and facilitation skills.
  • Working and collaboration across multiple functional teams.
  • Change management skills.
  • Preference for Lean Six Sigma qualification or experience of application of Lean principles.
  • Project management qualification such as, Project Management Professional is desirable.

 

 

11029 – EHS Specialist - Tipperary

Responsibilities:

  • Participate in project design reviews and HAZOPS for proposed new systems.
  • Ensure management of change processes are followed and serve as EHS reviewer for planning of activities impacting existing facility operation.
  • Co-ordinate project support from relevant SME’s such as Industrial Hygiene, Process Safety, Machinery Safety etc.
  • Support the containment philosophy for the potent compound facility.
  • Serve as a site EHS representative during mechanical completion, commissioning and qualification activities, participate in project walk-downs and start-up activities for assigned systems:
    • Ensure that installation is in conformance with local and national regulations, internal company standards, design intent and HAZOP recommendations.
    • Ensure that all necessary procedures, PPE, signage and training are complete and available for performing the necessary tasks during the specific start-up phase.
    • Serve as primary EHS reviewer for Pre-Start-up Safety and Environmental checklists completed during project start-up activities.
  • Serve as a leader in demonstrating and implementing a strong EHS culture across the project.
  • The successful candidate will be able to demonstrate a proven track record to influence others, have strong knowledge of safety programs and be a convincing communicator with strong interpersonal skills. The ideal candidate is a self-directed, technically strong individual who can work in a multi-functionary team environment.

 

Minimum Qualifications and Experience:

  • Bachelor’s degree in Engineering or related Safety or Environmental field of study.
  • +5 years of EHS, Engineering, or Operational experience in chemical, pharmaceutical, biochemical, petrochemical or process related industry.
  • Drive to engage others and have excellent interpersonal, communication and leadership skills.
  • Ability to maintain focus on key project goals and priorities, but also analyse the detail to facilitate problem resolution and ensure project success.
  • Knowledge and experience working with EHS regulations.

 

 

10638 – Validation Specialist - Cork

Purpose:

This position will provide expert technical support to the Vaccines IPT for the Qualification, Validation and Technical activities for Vaccines IPT manufacture. The Validation/Technical Specialist will be required to collaborate across function teams on site on the qualification/requalification utilities and equipment; manage external vendors for the provision of qualification services and support the operationalization of the company quality standards within Vaccines IPT. The successful candidate is accountable for supporting all technical components to deliver an effective and efficient Vaccines IPT.

Responsibilities:

  • Ensure highest Quality, Compliance and Safety standards are adhered to.
  • Protocol/report authoring/execution/oversight/approval as appropriate.
  • Recommend technical approaches in line with global and local standards.
  • Ensure supply of high quality product through ensuring equipment availability; maximize team member performance through continuous process improvement initiatives.
  • Benchmark and remain current with development of new technologies in the vaccine and biopharmaceutical processing field of expertise and seek to deploy process improvements through innovation and utilization of these technological advances.
  • Participate in problem solving teams across all areas of the Vaccine IPT.
  • Support process related deviations and reports.

 

Minimum Qualifications and Experience:

  • Degree or Masters in a Science or Engineering discipline.
  • Minimum 4 years’ experience in a regulated manufacturing environment.
  • Demonstrated knowledge in validation and other pharmaceutical or Biopharmaceutical operations (e.g. manufacturing, technology, engineering, quality, analytical.)
  • Demonstrated delivery of a section of a process / technical project.
  • Understanding of temperature mapping activities, requalification requirements of equipment, periodic reviews of equipment.
  • Knowledge and understanding of the requirements around sanitization and sterilization processes.
  • Some automation (DeltaV knowledge preferable but not essential.)
  • Demonstrated process qualification and validation SME background within the pharmaceutical or Biopharmaceutical industry.
  • Demonstrated capability to deliver results RFT, in an FDA / HPRA Regulated production environment.
  • Demonstrated high level of problem solving and facilitation skills.
  • Working and collaboration across multiple functional teams.
  • Change management skills.
  • Preference for Lean Six Sigma qualification or experience of application of Lean principles.
  • Project management qualification such as, Project Management Professional 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.

 

 

11016 - Quality Specialist – Tipperary

Purpose:

The External QUALITY Specialist is responsible for ensuring that all company products managed by External Quality Assurance (EQA) are manufactured, packaged, analyzed, released, stored, and distributed in accordance with company expectations and all applicable regulatory requirements. Responsible for External Party / External Partner (EP/ExP) operations related to the quality of products produced, under the oversight and guidance of the Product Quality Manager Lead – EQA. Role has primary batch release responsibility. Incumbent will ensure that effective and robust Quality systems are in place to comply with required regulations, policies and guidelines governing the EP/ExP’s manufacture and release of (API intermediates, API) by means of risk-based quality oversight and on-site supervision, as appropriate.

Responsibilities:

  • Evaluate and/or release products to other sites and/or to the market with the assurance that the goods were produced in conformance to all applicable policies/procedures of company and compliance with all governing regulations; review and approve changes to master batch records.
  • Manage routine deviations and complaints and assist in the coordination of significant investigations including Fact Findings; assist in the coordination of any product recall involving the external manufacturer.
  • Provide guidance to the partner on conducting investigations of batch rejection, atypical events, customer complaints, etc. where warranted.
  • Provide support for audits of EP/ExP by company and regulatory agencies; review audit outcomes pertaining to external manufacturers and ensure appropriate and timely corrective actions are warranted.
  • Support routine analytical change requests and support process modification change controls.
  • Annual Product Review assembly.
  • Support document requests for regulatory filings and post approval changes.
  • Gap remediation plans, Quality Risk Management data inputs, and data integrity gap assessments.
  • Receive and share Quality Alerts and Quality Bulletins with EP/ExP.
  • Closely collaborate with appropriate business/operations and technical areas to achieve company objectives.
  • Ensure both operational knowledge and technical skills are maintained and compliant against individual training requirements.

 

Minimum Qualifications and Experience:

  • You are likely to have a BS Biology, Microbiology, Pharmacy, Chemistry, Chemical Engineering (or equivalent) preferred.
  • Minimum of 5 years’ experience in the pharmaceutical industry with a thorough knowledge of Quality Systems, Quality Assurance and Quality Control including solid knowledge of global GMP and regulatory requirements.
  • Competent in analyzing complex product, production and testing issues and have demonstrated scientific problem-solving capabilities.
  • Possess strong compliance mindset, demonstrated interpersonal skills, including leadership and coaching, motivation, communication and negotiation.

 

 

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.

 

 

10940 - Utilities Engineer – Dublin

Purpose:

Responsible for supporting the Facilities & Utilities Department in a GMP and Sterile Environment. Ensure that objectives are effectively achieved, consistent with the company’s requirements to ensure compliance, safety and reliable supply to our customers.

Responsibilities:

  • Attend meetings where required, which may include meeting facilitation.
  • Involved in the site’s Energy Policy and Energy Management System. Gathering energy data and presenting. Making recommendations on how to better energy performance.
  • Manage small projects; expectation to deliver end to end small projects with the support of colleagues.
  • Direct and/lead deviations, out of tolerance conditions and unexpected results, conducting failure analysis, root cause determination and implementing corrective actions.
  • Preparation and analysis of facilities metrics reports to trend for improved operational efficiencies. These metrics will be diverse in nature and range from Energy performance indicators to tracking quality notifications, or PMs on SAP (for example.)
  • Format, write, deliver and review necessary documentation in line with the standard approval process, and facilitate others to do so. Documents will include SOPs, SWI’s, training documents, JSAs, PMs and change controls.
  • Accountable for leading investigation analysis, identifying true root cause, identifying gaps and actions to close gaps.
  • Collaborate with IFM colleagues and non IFM colleagues, particularly IPT, Quality, EHS, Technical Engineering, in completion of tasks to ensure best practice.
  • Identify, troubleshoot, investigate and remedy equipment issues and incidents, using Lean Six Sigma tools as applicable. Lead root cause analysis investigations for equipment issues and incidents.
  • Support the creation and maintaining of the CMMS and CCMS.
  • Support Project Asset Management Strategy (PAMS) as required, e.g. strategic spare parts strategy, FMECAs, equipment criticality assessment.
  • Leadership activities including selection, development, coaching and day to day management. Ensure that the team receives 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.
  • 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.
  • May be required to perform other duties as assigned.

 

Minimum Qualifications and Experience:

  • Diploma or higher preferred, ideally in a related discipline.
  • Would typically have prior related work experience; ideally in a manufacturing, preferably GMP setting.
  • Effective communication and interpersonal skills to interface effectively with all levels of colleagues in a team environment.
  • Knowledge of regulatory/code requirements to Irish, European and International Codes, Standards and Practices.
  • Report, standards, policy writing skills required.
  • Sterile filling processes and equipment.
  • Proficiency in Microsoft Office and job related computer applications required Lean Six Sigma Methodology experience desired.
  • Effective communication and interpersonal skills to interface effectively with all levels of colleagues in a team environment, and with external customers.
  • Understand the specific responsibilities of all Carlow departments as they relate to one’s own department, understanding the business processes one’s department supports.
  • Data analysis.
  • Training skills.
  • Identifies own areas for development and works on these; seeking manager input to aid this development.

 

 

10875 – Engineering Document Manager - Dublin

Purpose:

This role will be to establish and manage the organisation’s Electronic Documentation Management System (Including Drawing Management system) in preparation for Project Documentation Turnover. As an integral part of the Engineering team you will be responsible for developing standard documentation methods and procedures for efficient management of Engineering Documentation and Drawings. The selected candidate will also be responsible for developing new drawings and amending existing drawings to reflect as built conditions in the field. Candidates should be motivated and enthusiastic, have the ability to work on their own initiative and be able to meet deadlines and liaise successfully with clients.

Responsibilities:

  • Support set-up and implementation of Electronic Documentation Management System.
  • Establish EDMS Standards and Procedures.
  • Produce and amend drawings in line with the site Drawing Management System.
  • Participate in all activities within the drawing office. Ensure that all architectural, electrical, mechanical, civil, instrumentation, general layout drawings are at the correct revision.
  • Ensure that all change management updates are captured and reflected on the appropriate documentation.
  • Ensure that documentation and drawing packages issued from projects are correct and are in line with site standards.
  • Ensure compliance for all standards and procedures that fall under the responsibility of the organisation.
  • Assist with the development of draughting and documentation staff as required.
  • Ensure all documentation and drawings are stored correctly in electronic and paper format and that all drawings issued and received by the department.
  • Carrying as built surveys of existing P&ID drawings and ensure current drawings reflect the as built site conditions.
  • Work closely with Engineering Project Teams to develop solutions.
  • Ensure all activities are carried out in line with Company QA & EHS Requirements and Procedures. Play an active role in the Documentation and CAD Standards/Standard Operating Procedures input.

 

 

Minimum Qualifications and Experience:

  • Minimum of Higher National Diploma or Higher National Certificate qualification in Engineering.
  • 7+ years Industry Experience with 2+ years working in a similar role.
  • Good knowledge of GMP / FDA regulatory requirements and current Health and Safety Regulations legislation.
  • Experience with 3D modelling software packages.
  • Interact with above site personnel to understand changes and promote the site.
  • Solid engineering acumen.
  • Demonstrated capability to communicate effectively across multiple teams.
  • Project Management experience an advantage.

 

 

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.

 

 

10882 – Associate Quality Specialist - Cork

Purpose:

This position within the QA department will provide Quality oversight, support and knowledge to activities relating to Quality oversight of GxP vendors and supply chains and in meeting the company priorities of: Compliance, Supply, Strategy and Profit Plan. The team working style is one of collaboration, coaching and facilitation to ensure the success of the site. The Associate Quality Specialist is accountable for the Quality Systems within the site. This role requires the delivery of robust Quality oversight to support a flexible, collaborative, multi-skilled teamwork environment. The Quality Specialist will have proven capability in development of Quality Systems as an active member, across cross functional teams, to deliver process improvement. The Quality Specialist will model the company Leadership behaviours and understand the MPS principles to drive a culture of continuous improvement building a High-Performance Organisation. The Quality Specialist will participate and comply with the company’s Quality Management System (QMS) requirements, including ownership.

Responsibilities:

  • Provides to the site knowledge and experience in Quality Systems especially related to Vendor Management.
  • Uses knowledge to improve Quality Systems, solve problems, provide continuous improvement and execute tasks.
  • Provides compliance contribution to project teams and leads small projects.
  • Coaches and guides colleagues within the site.
  • Understands and applies regulatory / compliance requirements to their role together with remaining current on upcoming regulatory and compliance changes.
  • Responds to non-standard requests from customer needs.
  • Makes decisions within guidelines and policies which impact own priorities and allocation of time to meet deadlines.
  • Supports Corporate Quality to ensure actions at the site are executed.
  • Participation in inspections of Site by Divisional / Regulatory Bodies / third parties together with follow up actions where applicable.
  • Participation in and leading internal inspections.
  • Supplier management oversight.
  • Ensures supply of high quality product through the implementation and oversight of the Quality System for the site.
  • Champion the highest Quality and Compliance standards for the site.
  • Ensure highest safety standards.
  • Additional activities as requested by QA Lead.

 

Minimum Qualifications and Experience:

  • Degree or 3rd level qualification (Science, Quality.)
  • 3 – 5 years’ experience in the Pharmaceutical industry or a similar operating environment which includes experience in a Quality function.
  • Demonstrated knowledge in more than one pharmaceutical and/or chemical manufacturing operation.
  • Quality Assurance SME knowledge, from both operational and educational experience, is required.
  • Knowledge and experience in interpreting current regulatory requirements and providing independent support to the site.
  • Demonstrated ability to work independently and fully realize improvement initiatives with a moderate level of guidance.
  • Demonstrated ability to work and succeed within teams as well as leading small project teams.
  • Demonstrated ability to drive the completion of tasks.
  • Proven track record of providing independent Quality support to the site.
  • Advanced PC skills such as Excel, Word, PowerPoint.
  • 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.
  • Energetic with proactive & positive attitude.
  • Demonstrated coaching skills.
  • Demonstrated ability to solve problems.
  • Desirable evidence of Continuous Professional Development.

 

 

9921497 – Admin Support - Dublin

Purpose:

The GSC Senior Administrative Assistant will support the Global Supply Chain department.

Responsibilities:

  • Supporting the VP and Head of Global Supply Chain with scheduling meetings, managing calendars, and day to day administrative responsibilities.
  • Manage T&E budgets ensuring no over-runs without prior approval.
  • Preparation of complex, ever changing international and domestic travel arrangements; including: booking flights, accommodation, car service, arranging meetings and preparation of itineraries for the Global Supply Chain leadership team.
  • Liaise with senior level executives and their staff to coordinate activities and meetings around the globe.
  • Handle extremely confidential and proprietary information with utmost discretion.
  • Act as gatekeeper, screening phone calls, responding or delegating to insure timely response.
  • Coordinate both small and large meetings, conference calls and global video conferences including advanced preparation of materials and audio/visual facilities.
  • Arrange visitors travel plans as required.
  • Process invoices and expenses ensuring all are paid on time while adhering to strict compliance guidelines, play a key role in budget tracking.
  • Open and manage Purchase Orders in SAP.
  • Responsible for filing, copying, scanning and faxing.
  • Responsible for co-ordinating & running monthly & GSC yearly team events.
  • Responsible for incoming contracts. Contracts need to be vetted and signed in a timely manner.
  • Responsible for regularly updating GSC Org charts and Distribution lists.
  • Other duties as assigned.

 

Minimum Qualifications and Experience:

  • Diploma in Business Studies or equivalent.
  • Experience supporting an Executive and multiple senior personnel.
  • Minimum 5 years of experience using MS Office Suite (MS Word, Excel, PowerPoint and Outlook.)
  • Highly proactive and willing to take initiative.
  • Ability to maintain confidentiality.
  • Strong relationship building skills – with peers and Administrative teams.
  • Mature and must remain composed while multi-tasking under pressure.
  • Ability to prioritize, identify problems and seek solutions.
  • Excellent organizational, attention to details and communication skills.
  • Ideal candidate will be adaptable to a variety of situations.
  • Ability to work independently.
  • Follows up and completely with a variety of tasks in a timely manner.
  • Enthusiastic person with a high level of professionalism.

 

 

2020-326 - Engineering Warehouse Stores Keeper - Waterford

Purpose:

Support of Waterford Operations by ensuring availability, accuracy and cost-effectiveness of Engineering Spares, Indirect Materials and Operations Consumables.

Responsibilities:

  • Maintain Engineering Spare Stocks and Accuracy to agreed levels and costs.
  • Support improvement projects including Barcoding of spares locations and reporting of ERPLx Key stores indicators.
  • Internal reporting and analysis of spare parts usage and costs.
  • Tracking and management of parts for External Repair.
  • Ensure all NSIR’s are processed and uploaded in a timely manner. Report monthly metrics on same.
  • New Item Set Up.
  • Ensure daily Stores activities complete.

 

Minimum Qualifications and Experience:

  • Excellent time keeping and attendance.
  • Minimum 2 years’ experience in Inventory Management and Engineering Stores Role(s) or Equivalent Qualification.
  • ERPLx report generation and Advanced Excel.
  • Excellent Organisation Skills.
  • Relevant experience in customer service.
  • Experience of reporting data analytics is desirable.
  • Self-starter and uses own initiative.
  • Excellent interspersonal skills.

 

 

10934 - Data Integrity / Instrument Specialist - Tipperary

Purpose:

The Analytical Development and Commercialisation (ADC) department is responsible for all analytical support to the site. This involves testing of raw materials, Excipients, Components, intermediates, Drug Substance and Drug product. We are currently recruiting for the position of Instrument/Data Integrity Specialist in support of these activities. The position reports to the Laboratory Systems Lead. The position offers the opportunity to work with a team of professionals in a modern analytical laboratory using the most up to date technology and quality assurance procedures. The laboratory operates under Lean principles and employees the use of a wide variety of analytical techniques.

Responsibilities:

  • Maintaining Analytical Laboratory instrumentation in validated state to support testing activities in accordance with site schedules and company policies, procedures and guidelines.
  • Support the introduction of new technology and instrumentation to the site with a focus on Data Integrity principles.
  • Be part of the Data Integrity team for the laboratories ensuring all DI milestones are met.
  • Be part of a dynamic team responsible for Data Integrity requirements for all computerised and non-computerised systems across all the laboratories.
  • Aid in the resolution of issues that may arise during laboratory instrument qualification and use
  • Participate in assigned improvement projects.

 

 

Minimum Qualifications and Experience:

  • Applications are invited from candidates who have a degree in Science (Chemistry, Physics or related Life Science) and/or relevant experience.
  • 5+ years’ experience.

 

 

10924 - EHS Specialist - Dublin

Purpose:

The EHS Specialist will ensure the organisation assists all regulatory and corporate requirements from an EHS & Risk Management perspective, coordinating and implementing all assigned OH&S tasks related to EHS objectives and activities on site.

Responsibilities:

  • Ensure robust systems are developed and in place for Risk Management, EHS Compliance Auditing, EHS Culture, EHS training, Incident Management, EHS communications etc. on site.
  • Manage the emergency response programme including ERT for the site ensuring a constant state of readiness.
  • Ensure site environmental compliance against all regulatory, EPA, Licencing and Legal requirements.
  • Chemical safety program, PSSR and new product introductions are compliant with regulations, corporate requirements and industry best practice.
  • Collaborate with other departments within the organisation to ensure corrective actions for incident investigation, RA’s etc are determined and implemented.
  • Report out weekly to management and department teams on KPIs in line with EHS objectives/targets (planned vs. actual performance.)
  • Auditing of EHS systems and other key safety and departmental systems/ programs or procedures on site.
  • Manage to day to day EHS queries, technical support, and machine / plant/ process or equipment safety issues if present.
  • Ensure the site develops and complies with Corporate EHS Standards.
  • Maintain a high standard of documentation in relation to all activities.
  • Other duties as assigned.

 

 

Minimum Qualifications and Experience:

  • Third level qualification or Diploma in Health and Safety essential.
  • Bachelor of Science qualification an advantage.
  • 3 – 5 years EHS Experience working in a Manufacturing facility – Biotech/ Pharma or similar.
  • In Depth Knowledge of Irish H&S and Environmental Legislation and regulations.
  • Excellent project management skills.
  • Proficient in the use of MS Office tools (MS Word, Excel, Power-point.)
  • Ability to work independently (a self-starter) or in a team environment.
  • Excellent communication and interpersonal skills.
  • Collaborative approach.
  • Strong ability to influence at all levels of the organisation.

 

 

10906 - Analytical Chemist - Tipperary

Responsibilities:

  • Support analytical activities in support of drug product manufacture to provide comprehensive and scientifically appropriate analytical test methods to address quality requirements for release of pharmaceutical materials to be used in development studies and for market.
  • Support the development and optimization of reliable, validated analytical methods to characterize the quality attributes of drug products for multiple projects supported by the site. Responsible for completion of analytical testing of drug products to be used in post-proof of concept clinical supplies. Assures that the appropriate information on the quality of raw materials is provided to support all studies.
  • Contributes to the development of appropriate methods and specifications for assuring the quality of drug products for inclusion in regulatory submissions. Provides the analytical information for regulatory filings and responses to queries from worldwide regulatory agencies.
  • Supports the transfer of analytical methods, specifications, and development knowledge for the drug product and its associated manufacturing process. Establishes relationships with key Supply and outsourcing partners that facilitate a clear understanding of analytical issues and product timelines.
  • In partnership with the Quality organization, develops and continually updates appropriate GMP procedures for the completion of analytical testing and review of data.
  • The successful candidate is required to work with teams comprised of scientists and engineers to effectively coordinate analytical method development efforts and support the progress for multiple projects.

 

 

Minimum Qualifications and Experience:

  • Degree in relevant science discipline.
  • 5+ years’ experience.
  • Outstanding problem-solving skills.
  • Ability to work in an interdisciplinary team environment.
  • Strong verbal and written communication skills.
  • Experience in analytical science, in particular, OSD analysis, method development and validation.
  • Preferred: Experience in analytical technology transfers.

 

 

9879023 - Cleaning Validation Engineer - Dublin

Purpose:

The Cleaning Validation Technical Specialist will support the cleaning verification/validation activities for the cGMP manufacture of biological bulk drug substance (BDS.) The Specialist will support cleaning verification/validation readiness and execution to support the facility commissioning, start-up and routine commercial manufacturing. The Cleaning Validation Technical Specialist will be responsible for validation and verification of the cleaning used to support the technology transfer of new or existing drug substance manufacturing processes to the facility, and will be required to work in close collaboration with Operations, Engineering, Quality Assurance, Quality Control, Regulatory and other involved departments to ensure successful facility startup and qualification. The position is accountable for timely completion of cleaning validation/verification related milestones, with particular emphasis on cleaning validation for a multi-product drug substance manufacturing facility.

Responsibilities:

  • Implement cleaning strategies for fixed and mobile parts per Cleaning Validation Master Plan and associated strategies.
  • Development and/or optimize cleaning (CIP) cycles/methods/recipes for buffer and media preparation systems, upstream (bioreactors) and downstream equipment trains, parts washers and supporting process equipment where applicable.
  • Generate and execute cleaning validation protocols, plans and reports as required. Provide input to Standard Operating Procedures (SOPs) and Work Instructions (WI) to enable suitable and representative cleaning sampling activities.
  • Work closely with colleagues within the Technical Services team, and with Quality Assurance, Quality Control, Commissioning, Manufacturing Operations, and Automation MCS to ensure CIP recipes, batch record instruction and standard work practices meet the needs of startup, technology transfer, and routine manufacturing timelines in the context of cleaning validation.
  • May author and review cleaning risk assessments, technical protocols and reports, cleaning validation documents, cleaning sample maps and supporting documentation as required.
  • Prioritize cleaning verification/validation activities in line with the project schedule to ensure product submission timeline is met, and regulatory approval attained.
  • Identify requirements for process, plant, or laboratory studies/trials to support cleaning verification/validation activities and to liaise closely with Operations/QC to oversee the design and execution of studies (as required.)
  • Partake in Tier Management meetings to ensure alignment between Operations and QC for sample co-ordination.
  • Identify and implement improvements where feasible.
  • Provide oversight in the execution of cleaning trials and studies on the manufacturing floor at commercial scale relating to media/buffer preparation, and process equipment. Temporary shift working may be required during periods of engineering batch and validation batch execution.
  • Provide on the floor support for troubleshooting cleaning verification/validation related issues and to lead/partner on cleaning/manufacturing investigations into process deviations.
  • Author/review technical documents for SOPs, master data, material specifications and/or regulatory agency submissions which related to cleaning activities.
  • Collate cleaning verification/validation data in control charts and identify any trends.
  • May serve as a subject-matter expert on specific cleaning verification/validation activities during regulatory agency inspections.
  • Ensure samples are taken when required and accounted for per plan. Ability to escalate issues or learnings in a timely manner to ensure no impact to cleaning validation workfront.

 

 

Minimum Qualifications and Experience:

  • Minimum requirement B.Sc. in Biochemistry, Biology, Chemistry or equivalent, or B.Eng. Process or Chemical Engineering.
  • Minimum 2 years’ experience in Cleaning verification/validation / Technical Services / Manufacturing / Technical Development/Quality Support in a biological bulk drug substance or drug product manufacturing organization.
  • Technical and operational knowledge of Cleaning validation/verification, quality systems and regulatory requirements across multiple health authorities (would be advantageous.)
  • Experience of cleaning verification/validation is beneficial, and/or cleaning approaches to multiproduct is advantageous.
  • Comprehensive understanding of cGMP requirements for biopharmaceutical manufacturing.
  • Good interpersonal skills coupled with demonstrated ability to effectively work in a matrix organization.
  • Ability to present and successfully defend technical and scientific approaches in both written and verbal form.
  • Ability to drive for results independently and adapt to rapidly changing priorities.

 

 

9961114 - QA Validation Specialist - Dublin

Purpose:

Responsible for delivery of quality assurance activities at the facility from start up through to commercial readiness to ensure commercial and/or clinical products are manufactured in accordance with cGMP, Corporate and Regulatory requirements. This responsibility requires the delivery of QA and compliance support for the Irish site(s.) The Quality Assurance Validation 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, 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 and ongoing product disposition.
  • Provide QA support for risk-based verification activities in the capacity of Quality Assurance Subject Matter Expert. Review and approval equipment/utilities verification documentation from design to post execution.
  • Participate in verification quality risk assessments and provide quality oversight to ensure verification quality risk assessments are effectively maintained/controlled.
  • QA support for implementation of Manufacturing Execution System (MES) computer system validation deliverables.
  • Review and approval of engineering functional area documentation (SOP, Work Instructions, Criticality Assessments, technical report and protocols.)
  • Authoring, review and approval of QA-related procedures.
  • Oversee the effective documentation and tracking of quality management system activities including deviations and change controls and CAPA.
  • Review and approve Validation protocols as required. (Examples include cleaning, process, method validation.)
  • Support the vendor quality management programme.
  • Participate in regulatory inspections as required.
  • Develop and report quality metrics.
  • Provide quality oversight of calibration and preventative maintenance criticality assessments as required.
  • Represents Quality Assurance to guide various projects and technical meetings, as needed.
  • Responsible for documenting and reporting compliance issues to management.
  • Interface with relevant departments to ensure compliance with corporate policies, GMP and regulatory requirements.
  • Any other duties as expressed by the manager.

 

 

Minimum Qualifications and Experience:

  • Sc. in science/pharmacy with a minimum of 5 years’ experience in cGMP Quality environment to include biopharmaceutical experience.
  • Min 5 years QA experience in a pharmaceutical manufacture/biopharmaceutical environment. (BDS experience is essential.)
  • Must have strong process knowledge to include upstream and/or downstream processing.
  • 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.

 

 

10856 - Lab Analyst - Tipperary

Purpose:

The ADC Laboratory Analyst is responsible for the execution and documentation appropriately of testing and analysis of Raw Materials, Intermediates, Drug Substance & Drug Product in accordance with Quality Standards and/or other approved protocols. To provide analytical support to product quality investigations including the use of sophisticated analytical techniques. To undertake significant assignments and to work on own initiative and with minimum supervision e.g. technology transfer for new product demonstrations; new methods development; management of an on-going programme such as the Intermediate Stability programme & to provide training for other Laboratory Analysts and other lab personnel.

Responsibilities:

  • The Laboratory Analyst has responsibility for Raw Material, Intermediate and Drug Substance testing to meet compliance requirements and customer targets. The Analyst may also take a leadership role in change or improvement projects in ADC or at a site level.
  • The Laboratory Analyst is responsible for ensuring all testing activities comply with cGMP. The Laboratory Analyst assures compliance with all safety and environmental requirements. Compliance with other regulated areas such as HR policies are also responsibilities of the role.
  • To test Raw Materials, Intermediates, Drug Substance, Drug products in accordance with Quality Standard and/or other approved protocols.
  • To comply with all GMP and analytical procedures relevant to area of work.
  • To adhere and comply with department High Performance Analytical Behaviours.
  • To document all testing activities and to input results into computerised lab systems in accordance with department and company standards.
  • To provide analytical support to product quality investigations and new product demonstrations under the supervision of the Laboratory Leader or designate.
  • Complete the investigation of laboratory OOSs in line with site and divisional procedures.
  • Complete documentation checks (e.g. PCR’s, ACRs, Deviations) as required for the Drug Substance/Drug Product test package prior to release.
  • To complete testing as required on samples to support process changes.
  • Accountable for own laboratory safety practices.
  • To provide lead analytical support to product quality investigations and new product demonstrations using own initiative and with minimum supervision.
  • Provide leadership in the laboratory aspects of OOS investigations.
  • To identify and aid resolution of analytical issues within the IPT laboratory.
  • To be a resource for analytical testing for the site as required.
  • Execute specific assignments (e.g. stability programme, instrument management and other systems) in a comprehensive manner and under minimum supervision.

 

 

Minimum Qualifications and Experience:

  • Graduate of a science-based discipline.
  • Minimum of BSc in Chemistry or related discipline.
  • 3-5 years’ experience in a similar position.
  • Empower experience is an advantage; HPLC/GC and Ion Chromotography experience in addition to wet chemistry techniques.
  • Have knowledge of GMP standards.
  • Have knowledge Laboratory safety standards.
  • Must have good communication skills, both written and verbal.
  • Strong documentation skills are required.
  • Must be motivated, focused and technically strong.
  • To perform analytical testing with a high degree of precision and accuracy.
  • To perform instrument maintenance and troubleshooting.
  • To maintain accurate records in compliance with GMP expectations.
  • To understand and internalise procedures relevant to GMP operations.
  • To communicate clearly and concisely on technical issues.
  • On assignment, to deliver project goals on time.
  • Analytical chemistry – demonstrated ability in all technical elements relevant to site ADC IPT operation.
  • Technical lab skills (precision, etc.)
  • Strong aptitude for handling analytical instruments.
  • Mechanical and computer.
  • Communication – written, oral.
  • Team and interpersonal skills.
  • Leadership skills.

 

 

10853 - Project Coordinator - Cork

Purpose:

The Project Co-Ordinator will provide project scheduling and co-ordination expertise to the site which manufactures quality pharmaceutical products in accordance with the company Manufacturing Division priorities of: Compliance, Supply, Strategy and Profit Plan. This individual will be a part of the Project Management Office (PMO), its goal being to ensure the site delivers on its key strategic projects and initiatives. These projects fall into but are not limited to the following categories: Engineering, Supply Chain, Continuous improvement initiatives, Business transformation, Technical Programs, Other projects as dictated by company initiatives. The leadership style is one of collaboration, coaching and facilitating the project team in a high-performance organisation. This will require a substantial amount of time within the project process, engaging and communicating with all project members.

Responsibilities:

  • Facilitates schedule development sessions with project team and collects data for schedule logic, activity durations and resource requirements.
  • Manages the preparation of schedules for all phases of a project.
  • To work with the team to manage a reliable and responsive planning service for projects.
  • Responsible for ensuring that schedule updates from the various area owners are carried out, and that these inputs are cross checked and consistent with one another to support the overall Project/Program.
  • Ensures that all quality checks are carried out on the Schedule before issue.
  • To analyse project requirements and manage the preparation of a Project Master Schedule which integrates strategies and constraints for all project phases.
  • To monitor progress against schedules, analyse deviations and recommend remedial actions.
  • To co-ordinate, in conjunction with colleagues, a progress measurement system and to operate the performance measurement systems.
  • Establishes working relationships across the Site /Project Teams. Negotiates and monitors levels of service or performance provided, communicates and actions areas of concern to resolve issues.
  • 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.
  • Support the development and running of the Project Management Office on site.
  • Performs additional assignments per the PMO Lead’s direction.

 

 

Minimum Qualifications and Experience:

  • Engineering Degree with 3+ years Scheduling and Planning experience preferably in the Biotechnology and Pharmaceutical sectors.
  • A minimum of five to eight years of relevant experience in project co-ordination and scheduling of a broad spectrum of projects in the Pharma industry.
  • Demonstrated leadership skills with a continuous improvement focus.
  • In depth experience of MS Project Progress Reporting, Critical Path Analysis and Key resource profiling.
  • In depth experience of Excel.
  • Project management qualification such as Project Management Professional etc.
  • Superior organizational and planning skills.
  • Demonstrated ability in holding project team members responsible for results.
  • Demonstrated ability to realise 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.
  • 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.
  • 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.
  • 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.
  • Excellent presentation skills.

 

 

10852 - 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 Manufacturing Division priorities of: Compliance, Supply, Strategy and Profit Plan. This individual will be a part of the Project Management Office (PMO), its goal being to ensure the site delivers on its key strategic projects and initiatives. The programs may be supporting some of the following areas on site: Quality and Compliance, Supply Chain & AIT, Manufacturing & Technical Transfers, Business Transformation & Site Continuous Improvement, Other Support Functions. The working style of the PMO team is one of collaboration, coaching and facilitation in providing program management support in a High-Performing Organization. This role will require a substantial amount of time within the program/project management process, engaging and communicating with Project Leads and ensuring projects within each program are delivering accordingly. 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 Quality Management System.
  • For supporting the development and running of the PMO on site.

 

Minimum Qualifications and Experience:

  • Appropriate 3rd level qualification.
  • 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.
  • Appropriate program/project management qualifications.
  • 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.

 

 

2020-325 - QC & Commercial Stability Data Reviewer - Waterford City

Purpose:

To support Product Development and Commercial Supply by ensuring all components, raw materials, finished products and Stability are tested in accordance with cGxP.

Responsibilities:

  • To review raw data from testing of components/raw materials/finished products and stability in a timely & efficient manner.
  • To manage and control all raw data presented for review and file once completed.
  • To complete required release documentation including commercial stability summary sheets.
  • Trending of finished product and API testing.
  • Complete investigations in a timely and efficient manner where applicable.
  • Identify and action recommendations for improvements.
  • Implement 5S and Lean lab initiatives.
  • To support all other on-going laboratory functions & requirements.
  • 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.
  • To perform additional team tasks as agreed to support effective running of the Business.
  • To assist in the preparation for customer/ regulatory inspections.
  • Health & Safety;
    • Implement safety requirements as per site documentation including SOPs, Safety Statement and COPs.
    • Report any defects.
    • If unsure about safety requirements – ask.

 

Minimum Qualifications and Experience:

  • Qualified to a minimum of degree level.
  • At least two years’ experience working in a related technical environment.
  • Analytical Test Methods – Creation and Review.
  • Operation of HPLC.
  • Operation of GC, FT/IR.
  • Computer Skills/Excel etc.

 

 

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.

 

 

10861 - Chemical Engineer - Tipperary

Responsibilities:

  • API IPT Technical team member with responsibility for co-ordination of change control for API processes, particularly supply chain related changes.
  • Support for Regulatory Tier requirements for API IPT business.
  • Support for Regulatory declarations.
  • Identifying continuous improvement activities and leading or participating in cross-functional teams to implement.
  • Other API IPT Technical team requirements as per business needs.
  • Responsible for progressing API IPT related changes through the change management process in order to meet production demands.
  • To maintain accurate records in compliance with GMP expectations.
  • To understand and internalise procedures relevant to GMP operations.

 

Minimum Qualifications and Experience:

  • Degree qualification in a science or engineering-related discipline. Will consider new (strong) graduates.
  • Previous experience in API or Drug Product manufacturing is desirable.
  • Knowledge of GMP standards.
  • Good communication skills, both written and verbal.
  • Strong technical writing skills.
  • Communicate clearly and concisely on technical issues.
  • Deliver project goals on time.
  • Demonstrated ability to work as part of a diverse team in an inclusive manner.
  • High personal integrity, credibility and energy.
  • Must be motivated and focused, with a demonstrated ability to be self-driven.

 

 

10846 - Associate Quality Specialist - Quality Systems - Cork

Purpose:

This position within the QA department will provide Quality oversight, support and knowledge to activities relating to Quality Systems across the site and in meeting the company priorities of: Compliance, Supply, Strategy and Profit Plan. The Associate Quality Specialist is accountable for the Quality Systems within the site. This role requires the delivery of a robust Quality Management System to support a flexible, collaborative, multi-skilled teamwork environment. The Quality Specialist will participate and comply with the company Quality Management System (QMS) requirements, including ownership.

Responsibilities:

  • Provides to the site knowledge and experience in Quality Systems.
  • Uses knowledge to improve Quality Systems, solve problems, provide continuous improvement and execute tasks.
  • Provides compliance contribution to project teams and leads small projects.
  • Coaches and guides colleagues within the site.
  • Understands and applies regulatory / compliance requirements to their role together with remaining current on upcoming regulatory and compliance changes.
  • Responds to non-standard requests from customer needs.
  • Makes decisions within guidelines and policies which impact own priorities and allocation of time to meet deadlines.
  • Supports Corporate Quality to ensure actions related to Quality Systems at the site are executed.
  • Participation in inspections of Site by Divisional / Regulatory Bodies / third parties together with follow up actions where applicable.
  • Participation in and leading internal inspections.
  • Supplier management oversight.
  • Ensures supply of high-quality product through the implementation and oversight of the Quality Management System for the site.
  • Champion the highest Quality and Compliance standards for the site.
  • Ensure highest safety standards.
  • Additional activities as requested by QA Lead.

 

Minimum Qualifications and Experience:

  • Degree or 3rd level qualification (Science, Quality.)
  • 3 – 5 years’ experience in the Pharmaceutical industry or a similar operating environment which includes experience in a Quality function.
  • Demonstrated knowledge in more than one pharmaceutical and/or chemical manufacturing operation.
  • Quality Assurance SME knowledge, from both operational and educational experience, is required.
  • Knowledge and experience in interpreting current regulatory requirements and providing independent support to the site.
  • Demonstrated ability to work independently and fully realize improvement initiatives with a moderate level of guidance.
  • Demonstrated ability to work and succeed within teams as well as leading small project teams.
  • Demonstrated ability to drive the completion of tasks.
  • Proven track record of providing independent Quality support to the site.
  • Advanced PC skills such as Excel, Word, PowerPoint.
  • 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.
  • Energetic with proactive & positive attitude.
  • Demonstrated coaching skills.
  • Demonstrated ability to solve problems.
  • Desirable evidence of Continuous Professional Development.

 

 

9958425 - Warehouse Associate - Dublin

Purpose:

The Warehouse Operator is responsible for the day to day warehouse activities at the Dublin facility. They are responsible for ensuring that all warehouse activities are completed as per approved Standard Operating Procedures (SOP’s), in a safe manner and in compliance with current Good Manufacturing Practices (cGMP.) The individual in this position is expected to represent company interests, objectives and policies in a professional and responsible manner.

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 warehouse activities to meet schedules while maintaining a high level of GMP compliance.
  • Maintaining the Warehouse Quality System by adherence to all relevant SOP’s, policies and cGMP requirements.
  • To aid with troubleshooting and resolving operational problems.
  • Act as a subject matter expert for the Warehouse group in relevant equipment and system root cause investigations and fill the role of lead investigator where required.
  • Support continuous improvement initiatives by identifying areas needing improvement, recommending strategies for improvement, and implementing those strategies once approved.
  • Carry out dispensing activities in a controlled environment.
  • Report to Warehouse Supervisor on a regular basis on area performance and report any issues that need to be resolved.
  • Proactively ensuring that all Environmental, Health and Safety responsibilities are carried out according to EHS regulations and procedures.
  • Maintaining spare parts, change parts etc. in the Engineering Stores.
  • Utilising and maintaining IT systems as required, e.g. SAP.
  • Provide support to Operations, Validation, Engineering and Quality where required.
  • Complete training with new/junior Warehouse Operators.
  • Other duties as required.

 

Minimum Qualifications and Experience:

  • Current or previous formal education in logistics/warehousing/supply chain would be an advantage.
  • 2-5 years’ experience performing Warehouse support activities preferably in a cGMP commercial manufacturing environment.
  • Previous experience with dispensing activities preferred.
  • Must be able to work within and adapt to complex electronic systems such as SAP.
  • Good interpersonal, communication and problem-solving skills.
  • Should be knowledgeable of regulatory and GMP requirements.

 

 

10755 - Validation Engineer - Cork

Purpose:

The Validation Engineer/ Technical Specialist will be required to collaborate and facilitate running of activities (PPQ batch manufacture, validation activities, 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:

  • Technical/Validation activities but relating to all activities to enable the team’s performance in the Vaccine Technical group within the Vaccine IPT.
  • Project validation support including conducting equipment performance qualifications (cleaning and sterilization validation periodic reviews, re-qualifications, temperature mapping.)
  • Authoring project validation master plans, SOP and documentation updates, authoring validation protocols and final reports, executing validation studies, analysis of validation data.
  • Resolving technical issues encountered during study execution. Lead and close process 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/DN/MDNs etc.)
  • This individual will be required to work in a cross-functional team and independently to accomplish validation project objectives.
  • Experience with audits and preparation for audits.
  • Works with moderate work direction and is skilled and knowledgeable to the position.
  • Responsible for the technical support of manufacture in the Vaccine IPT.
  • Technical review, ownership of and approval of Global Change Management records as required.
  • Recommend technical approaches in line with global and local standards.
  • Contribute for driving a culture of Continuous Improvement by deploying Our 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 Manufacturing Division Quality Management System (QMS) requirements, including ownership, as relevant.

 

 

Minimum Qualifications and Experience:

  • Degree or Masters in a Science or Engineering discipline (preferably Biotechnology.)
  • 5+ years’ experience.
  • 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.

 

 

10815 - Associate Quality Specialist - Cork

Purpose:

This Associate Quality Specialist will provide quality oversight, support and knowledge to activities relating to Quality Systems across the site and in meeting the company Priorities of: Compliance, Supply, Strategy and Profit Plan. This role requires the delivery of a robust Quality Management System to support a flexible, collaborative, multi-skilled teamwork environment. The team working style is one of collaboration, coaching and facilitation to ensure the success of the site. The Associate Quality Specialist is accountable for the Quality Systems within the site.

Responsibilities:

  • Provides to the site, knowledge and experience in Quality Systems and/or Operational Quality, e.g. Batch record Review, Deviation/NOE/LIR coaching; GCM coaching, environmental monitoring program, sterile assurance, customer complaint investigations etc.
  • Uses knowledge to improve Quality Systems, provide continuous improvement and execute tasks.
  • Understands and applies regulatory / compliance requirements to their role.
  • Responds to standard requests from customer needs.
  • Makes decisions within guidelines and policies which impact own priorities and allocation of time to meet deadlines.
  • Participation in inspections of Site by Divisional / Regulatory Bodies / third parties.
  • Ensure supply of high quality product through the implementation and oversight of the Quality Management System for the site.
  • Ensure the highest Quality, Compliance and Safety standards.
  • The Quality Specialist will participate and comply with the company Quality Management System (QMS) requirements, including ownership.

 

 

Minimum Qualifications and Experience:

  • Degree or 3rd level qualification (Science, Quality.)
  • 1 -3 years’ experience in the Pharmaceutical industry or a similar operating environment which includes experience in a Quality function.
  • Demonstrated knowledge in one or more pharmaceutical and/or chemical manufacturing operation (i.e. quality, science etc.)
  • Operational experience of at least 4 QMSs.
  • Quality Assurance knowledge, from both operational and educational experience, is required.
  • Demonstrated use of Leadership Behaviours.
  • Knowledge and experience in interpreting current regulatory requirements and providing support to the site.
  • Demonstrated ability to work independently and fully realize improvement initiatives with a moderate level of guidance.
  • Demonstrated ability to work and succeed within teams.
  • Demonstrated ability to drive the completion of tasks.
  • Advanced PC skills such as Excel, Word, PowerPoint.
  • Demonstrated ability to maintain and strengthen trust relationships with people on all levels.
  • Proven decision making capability with accountability and responsibility.
  • Demonstrated ability to solve problems.
  • Lean Six Sigma Yellow Belt or suitable alternative.

 

 

10810 - Training Specialist - Cork

Purpose:

The Learning Specialist will define, develop, and facilitate all learning and development plans and activities within the site in support of the site’s learning and development strategy and Annual Learning Plan. This individual will business areas to implement and ensure adherence to the site’s learning processes/system and will work with their peers to continuously improve the learning processes through to foster a continuous learning environment.

Responsibilities:

  • Establishes relationships with site cross functional areas (IPT, Support Functions, GSFs and CoEs) to understand the business objectives and collaboratively defines learning and develop strategies that enable run the business activities as well as future growth.
  • Conducts learning needs assessments and/or job analyses with client to identify relevant learning plans and solutions.
  • With the business areas, implements learning and development plans inclusive of job and functional skills. Monitors progress with appropriate documentation and metrics and defines opportunities for continuous improvement.
  • Strong Project Management focus and ability to work closely with Project Teams in training determination and co-ordination.
  • Qualifies and coaches’ trainers and classroom facilitators within client group to ensure optimal delivery of training programs.
  • Ensures implementation of global, site and local area training programs, as needed. Delivers assigned routine training as required.
  • Works collaboratively within the Learning organization to implement, maintain and continuously improve site learning processes utilizing MPS and innovative technologies. (i.e. Job Skills Qualification, SOP Process, Annual GMP, Safety Programs and New Employee Onboarding.)
  • Enables Permanent Inspection Readiness and cGMP Compliance as it relates to Training/Learning & Development for the Site.
  • Support any Environmental, Health and Safety (EHS) or Quality Compliance regulatory audits as required.
  • Collaborate with Global Learning and Development, Learning Support Services and other manufacturing sites to implement best practices.

 

 

Minimum Qualifications and Experience:

  • Bachelor’s Degree or equivalent.
  • At least 3 – 5 years working in a Learning & Development role within a regulated industry such as Pharmaceutical or Medical Devices.
  • Knowledge of and experience in applying Lean Six Sigma and Lean methodologies.
  • Demonstrated coaching/facilitation skills.
  • Experience using a Learning Management System (LMS.)
  • Working knowledge and application of Learning Principles and Evaluation Methodologies.
  • Working knowledge of the regulations pertaining to training in a regulated industry.
  • Familiar with new learning methodologies.
  • Desirable: Evidence of Continuous Personal Development.
  • Desirable: Six Sigma Yellow/Green Belt.

 

 

 

10785 - QA QP's Specialist - Dublin

Responsibilities:

  • Support quality aspects of qualification and validation of drug substance production equipment, facilities, and utilities associated with Manufacturing to ensure compliance with company policies, procedures and regulatory expectations.
  • Will serve as the Quality SME for all validation activities across the site including but not limited to: Upstream, Downstream and site systems.
  • Support Validation of cleaning (CIP) and Steam in Place (SIP) cycles/methods/recipes & Cleaning Validation.
  • Input to site operations Standard Operating Procedures (SOPs) and Work Instructions (WI.)
  • Serve as a quality resource for assessing validation requirements, non-conformance, impact assessments, root cause analysis and implementation of CAPA found during CQV activities.
  • Work closely with stakeholders and SME’s from site operations, quality operations, engineering & MS&T to provide quality oversight throughout the qualification and validation lifecycle.
  • Support sustaining activities such as Exceptions and Change Management.
  • Use of Quality Risk Management and Operational Excellence to promote continuous improvement.

 

 

Minimum Qualifications and Experience:

  • Bachelor’s degree (or higher) in Engineering, Chemistry, Biology, or relevant discipline.
  • This role requires a minimum of 3 years’ experience in, Quality Assurance,Technical Operations or Engineering within the Biopharma / Pharmceutical industry.
  • Must have at least 3 years of experience in commissioning, qualification, and validation activities in in a regulated environment.
  • A self-starter and results-focussed,
  • Strong contemporary knowledge of relevant cGMPs, regulations and current industry trends.
  • Experience working in regulated environment with exposure in the Regulations & guidance’s – GMP, CGMP, GAMP, 21 CFR Part 11.
  • Technical knowledge of Cleaning validation/verification, quality systems and regulatory requirements.
  • Experience in review and approval of Cleaning Validation studies.
  • Strong contemporary knowledge of relevant cGMPs, regulations and current industry trends.
  • Experience with new product introductions and/or process qualification/technology transfer.
  • Detail oriented and meticulous worker.
  • The successful candidate will also ideally have a proven track record in delivering excellence.
  • The candidate will also show ambition and drive to develop and advance their career within the company.

 

 

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.

 

 

2020-321 - Maintenance Technician - Waterford City

Purpose:

As a technician you will provide leadership and support to operations teams to ensure appropriate standards are met. The role will involve the development and implementation of improvement initiatives in all manufacturing and development operations. Please note this is a shift role 24/7 (2 days/ 2 nights / 4 off.)

Responsibilities:

  • To carry out repair and Maintenance tasks of all Process and / or Facilities Equipment, to achieve an acceptable level of production output in full compliance with Quality and Safety and cGMP Standards.
  • Input of data into Maintenance PM System including the operation of such systems.
  • Working with one’s own initiative and assuming responsibility whenever the need arises.
  • May be required to train others on all equipment, Maintenance tasks, set up procedures and safety awareness.
  • To operate and maintain all equipment, to achieve an acceptable level of production output.
  • Complete all duties as per relevant Sop’s.
  • Adhere to all relevant dress requirements with respect to cGMP’s and PPE rules.
  • Conduct all maintenance duties in a safe manner and report all safety issues or concerns.
  • Maintain the required standard of housekeeping in both the maintenance workshop/facilities area.
  • Ensure all required documentation is completed accurately and on time.
  • Ensure good time keeping and attendance at place of work.
  • Support team in achieving team goals and targets.
  • Attend Team meetings as required.
  • Actively contribute to continuous improvements across the plant.
  • Support and back up of all maintenance teams i.e. facilities and manufacturing when required.
  • Ensure correct and accurate communication of equipment issues/PMs/repairs including reporting of serious downtime (via email.)

 

 

Minimum Qualifications and Experience:

  • Junior & Senior Trade’s Certificate or an equivalent third level qualification.
  • At least 5 years’ Experience working as a Maintenance Technician in a Multi-skilled Team environment.
  • 2 years’ experience working as a Maintenance Technician in a pharmaceutical-manufacturing environment.

 

 

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.

 

 

10356 - Maintenance Engineer - Tipperary

Purpose:

The Maintenance Engineer will update SAP PM routines and schedules associated with equipment maintenance/reliability program that supports the API business. The Maintenance Engineer will have strong technical knowledge of equipment design and maintenance within the API business, a knowledge of SAP PM Maintenance system and the development / update of PMs and routines associated.

Responsibilities:

  • Work with Site Maintenance Managers, Planners, and API Maintenance & Reliability Lead on updates to the SAP PM system.
  • Support the Reliability Engineer in the execution of Reliability Centered Maintenance initiatives.
  • Liaise with equipment vendors to establish appropriate preventive/predictive maintenance schedules and assist M&I planning with job plan updating.
  • Review job plans for all equipment for maintenance execution optimization and ensure site compliance with GMP, Safety and Environmental requirements.
  • Lead IPT and site wide maintenance projects and programs e.g PME/PMO & MRO cost reduction programs.
  • Support capital and expense projects where required from a maintenance perspective.
  • Ensure OOTs & PSV FTLs are effectively root caused and closed out and support the development of the equipment annual review.

 

 

Minimum Qualifications and Experience:

  • A 3rd level qualification in Mechanical, Electrical or related discipline or demonstrated equivalent maintenance experience.
  • Minimum 5 years’ experience in a maintenance environment, preferably in a Manufacturing GMP environment.
  • Good understanding of World Class Maintenance practices and expectations.
  • Knowledge of maintenance systems and work practices for both electrical and mechanical crafts.
  • Knowledge and experience of SAP CMMS systems is essential.
  • Good understanding of equipment reliability techniques such as RCM, FMECA & Root Cause Failure Analysis.
  • Knowledge of Irish, European and International Codes, Standards and Practices.
  • Knowledge and understanding of Lean Six Sigma DMAIC methodology.

 

 

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.

 

 

2020-314 - MPS Planner - Waterford City

Purpose:

Reporting to the Supply Chain Manager, as the Master Production Scheduler, you will play an integral role in the growing pre-filled syringe and auto-injector platform. You will be the link between Global demand, Global supply, NPI and MABs operations to ensure that there is a realistic MPS for the AI and PFS operational areas. You will manage the long-term planning of production activities as part of the IBP planning process. You will need to work closely with the Operations, Product and Supply Chain NPI team to ensure that all elements are incorporated.

Responsibilities:

  • Responsible for creating realistic medium and long-term plans for operations.
  • Ensure alignment between Demand, Supply, Product, Project and NPI to create realistic plans.
  • Developing the monthly IBP Pack – creating capacity slides, plans, identifying vulnerabilities & opportunities.
  • Supporting along with other MPS planners.
  • Annual budgeting process and forecasting.
  • Inventory projections & warehouse RCCP.
  • Drive best practice planning and supply chain processes, Class A and IBP process.
  • Continuous improvement with the Supply Chain team & across the Value stream.
  • Strive to achieve the best possible metrics for +QDCI.
  • Represent Supply Chain Manager at various forums as required.
  • Ensure that key forums are supported, and reporting requirements delivered.
  • Site Supply Review, area specific supply reviews.
  • Global iObeya forums.
  • Global Fill Calls.
  • Global Supply Review.

 

 

Minimum Qualifications and Experience:

  • Degree Qualified or APICs or equivalent with 3 years + relevant post qualification experience.
  • Have a deep understanding of supply chain planning processes.
  • Ability to influence at senior level and show a positive attitude towards problem solving.
  • Ability work with a team to achieve superior results.
  • Person must have a Continuous Improvement focus and be able to demonstrate leadership in this area.
  • Be flexible and able to work to meet changing business requirements.
  • Ability to understand complex supply chain and develop solutions to support business needs.
  • Knowledge of supply chain systems e.g. SAP Athena and M2/Kinaxis systems.
  • Excellent interpersonal and communication skills.

 

 

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.

 

 

10642 - Project Manager Non-IT - Carlow

Purpose:

Reporting to the project manager, as part of a multi-discipline team, specifically responsible for the delivery to CQ of the black utility scope for a multi-product aseptic filling facility. 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:

  • Define and agree, with other Suite team leads and the Project Manager, the physical and procedural scope and scope boundaries.
  • Develop, within the overall project schedule, a schedule for the delivery of all aspects of the black utilities for the project.
  • Issue a project charter for the Suite project execution within the overall capital project.
  • Administer and report on the Black Utilities Suite Budget within the overall project budget structures.
  • Lead and manage scope, budget, schedule, safety, quality and personnel of the suite team.
  • 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.
  • Assure 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 utilities systems.
  • Provide appropriate expertise during C&Q activities as needed.
  • Participates to the supplier’s selection.
  • Helps define the C&Q strategy.
  • Coordinates 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.
  • Co-ordinate and facilitate, with the contract engineering firm, the GMP design reviews.
  • Review and Input into deliverables such as technical requirement specifications and vendor turnover documentation.
  • 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.
  • 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.
  • 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 clean utilities to Commissioning Qualification.

 

 

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 Clean 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.
  • The candidate will be a convincing communicator with strong interpersonal skills
  • Experience of design and or construction/handover of Black Utilities 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 process control systems and automation. DeltaV, BMS experience beneficial.
  • Working knowledge of C&Q documentation required for cGMP process equipment.
  • 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.

 

 

 

10451 - Validation Engineer - Cork

Purpose:

This position will provide expert technical support to the Vaccines IPT for the Qualification, Validation and Technical activities for Vaccines IPT manufacture. The Validation/Technical Specialist will be required to lead and collaborate across functional teams on site on the qualification/requalification utilities and equipment; manage external vendors for the provision of qualification services and support the operationalization of the company quality standards within Vaccines IPT. The successful candidate is accountable for supporting all technical components to deliver an effective and efficient Vaccines IPT.

Responsibilities:

  • Ensure highest Quality, Compliance and Safety standards are adhered to.
  • Protocol/report authoring/execution/oversight/approval as appropriate
  • Recommend technical approaches in line with global and local standards.
  • Ensure supply of high-quality product through ensuring equipment availability; maximize team member performance through continuous process improvement initiatives.
  • Benchmark and remain current with development of new technologies in the vaccine and biopharmaceutical processing field of expertise and seek to deploy process improvements through innovation and utilization of these technological advances.
  • Participate in problem solving teams across all areas of the Vaccine IPT
  • Support process related deviations and reports.

 

 

Minimum Qualifications and Experience:

  • Degree or Masters in a Science or Engineering discipline.
  • Preference for Lean Six Sigma qualification or experience of application of Lean principles.
  • Project management qualification such as, Project Management Professional is desirable.
  • Minimum 6 years’ experience in a regulated manufacturing environment.
  • Demonstrated knowledge in validation and other pharmaceutical or Biopharmaceutical operations (e.g. manufacturing, technology, engineering, quality, analytical.)
  • Previous experience of delivering technical/validation projects.
  • Understanding of temperature mapping activities, requalification requirements of equipment, periodic reviews of equipment, autoclave and SIP requirements.
  • Knowledge and understanding of the requirements around sanitization and sterilization processes.
  • Understanding of Computer Systems Validation (DeltaV knowledge preferable but not essential.)
  • Good working knowledge of Data Integrity Requirements.
  • Demonstrated process qualification and validation SME background within the pharmaceutical or Biopharmaceutical industry.
  • Demonstrated capability to deliver results RFT, in an FDA / HPRA Regulated production environment.
  • Demonstrated high level of problem solving and facilitation skills.
  • Working and collaboration across multiple functional teams.
  • Change management skills.

 

 

 

10637 - Health and Safety Specialist - Cork

Purpose:

This role is part of the Technical Operations team who support the site with bringing new equipment/ chemicals/ methods/products on site. The Technical Operations team also run a fully functional small-scale process laboratory. The successful candidate will need to solve problems and to anticipate and minimise workplace safety and environmental risks. We are interested in a candidate who can effectively prioritise, ensure regulatory and EHS standards compliance, drive continuous performance improvement efforts and maintain audit readiness within the Technical Operations Department.

Responsibilities:

  • Analyzes and inspects work environments and procedures to ensure adherence to regulations on safety, health, and the environment.
  • Designs programs to prevent disease or injury to workers and damage to the environment.
  • Collaborates with management to institute controls and remedial measures for hazardous and potentially hazardous conditions or equipment.
  • Conducts safety training and education programs and demonstrates the use of safety equipment.
  • Coordinates “right-to-know” programs regarding hazardous chemicals and other substances.

 

 

Minimum Qualifications and Experience:

  • Bachelor’s Degree required in Engineering or Science; Safety or Environmental related technical discipline is an advantage.
  • Preferred proficiency in the areas of environmental compliance and critical thinking, project management, problem solving.
  • Provides weekly compliance metric updates within the Technical Operations department.
  • Provides support for management of change, incident investigation, EHS standards compliance, auditing and capital project work as assigned within the Technical Operations department.
  • Leads and supports EHS standards compliance and audit readiness within Technical Operations department.
  • Assures completion of regulatory submissions and notifications required to maintain compliance with national EHS requirements.
  • Demonstrates collaboration with site colleagues to ensure a safe by choice culture Drives EHS improvements with clear outcomes.

 

 

 

10639 - Electrical Engineer - Tipperary

Purpose:

A vacancy exists within the Engineering Department for an Electrical Engineer supporting site Capital & Expense projects. Reporting to the Site Projects Lead.

Responsibilities:

  • Review and approve new projects electrical design and specifications. Ensure install is carried out to the specified requirements.
  • Execute strategic projects for the site.
  • Track and report progress as required against project deliverables.
  • Ensure there is a strong safety culture and performance in the execution of the capital/expense projects.

 

 

Minimum Qualifications and Experience:

  • Must have as a minimum a 3rd level qualification (Level 8) in Electrical Engineering.
  • A minimum of 5 years of relevant experience working in Pharm/Bio Pharm industry in electrical systems, engineering and project management practices.
  • Good knowledge of working in ATEX environment.
  • Experience in the design of the main Building Services Electrical systems such as MV/LV distribution and protection, Lighting systems, Small Power, Lighting, Generators, UPS and Fire safety and Detection systems.
  • 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 project management.
  • Excellent communication /presentation skills.
  • Superior organizational and planning skills.
  • Strong negotiation skills.

 

 

 

9962016 - QA Specialist - Dublin

Purpose:

The QA Specialist for External Quality will be responsible, with management support, for providing oversight of quality activities associated with the technology transfer of drug substance and drug product manufacturing processes to contract manufacturing organizations. The QA Specialist contributes and supports the completion of milestones associated with specific projects and supports ongoing quality assurance responsibilities in support of: Contract Manufacturing oversight and quality systems including Validation protocols, reports, Change Control, Deviations and CAPA’s. Performs’ all responsibilities in accordance with company policies, procedures, and regulations.

Responsibilities:

  • Serve as Quality Assurance support and SME for the technology transfer of Drug Substance and Drug Product manufacturing maintaining knowledge of industry standards and regulatory requirements to ensure all drug manufacturing, storage and shipping activities are compliant.
  • Providing oversight of GMP systems completed by CMO’s and External Supply Chain function related to Drug Substance, Drug Product.
  • Provides oversight to continuous quality system improvements and supports implementing improvements at CMO’s in compliance, Preventive Maintenance, Deviation Management and Change Control Programs as they impact the company.
  • Works closely to build relationships with contract manufacturers quality personnel.
  • Works closely with internal cross-functional impacted areas, such as External Plant Operations, CMO Management, CMC/Regulatory Affairs and Technical Services to resolve open issues in a timely manner resulting from record reviews and deviation events.
  • Responsible for reviewing contractor documents i.e. Validation protocols, validation reports, Batch records, deviations and change controls to ensure that they comply with company procedures and meet company standards.
  • Approve company specific standard operating procedures and controlled documents issued by contract manufacturing organisations.
  • Support contract manufacturing organisation audits, including pre-approval inspections.
  • Develop and issue quality metrics pertaining to the process quality activities.
  • Trends and analyses quality aspects of technical transfer activities to measure key performance indicators, identifies areas for continuous process improvements and risk mitigation, compiles and presents analyses at Quarterly Management Review meetings, proposes and leads team implementation of appropriate CAPA.
  • Reviews and assesses deviations; includes performing risk assessments, participating in root cause analysis investigations, tracking, follow-up and reporting/trending.
  • Review Corrective and Preventive Actions (CAPA); includes tracking, follow-up, and reporting/trending and evaluating CAPA for effectiveness.
  • Supports Quality Assurance to guide various projects and technical meetings, as needed.
  • Responsible for documenting and reporting compliance issues to management.
  • Any other duties as required by management.

 

 

Minimum Qualifications and Experience:

  • Bachelor’s degree required; preference given to candidates with advanced degrees; 2 or more years cGMP experience preferred including QA validation experience; consideration will be given to other relevant experience and education.
  • Minimum 2 years’ experience of drug substance/drug product manufacturing processes in a cGMP environment.
  • QA validation experience required.
  • Must have knowledge of industry best practice and current regulatory expectations concerning drug substance, drug product and finished product manufacturing.
  • Minimum of 2 years’ GMP related experience in biopharmaceutical / pharmaceutical or related industry.
  • Experience working with contract manufacturing organisations.
  • Ability to provide project leadership and guide successful completion of Quality projects.
  • Excellent written and verbal communication and negotiating skills.
  • Risk assessment and risk management.
  • Ability to exercise judgment with defined procedures and practices to determine appropriate action.
  • Ability to prioritize daily activities in order to meet internal and external customer needs on time of established timelines in a fast-paced environment.
  • Ability to monitor and report on assigned tasks, goals, and objectives.
  • Ability to operate efficiently in a complex matrix organization and international environment.
  • Strong mature leadership and interpersonal influencing skills.
  • Efficient in SAP, Firstdoc and Trackwise.
  • Note: This role requires 20% travel.

 

 

 

9864411 - Lab Systems Associate - Dublin

Purpose:

The Laboratory Systems Associate is responsible for providing support for laboratory systems, focused on validated systems. This includes system lifecycle management from onboarding through decommissioning, inventory. The Laboratory Systems Associate leads end user support efforts for all laboratory systems, including instrumentation and cross-departmental applications and provides expertise and guidance on new equipment purchases.

Responsibilities:

  • Provides end-user application support for laboratory systems including ELN, LIMS, curve-fitting, analytics and instrumentation specific software.
  • Development and ownership of the upkeep and maintenance of the CMDB (Configuration Management Database) for laboratory technology assets (over 300 computers and additional physical computer technology), lab IT software, desktop software, instrument software.
  • Provide coverage outside of Dublin to the Global Quality Labs in the US as required.
  • Provide coverage to Transgenic Labs in US as required.
  • Provide input and assist as needed with GxP laboratory solutions from IT business partners and assist with implementation of Laboratory Systems Architecture changes/operations in collaboration with Security, Networking and the Lab CoE/Lab Systems Architecture lead.
  • Provide level III desk side support for GxP desktops and notebook computers.
  • Represents IT on project teams for new implementation or changes to systems, ensuring application support model is in place prior to project completion.
  • Maintains an accurate inventory of laboratory systems.
  • Ensures lifecycle management of laboratory systems, from acquisition to decommissioning and retirement.
  • Develops and documents support plans for laboratory systems. Interacts with Service Desk to coordinate support activities and application knowledge transfer.
  • Involved in on-boarding of new laboratory equipment, including PC setup, installation, backups, antivirus, etc.
  • Ensure data management and backup plans are executed.
  • Responsible for evaluating and testing applications for impact prior to rollout of corporate wide applications and security patches.
  • Work with vendors to troubleshoot any system-related issues.
  • Documents system-related activities for managing applications including support, maintenance and changes in a manner consistent with departmental SOPs.
  • Interacts with company laboratory staff and other departments as required to meet objectives.
  • Provide system troubleshooting and training as needed.
  • Manage changes to validated equipment and systems by following change management and lifecycle procedures in accordance with the ITIL framework.
  • Authors and owns System Administration SOPs.
  • Identifies integration points with other company systems and understands overall technical architecture.
  • Proactively raises technology related risks, issues, and challenges.
  • Lead role in installation applications or liaising with vendor for installation related activities (new implementations and standard upgrades.)
  • Reviews release notes for software upgrades for technical impact.
  • Serves as the liaison with IT Infrastructure for laboratory systems.
  • Ensures appropriate IT controls in place for laboratory systems.

 

 

Minimum Qualifications and Experience:

  • Minimum 8-10 years of progressive levels of system administration and experience in computer systems validation.
  • Minimum of 6 years pharmaceutical, biotechnology or laboratory experience.
  • Service Now experience; Knowledge of IT Tools and processes as it relates to ITIL.
  • Detail-oriented, self-starter and able to work both independently and in a team environment.
  • Strong technical aptitude, demonstrated by experience in implementing, configuring, administering, and testing computer systems.
  • Ability to prioritize competing tasks and projects.
  • Must have experience working directly with senior level staff.

 

 

 

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.

 

 

10585 - Energy Engineer - Cork

Purpose:

The role of the Energy Engineer is to support the site Energy function on behalf of the Engineering Department. The successful candidate will be responsible for ensuring there is a strong safety culture and performance in the management energy on site.

Responsibilities:

  • Project management and support of energy project and initiatives on site.
  • Be proactive in identifying energy improvement initiative and cost savings.
  • Establish and support site department energy teams and champions to ensure energy is a core part of people roles and responsibilities.
  • Support the energy monitoring & metering project and act as SPOC for future projects with an energy focus.
  • Ensure site compliance to ISO 50001.
  • Set up new Fire and safety equipment on maintenance system and implement maintenance routines to ensure high maintenance levels for new building start-ups.
  • Ensure Project Design meets Energy Efficient Design (EED) for New / Upgrades builds to Site, National and company Global Building Standards.
  • Agree Energy Reduction KPI’s with Site IPT’s and ensure compliance to same.
  • Support the site to hit annual energy reduction targets set out by corporate requirements.
  • Conduct site energy awareness events.
  • Carry out inspections and audits of site energy compliance and compliance to ISO 50001 management system.
  • Support and manage the implementation of the site 10-year energy strategy.
  • Analyze the requirement, need and feasibility for renewable energy for the site.
  • Investigate the opportunity of using new technology to manage and reduce energy consumption on site.
  • Use Lean principles across all technical aspects of the process, by deploying company Six Sigma tools.
  • Responsible for driving a culture of Compliance and delivery on time.

 

Minimum Qualifications and Experience:

  • Degree or 3rd Level Qualification (Engineering.)
  • Desirable to have qualification Energy Management.
  • 3+ Yrs. working in a similar role.
  • Desirable evidence of Continuous Professional Development.
  • Must have a thorough understanding and application of engineering principles, concepts, industry practices and standards.
  • Must have meticulous planning and strong communication skills.
  • Ability to work on own initiative to resolve issues.
  • Demonstrated high level of problem-solving skills.
  • Advanced PC skills such as Excel, Word, PowerPoint, MS Project or Primavera (SAP, MIDAS, TRACKWISE and SharePoint use experience also an advantage.)
  • High level of knowledge of Safety, Quality and Environmental requirements.
  • Excellent verbal and written communication skills/presentation skills.
  • Ability to plan, prioritise and effectively manage time, meet deadlines and produce quality deliverables.
  • Proven knowledge, appreciation and experience of working in strongly regulated GMP environment.
  • Understands the typical project life cycle from concept through to qualification and has proven experience in this area.
  • Demonstrated successes in a team environment, such as project teams.

 

10584 - Project Engineer - Cork

Purpose:

The role of the Project Engineer is to support Fire and Safety Systems function in the facility on behalf of the Engineering Department. The successful candidate will be responsible for ensuring there is a strong safety culture and performance in the management of life safety systems. The Fire Safety Project Engineer will report to the company Fire & Safety System Specialist through COE Engineering group.

Responsibilities:

  • Project management of both fire and life safety system improvements driven by continuous improvement, loss prevention recommendations or business needs.
  • Support Fire and Safety Technical Specialist with the execution of fire evacuation drills.
  • Support Fire and Safety Technical Specialist with fire and safety incidents and corrective actions relating to fire safety systems. This will require sound problem-solving skills and methodology.
  • Support change management of fire and safety systems through “Management of change” process as change initiator or approver.
  • Support the closure of planned maintenance works and ensure all unplanned works/ recommendations are assessed and closed appropriately.
  • Set up new Fire and safety equipment on maintenance system and implement maintenance routines to ensure high maintenance levels for new building start-ups.
  • Support fire safety and egress standard compliance with the completion of building walk downs and completion of emergency egress assessment, highlight actions and review until closure.
  • Compile and manage monthly fire and life safety and alarm metrics for forum discussion.
  • Review and assess High Risk Work activity permitted works ensure emergency response plan meets company Safety Standards.
  • Complete GEMBA walkdown with areas owners through leadership standard work process ensuring area, procedures and documentation is aligned with company Quality and Safety standards.
  • Have the capability to prioritise workload to meet site business requirements.
  • Manage costs by forecasting and monitoring spend on Fire/Safety system budgets.
  • Create Snag lists and ensure Projects are completed to a high standard of Quality.
  • Use Lean principles across all technical aspects of the process, by deploying company Six Sigma tools. Responsible for driving a culture of Compliance and delivery on time.

 

Minimum Qualifications and Experience:

  • Degree or 3rd Level Qualification (Engineering.)
  • Desirable to have qualification in Project Management.
  • 5+ Yrs. working in a similar role with relevant experience in the project management of capital projects in a high-tech industry, preferably in Pharma/Bio Pharma. Experience in Fire and Safety systems management would be an advantage.
  • Desirable evidence of Continuous Professional Development
  • Must have a thorough understanding and application of engineering principles, concepts, industry practices and standards.
  • Proven track record in delivering Projects.
  • Must have meticulous planning and strong communication skills.
  • Ability to work on own initiative to resolve issues.
  • Demonstrated high level of problem-solving skills.
  • Advanced PC skills such as Excel, Word, PowerPoint, MS Project or Primavera (SAP, MIDAS, TRACKWISE and SharePoint use experience also an advantage.)
  • High level of knowledge of Safety, Quality and Environmental requirements.
  • Excellent verbal and written communication skills/presentation skills.
  • Ability to plan, prioritise and effectively manage time, meet deadlines and produce quality deliverables.
  • Proven knowledge, appreciation and experience of working in strongly regulated GMP environment.
  • Understands the typical project life cycle from concept through to qualification and has proven experience in this area.
  • Demonstrated successes in a team environment, such as project teams.

 

 

9394 - Automation (Computer Systems) Engineer - Carlow

Purpose:

Reporting to the AIT CSV Lead, specifically responsible for Computer System Validation (CSV). The CSV engineer will be responsible for the development of key AIT quality documents, such as Quality Assurance (QAPs) and test plans, and for ensuing adherence to the QAPs. This candidate will be required to work closely with the AIT teams responsible for the full Automation and IT scope and with vendors / partners with responsibility for delivery of systems.

Responsibilities:

  • Develop and maintain Qualification Plans and Test Plans, aligned with the overall project C&Q plan and with the leveraging strategy.
  • Develop templates for all 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 the QAIT function and ensure their requirements are met in all deliverables.
  • Align with the company HPV program: leverage existing documents & expertise where feasible.
  • Approver of all AIT SDLC deliverables, ensuring compliance with standards.
  • Provide FAT oversight and perform leveraging assessments.
  • Provide guidance and support to AIT team members tasked with delivery of SDLC documents.
  • 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 3 years’ experience in a similar role, ideally in the Pharmaceutical industry.
  • Expert knowledge of GAMP5.
  • Strong experience in one or all of the following systems: DeltaV, PCS7 (or other PLC/SCADA), OSI PI.
  • Fluent in English, written and verbal.

 

 

9859077 – QA Specialist IV - Dublin

Responsibilities:

  • Use deep process knowledge and experience to assist business partners with the creation, review, approval and closure of deviations, investigations, CAPAs, change controls and associated quality risk assessments in compliance with internal and external requirements.
  • Proactively identify opportunities and support continuous improvement of enterprise QMS processes and associated systems.
  • On-time completion of assigned projects.
  • Monitor QMS process performance to identify trends and best practices on an ongoing basis (audits, visual management systems, dashboards, status reports etc.)
  • Author, review and approve of QMS procedural documentation and work instructions.
  • Create and deliver Quality Systems training (process and technical.)
  • Compile, analyze and present QMS monthly and quarterly metrics at Quality Management Review.
  • System user access management.
  • Participate in inspection readiness activities and internal/external audits and inspections.
  • Other duties required to support the growing Quality organization as assigned.

 

Minimum Qualifications and Experience:

  • Bachelor’s degree in a technical or life sciences discipline (ex. Chemistry, Biology, Biotechnology.)
  • 5 years’ + QA experience within the pharmaceutical industry or related field.
  • Significant, direct experience with development and approval of a minimum of two of the following: Deviations, CAPAs, Change Controls and quality risk assessments.
  • In-depth knowledge of global cGxP requirements for quality systems.
  • Experience working with stakeholders in pre-commercial, manufacturing, laboratory and distribution functions.
  • Excellent communication skills with all levels of the organization and Health Authority representatives.
  • Demonstrated critical thinking and problem-solving skills.
  • High level of organization and attention to detail to plan, execute and track completion of deliverables.
  • Able to prioritize and manage workload and manage shifting priorities based on criticality to ensure commitments are met.
  • Knowledge of medical device quality system requirements desired.
  • Direct experience with TrackWise desired.
  • Project Management and Lean Six Sigma certifications a plus.
  • Qualified Person designation a plus.

 

 

9851946 – MCS Automation Commissioning Engineer - Dublin

Purpose:

The MCS Automation Commissioning Engineer shall be responsible, as part of the client team, for the development and delivery of the Automation MCS System (Delta V) to enable the New Product, commissioning and qualification on our Bulk Drug Substance manufacturing facility. The successful applicant will participate in the development and implementation of an MCS Solutions (Upstream & Downstream) in line with S88 standards for the BDS plant, and will manage the delivery of robust, compliant and cost effective MCS Solutions in line with agreed timelines for these key New Product capital project.

Responsibilities:

  • The Automation Commissioning Engineer will also co-ordinate the development of the Automation software and hardware to ensure alignment with various New Product Introduction schedules to enable equipment FAT’s, on-site SAT’s, commissioning and validation of the process systems to meet these projects schedules.
  • Works closely together with the other Automation Engineer to ensure deliverables are ready in time for the different milestones throughout the New Product Introduction projects.
  • Works closely together with the other Automation Engineer to ensure the defined standards are followed consistently in the project and the library modules are used as intended.
  • The Automation Commissioning Engineer will support the company’s Commissioning Qualification and Validation (CQV) Teams in Shakedown and Verification of the DeltaV Software.
  • Design, code and test DeltaV software changes identified during Commissioning.

 

Minimum Qualifications and Experience:

  • Degree level qualification in chemical, electrical or mechanical engineering, or equivalent.
  • of 5 years’ experience in the Biotech environment delivering Automation design / commission / start-up.
  • of 5 years’ experience with DeltaV.
  • Has process understanding of production processes used like upstream, downstream processes or CIP, and/or has a deep knowledge of automation system architectures.
  • Ability to constructively challenge, defend and present technical aspects of system design.

 

 

10528 - Scientific Technical Specialist - Cork

Purpose:

Reporting to the Sterile IPT Engineering Lead, the Technicial Specialist will be responsible for providing operational support to Sterile Manufacturing facility. Trouble shoots, investigates and documents process issues and deviations. Identify and implement process improvement and optimization opportunities.

Responsibilities:

  • Provides technical leadership and supports execution of EHS policies and procedures.
  • Ensures that all dalily safety, quality, environment and financial goals for a campaign are addressed.
  • Participate in and closure of HAZOP recommendations.
  • Ensures that all process atypical events are thoroughly investigated, root cause identified and eliminated. Deviations should be closed in a timely manner.
  • As requested provide training and mentoring to new engineers.
  • Identify and implement improvements in processes and business systems utilizing LSS tools and problem-solving techniques.
  • Maintain process knowledge retention files for assigned processes and actively utilise Knowledge Management VTN system.
  • Technical Support for Process, Engineering & Maintenance lead for Engineering issues.
  • Engineering support for Manufacturing and Process issues.
  • Researches business and technical issues to establish what is being done and where improvements are possible.
  • Maintains professional and technical knowledge by attending educational seminars and trade shows, reviewing professional publications and analyzing new trends.
  • Generates capital equipment appropriations required for new process implementation or facilities and controls expenditures to ensure compliance with timing and budget requirements.
  • Provides technical leadership of cross functional teams on many different projects/ process improvements and resolves inter-functional issues.
  • Ensures the documentation of project and program activities and deliverables.
  • Manage multiple outside vendors and contractors.

 

Minimum Qualifications and Experience:

  • Hold a third level qualification in Engineering or Science discipline.
  • GMP and cGMP training topics.
  • Change Control.
  • Plant layout and design.
  • Plant processing and equipment.
  • Safety and Environmental procedures.
  • Documentation systems.
  • Business process re-engineering.
  • Quality Policies and Procedures.
  • Computer skills – Powerpoint, Excel, Word, 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.

 

 

10565 - Validation Analyst - Carlow

Purpose:

Responsible for providing process, technical, and validation support operations including ongoing support of manufacturing processes and support for new product introduction. Accountable for analytical/engineering studies associated with the development of new components, products, processes systems and facilities. Co-ordination, design and execution of equipment qualification and validation as required.

Responsibilities:

  • Serve as technical and/or validation support as required for manufacturing and new product introduction.
  • Design/Author/Review/Approve/Execute process development studies in support of new product introduction and ongoing manufacturing support.
  • Provide technical input into quality notification by authoring/reviewing/approving investigations.
  • Execution of equipment commissioning and qualification programs.
  • Execution of equipment/qualification validation programs; including re-qualification and revalidation.
  • Design/Author/Review/Approve/Execute qualification/validation documentation and studies in line with the standard approval process.
  • Perform data analysis and make informed decisions/recommendations around conclusions reached from data analysis.
  • Support continuous improvement through Lean Six Sigma methodologies.
  • Leading and active participation in projects, system failure investigations and investigation reports.
  • Execution/development of change controls.
  • 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.
  • Serve as technical engineering representative for internal technical group discussions and represent the company at global technical forums.
  • Participate and/or lead cross functional or single function teams including liaising with vendors or above site groups.
  • Drive compliance of 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, 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.
  • 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.
  • Relevant experience (5+ years) and a particular skill set in area of expertise that adds value to the business; ideally in a manufacturing, preferably in a GMP setting.
  • 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.
  • Proficiency in Microsoft Office and job-related computer applications required.
  • Lean Six Sigma Methodology experience desired.
  • 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 departments as they relate to one’s own department, understanding the business processes ones department supports.

 

 

10561 - Automation Engineer - Carlow

Responsibilities:

  • 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 to ensure deliverables meet project requirements.
  • 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 3 years’ experience in a similar role, ideally in the Pharmaceutical industry.
  • Strong experience in one or all of the following systems: Siemens Desigo CC/Insight, Xworks and PX controllers. Utility systems experience would be an advantage on Chilled water, Hot water and steam generation systems.
  • 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.

 

 

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.

 

 

8545 - Compliance Specialist - Carlow

Purpose:

Reviews, verifies and analyzes information related to construction project activities in the field as summarized below. Measure impact on GES Capital Projects.

Responsibilities:

  • Support project management team from design through financial close–out. Be knowledgeable of construction industry risks and current events, especially as it relates to contracted firms.
  • Facilitate accurate invoice processing by checking accuracy of invoices, in coordination with responsible Project Manager. Ensuring payment/application of approved credits through Source to Settle Process. In most cases, audits will be retroactive but complete in advance of project closeout.
  • Utilize audit standards and procedures and GES Practices and Procedures to ensure compliance with contractual documents for both reimbursable Services and Subcontract/Equipment Costs. Understand the contract scope terms and conditions and apply to downstream processes, such as Change Management and Invoicing.
    • EPCM Services;
      • Travel Costs.
      • Miscellaneous Costs.
      • Safety Incentive Tracking.
      • Rental Equipment.
    • Subcontract Agreement terms and conditions in place, including labour rate breakdowns.
    • Subcontract Field Change Documents.
    • Subcontract Payments.
    • Insurance Coverage.
    • VAT.
    • Capitalization.
  • Review analyze and report on all items that are out of compliance in an agreed format. Invoices summaries will be provided to include: invoice details, date audited, status of resolution, and type of deduction.
  • Creates and maintains audit work papers per audit cycle. Understands Contract Scope, terms and conditions, and applies to downstream processes. Makes recommendations for best practices.
  • Provides audit management with recommendations on audit scope.
  • Responds to internal and external customers as needed in a business partnering manner.
  • Consolidates results and recommendations in audit database repository and follows-up on status. Communicates, in a timely manner, with responsible Project Team members.
  • Knowledge of local Taxes.
  • Assist with the development of desk-top auditing functionality.
  • Any other duties commensurate with the role.

 

Minimum Qualifications and Experience:

  • Degree in Accounting, Engineering, Finance, or other relevant discipline.
  • Experience 5+ of external or internal audit and/or construction industry experience.
  • Advanced academic training or specialized knowledge in relevant areas may be considered in lieu of some or all experience.
  • Incumbent must have the ability to work both independently and in a team environment and be able to effectively interact with all levels of management.
  • Has the ability to research invoice activity and experience with construction project execution (experience with bid and award documents, construction and engineering contract agreements, change management, invoicing, cost reporting, and schedule.)
  • Solid understanding and experience of Internal Controls, Risk Management and External or Internal Audit / Compliance discipline.
  • Excellent analytical and communication (verbal, written) skills.
  • Proficient in Microsoft Word and Excel.
  • SAP work experience strongly preferred.
  • Exposure to EPCM Business Model in the Pharma sector.

 

10530 - Maintenance Engineer - Cork

Responsibilities:

  • Support day to day planning and implementation of maintenance work both routine and corrective.
  • Work with the craft, process and site utilities functional areas to identify re-occurring equipment issues and implement corrective plans.
  • Lead equipment breakdown and EHS investigations.
  • Ensure spare parts are linked correctly to the parent equipment.
  • Ensure correct spares are in stock.
  • Work with the projects team to ensure maintenance and reliability are considered as part of the design phase.
  • Introduce predictive maintenance techniques where they add value.
  • Proven record of co-ordinating, leading and implementing FMECA (Failure Modes, Effects and Criticality Analysis) studies for process equipment.
  • Proven track record of reviewing and simplifying PM’s through PM optimisation programme along with generating or updating associated procedures and work instructions simplifying the process.
  • Knowledge of root cause analysis techniques for equipment troubleshooting and implementation of correctives actions.
  • Knowledge of process and utilities equipment.
  • Work within a current Good Manufacturing Practices environment (cGMPs.)
  • Participate in engineering team initiatives on an as needed basis.
  • Ensure that the company’s quality and engineering standards are adhered to.
  • Ensure compliance to the company’s Global Engineering Standards.

 

Minimum Qualifications and Experience:

  • Degree in chemical or mechanical engineering.
  • 3+ years process / project management experience.
  • Good Written and verbal communication skills.
  • Identify key stakeholders and develop a relationship of trust.
  • Must have a good appreciation for designing systems within a GMP environment.
  • Demonstrated capability to communicate effectively across multiple teams.
  • Thorough understanding and application of engineering principles, concepts, industry practices and standards.
  • Lean Six Sigma qualification or experience of application of Lean principles is an advantage.
  • Good knowledge of GMP / FDA regulatory requirements and current Health and Safety Regulations legislation.
  • Strong communication skills, a confident and effective decision maker, with a proven leadership ability to influence others.
  • Must have the ability to recognise deviations from accepted practice as required and drive and deliver solutions to identified issues.
  • Team player, with a flexible approach but also able to work under own initiative and remove road blocks.
  • Strong verbal, technical writing, project management and interpersonal skills are required.

 

2020-312 - QC Chemist - Waterford City

Purpose:

You will contribute to the continued success of our QC department by providing analytical services to support our diverse manufacturing operations. Engage with our Continuous Improvement programme to share your ideas and experience to further optimise our laboratory function. Comply with all regulatory and safety guidelines to protect yourself, your colleagues and our patients.

Responsibilities:

  • Provide analytical chemistry services and support to Site.
  • Effective interaction with other departments on matters related to raw materials, intermediates and finished batch releases. In particular, close contact maintained with Quality Assurance Production, Engineering and Planners.
  • Maintain, update and issue chemical methods, specifications and SOP’s in compliance to pharmacopoeial and regulatory requirements.
  • Assist with training of the analysts in areas of expertise and knowledge and in new methods, SOP’s and updates.
  • Trend such results, record on COA’s where required and complete OOS’s investigations on a timely basis.
  • Support new product introduction projects.

 

Minimum Qualifications and Experience:

  • Degree in Science (Chemistry or Biochemistry preferred.) Post-graduate studies as appropriate to augment primary degree.
  • Operational experience of quality laboratories in a fast moving manufacturing environment.
  • Detailed knowledge of quality management systems, pharmaceutical manufacturing operations, requirements for cGLP, pharmacopoeial methods and stability.
  • Understand relevant quality/compliance regulations.
  • Can manage projects to plan/budget.

 

 

9851946 - Automation Engineer - Dublin

Responsibilities:

  • Responsible, as part of the team, for the development and delivery of the Automation MCS System (Delta V) to enable the New Product, commissioning and qualification on our Bulk Drug Substance manufacturing facility.
  • The successful applicant will participate in the development and implementation of an MCS Solutions (Upstream & Downstream) in line with S88 standards for the BDS plant.
  • Manage the delivery of robust, compliant and cost effective MCS Solutions in line with agreed timelines for these key New Product capital project.

 

Minimum Qualifications and Experience:

  • Degree level qualification in chemical, electrical or mechanical engineering, or equivalent.
  • of 5 years’ experience in the Biotech environment delivering Automation design / commission / start-up.
  • of 5 years’ experience with DeltaV.
  • Has process understanding of production processes used like upstream, downstream processes or CIP, and/or has a deep knowledge of automation system architectures.
  • Ability to constructively challenge, defend and present technical aspects of system design.

 

 

9828678 - QC Micro Analyst - Dublin

Responsibilities:

  • Perform laboratory testing such as endotoxin testing, environmental monitoring, bioburden testing and water quality monitoring.
  • Ensure results are recorded in a timely and accurate fashion.
  • Ensure that any out of specification results are investigated according to site procedures.
  • Completion of testing documentation / LIMS.

 

Minimum Qualifications and Experience:

  • Degree in Microbiology or a related discipline preferable.
  • A minimum of 2 years prior experience working in a GLP laboratory environment.
  • Excellent written and verbal communication skills.
  • Ability to work well in a team.
  • This is a shift role.

 

 

10517 - CQV Equipment Engineer - Dublin

Responsibilities:

  • Ensure compliance to all regulatory GMP, Safety and Environmental requirements.
  • Participate in Mechanical Completion walkdowns.
  • Support Commissioning and Qualification activities and lead troubleshooting efforts.
  • 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.

 

Minimum Qualifications and Experience:

  • Level 8 Qualification in Engineering discipline or equivalent.
  • 5+ years’ experience in a process plant or other industry in a maintenance or operations support role.
  • Self-motivated with high attention to detail.
  • Strong communications, organizational and analytical skills.
  • Attention to detail.
  • 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.

 

 

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.

 

 

 

10424 - Drafter - Cork

Purpose:

This role will be to provide support to the existing Cork Drawing Office and Engineering Project teams in the preparation of CAD drawings. As an integral part of a design team you will be responsible for developing new drawings, amending existing drawings to reflect as built conditions in the field. Candidates should be motivated and enthusiastic, have the ability to work on their own initiative and be able to meet deadlines and liaise successfully with clients.

Responsibilities:

  • Produce and amend drawings in line with the site Drawing Management System.
  • Participate in all activities within the drawing office. Ensure that all architectural, electrical, mechanical, civil, instrumentation, general layout drawings are at the correct revision.
  • Ensure that all change management updates are captured and reflected on the appropriate drawings.
  • Ensure that drawing documentation packages issued from projects are correct and are in line with site standards.
  • Ensure compliance for all drawings and procedures that fall under the responsibility of the company.
  • Assist with the development of draughting and documentation staff as required.
  • Ensure all drawings are stored correctly in electronic and paper format and that all drawings issued and received by the department.
  • Carrying as built surveys of existing P&ID drawings and ensure current drawings reflect the as built site conditions.
  • Work closely with the Drawing Office Manager and Engineering Project Teams to develop solutions.
  • Ensure all activities are carried out in line with Company QA & EHS Requirements and Procedures. Play an active role in the CAD Standards/Standard Operating Procedures input.

 

Minimum Qualifications and Experience:

  • Minimum of Higher National Diploma or Higher National Certificate qualification in Engineering.
  • 5+ Yrs Industry Experience with 3+ Yrs working in a similar role.
  • Minimum of 5 Yrs Experience with using AutoCad.
  • Good Written and verbal communication skills.
  • Interact with above site personnel to understand changes and promote the site.
  • Solid engineering acumen.
  • Demonstrated capability to communicate effectively across multiple teams.
  • Good knowledge of GMP / FDA regulatory requirements and current Health and Safety Regulations legislation.
  • Excellent presentation and written / verbal communication skills.
  • Team player, with a flexible approach.
  • Ability to work autonomously.
  • High Attention to detail and accuracy.
  • Experience with 3D modelling software packages would be an advantage.
  • The ability to meet deadlines.

 

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.

 

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.

 

10207 – Quality Control Specialist - Carlow

Purpose:

Manages QA Compliance related activities relating to Quality Systems and QA support of GMP departments to ensure processes comply with corporate and regulatory requirements to facilitate product release. Provide oversight for QA compliance specialists, provide expertise, trouble-shooting, training and support to Quality System and Compliance personnel. Ensures inspection readiness to support all scheduled activities, consistent with the company’s requirements to ensure compliance, safety and reliable supply to our customers.

Responsibilities:

  • Support leadership activities including selection, development, coaching, and day to day management. Ensure that the team receives appropriate resources and programs to develop technical and other skills, to complete their jobs whilst stimulating personal growth and development in line with role. Develop and maintain training programs.
  • Manage a team of specialists and be accountable for people aspects, such as coaching, talent development, recruitment and performance management.
  • Work collaboratively to drive a safe and compliant culture in Carlow.
  • Provide quality compliance guidance and apply expertise and critical thinking to help to resolve any potential compliance issues.
  • Drive and promote a culture of compliance 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.
  • Provide strong and visible support to the Quality systems.
  • Manage quality-related matters, specific to area of responsibility,
  • Establish compliance direction for the site by ensuring adherence to divisional policies and guidelines as well as regulatory requirements. Proactively evaluate site compliance against emerging regulatory trends.
  • Ensure the Quality Management Systems are accurate and complete and ensure the Quality Management System is reviewed on a continuous basis. Be an advocate of continuous improvement in the Quality Management Systems.
  • Ensure that Quality Operations responsibilities for SOPs, change control documentation and other Quality Assurance related systems are properly implemented, conducted and documented.
  • Participate in internal audits and external audits as appropriate. Review the results of Regulatory Inspections and address issues.
  • Responsible for approving appropriate quality-related documents.
  • Manage and contribute to the achievements of department productivity and quality goals.
  • Perform delegated duties and responsibilities of the Associate Director of Quality Systems and Compliance in their absence.
  • May be required to perform other duties as assigned.

 

 

Minimum Qualifications and Experience:

  • Bachelors Degree or higher preferred; ideally in a related Science discipline.
  • Ideally a Qualified Person course designed to meet the requirements for theoretical training as detailed in EC Directives 2001/82/EC and 2001/83/EC.
  • Considerable experience in a comparable role; would typically have experience operating in a management role in a similar sized organization, adding considerable value to the business; ideally in a manufacturing, preferably GMP setting.
  • Knowledge of regulatory/code requirements to Irish, European and International Codes, Standards and Practices.
  • Knowledge of cGMP.
  • Knowledge of Equipment and process validation.
  • Quality Systems.
  • Proficiency in Microsoft Office and job related computer applications required.
  • SAP knowledge and experience preferred.
  • Report, standards, policy writing skills required.
  • Lean Six Sigma Methodology experience desired.
  • Understand the specific responsibilities of all Carlow departments as they relate to one’s own department, understanding the business processes ones department supports.
  • Effective communication, presentation and interpersonal skills, to interface effectively with all levels of colleagues and with external customers in a team orientated manner.
  • Planning and scheduling skills.
  • Flexible approach.

 

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.

 

 

2019-300 - Senior EHS Specialist - Cork

Purpose:

This role is part of the site EHS team who is creating and building original and novel pharmaceuticals to address unmet medical needs. We need proven leadership abilities and experience in EHS execution preferably within highly regulated industry such as pharmaceuticals, medical device, food and drink, or alternatively within EHS consulting or EHS agencies. The successful candidate will need to solve problems and to anticipate and minimise workplace safety and environmental risks. We are interested in a candidate who can effectively prioritise, ensure regulatory compliance, and drive continuous performance improvement efforts.

 

Responsibilities:

  • Demonstrates collaboration with site colleagues to ensure a safe by choice culture.
  • Drives EHS improvements with clear outcomes.
  • Provides support for management of change, incident investigation, EHS standards compliance, auditing and capital project work as assigned.
  • With a deep knowledge of EHS regulations and their applicability, develops EHS procedures, guidelines and training programs as assigned.
  • Leads and supports action oriented EHS teams.
  • Assures completion of regulatory submissions and notifications required to maintain compliance with national EHS requirements.
  • Leads EHS agency inspections and regulatory advocacy.
  • Performs responsibilities and addresses problems with limited supervision.

 

 

Minimum Qualifications and Experience:

  • Bachelor’s Degree required in Engineering or Science; Safety or Environmental related technical discipline is an advantage.
  • Minimum of 7 years of applied professional EHS work experience.
  • Preferred proficiency in the areas of environmental compliance and critical thinking, project management, problem solving.

 

 

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.

 

 

2019-298 - Process Engineer - Waterford City

Responsibilities:

  • Liaise with external and internal customers, suppliers and agencies to define and improve manufacturing and development operations.
  • Optimisation of manufacturing and development operations.
  • Identification & implementation of opportunities for improvements.
  • Assist in the implementation of capital projects.
  • Act as process lead for inspection development.
  • Lead technical problem resolution & RCA for all manufacturing operations, in conjunction with cross functional teams.
  • Implementation and monitoring of performance metrics.
  • Lead cycle time reduction initiatives in conjunction with manufacturing teams.
  • Implementation of best practice.
  • Process development programme design / plant trials, execution and implementation.
  • Constantly seeking to challenge operational standards and driving continuous improvement.

 

Minimum Qualifications and Experience:

  • Degree in Chemical, Industrial or equivalent Engineering discipline.
  • Minimum 5 years’ experience in an Engineering role.
  • 1 – 2 years’ experience of sterile pharmaceutical manufacturing environment.
  • Technical knowledge of relevant manufacturing technology.
  • Detailed knowledge of cGMP.

 

 

9899 - Project Scheduler - Cork

Purpose:

The Project Scheduler will be responsible for developing and maintaining a detailed, resource-mapped Primavera project schedule for the post-IOQ start-up site activities and MES / EBR capital project activities for a new vaccine facility. This role will involve working with the project manager, the automation / IT lead and a cross-functional site team as well as interacting with the capital project team to ensure tight integration with that aspect of the project. This is an opportunity for an experienced scheduler to gain further experience of the extended project lifecycle from capital project concept design through to completion of PPQ batches on both the capital and client side of a strategic and high-profile biopharmaceutical project.

 

Responsibilities:

  • Transfer the existing start-up schedule from Microsoft Project to Primavera.
  • Chair or assist with interactive scheduling workshops with various individuals and teams, within and outside the site, to further develop the schedule.
  • Develop a close working relationship with the scheduler on the capital project to identify critical common milestones and workload peaks and to ensure a tightly integrated schedule.
  • Monitor progress and provide timely updates showing impact on milestones.
  • Identify mitigations for impending delays and risks.
  • Provide weekly updates to the project manager, leadership team and site project management office using established reporting tools.

 

Minimum Qualifications and Experience:

  • Level 7 or 8 degree in a relevant scientific or technical discipline.
  • Project Management Professional or similar qualification.
  • 5 to 8 years working in a similar role in a pharmaceutical or preferably a biopharmaceutical environment with at least one major project involving implementation of MES and MBR.
  • Proficiency in Primavera scheduling tool.
  • Proficiency in Microsoft Project scheduling tool.
  • Proficiency as a user in Microsoft Excel, Powerpoint, Word, Outlook, Sharepoint.
  • Excellent interpersonal and communication skills, both written and verbal.
  • Ability to work on own initiative to resolve issues.
  • Knowledge of clean room installation essential.

 

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.

 

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.

 

9846 - QA IT Specialist - Carlow

Purpose:

The successful candidate will join the QA IT team to provide independent oversight and support for the computerised systems being implemented and modified as part of the site expansion project to ensure compliance with regulatory expectations and company Computer Systems Validation (CSV), System Development Lifecycle (SDLC), Cyber Security and Data Integrity requirements. The QA IT specialist will support a number of shopfloor system, including DeltaV, PLC/SCADA systems, OSI PI and MES.

 

Responsibilities:

  • Providing independent quality review and approval of system lifecycle documentation, such as plans, requirements, risk assessments, protocols and reports for new and modified systems.
  • Providing independent quality review and approval of system changes.
  • Supporting and approving computerised systems investigations and test deviations.
  • Ensuring consistent approach to qualification, change and deviation management across systems being implemented on the project.
  • 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.
  • Working 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.
  • DeltaV, PLC/SCADA, OSI PI and PAS-X experience will be an advantage.

 

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.

 

9578 - Quality Technician - Carlow

Responsibilities:

  • Perform all Lab functions in compliance with cGMP.
  • Effective interaction with other departments on matters related to raw materials, intermediates and finished batch release.
  • Maintain , update and issue chemical test specifications and SOPs in compliance to pharmacopoeial and regulatory requirements.
  • Received and manage samples that come into the lab for release and stability testing.
  • Follow written procedures for analytical testing techniques.
  • Provide lab support including routine equipment maintenance.
  • Ensure training is current and all job functions performed.
  • Support new product introduction projects.

 

Minimum Qualifications and Experience:

  • Bachelor’s degree – ideally in Chemistry, analytical chemistry or a related Science discipline or relevant experience.
  • 2-4 years of experience in a pharmaceutical laboratory.
  • A good working knowledge of analytical systems and software is desirable.
  • A good knowledge of cGMP, GLP, Quality Management Systems.

 

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.

 

9459 - Project Manager - Tipperary

Purpose:

A vacancy exists within our Global Engineering Solutions (GES) group for a Client Side Project Engineer / Construction Manager supporting GES capital projects in Tipperary. The successful candidate will have several years’ experience working in the pharmaceutical or similar Industry. Reporting to the GES Project Manager based at the Tipperary Site. The Engineer will be a key member of the project management team on a $100MM capital project. The Engineer may also work on other projects as needed by the business. 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:

  • Ensure there is a strong safety culture and performance in the field execution of project deliverables and that appropriate stage gate controls are in place for all works, coaches project team wrt to safety , is involved in any investigations (near miss etc.)
  • Works closely with CM from EPCM to develop construction team.
  • Attends field walk downs as client CM Representative to ensure that appropriate standards are being met with installations.
  • Completes early walk downs on systems and works with overall construction team to resolve punch lists based on priorities.
  • For construction acts as an interface with Tipperary site to address and resolve any conflicts.
  • Attends and provides inputs to Interactive Pull Planning Workshops with appointed contractors and other stakeholders to plan out construction and energisation activities in a schedule critical project, identifies any constraints and works to remove these and other barriers.
  • Ensure that Lean Construction Tools and Methodologies are being implemented in the field (Tacht, Last Planner & Pull Plan Scheduling, Target Value Design and Construction, Integrated Project Safety Team Structure, Right First Time approach.)
  • Ensures that EPCM has appropriate stage gate approach in place to ensure rigour in allowing systems pass from Testing – Construction Completion – Energisation.
  • Ensure Project Quality Standards are implemented and that documentation requirements met.
  • Coordinate the project construction programme, incorporating
    • Enabling CSA works, Main CSA Works, cleanroom, Clean & Black Utilities generation/ Distribution, Process Equipment Installation, office and warehouse fit out.
  • Attends daily tier meetings / weekly co-ordination meetings regarding construction.
  • Reviews and approves any site field instructions and manages commercial contract variations with EPCM, acts as a delegate for the Project Manager.
  • Completes daily walkthrough of site for safety and checks on progress etc.
  • Manage project changes in construction and ensure all are captured, documented and assessed for Quality / Safety / Cost or schedule impacts.
  • Assist with the coordination of design, construction, commissioning and qualification, schedule and cost in collaboration with other project team members, company personnel, outside contractors and vendors.
  • Track and report construction progress as required against project deliverables.

 

Minimum Qualifications and Experience:

  • Must have as a minimum a 3rd level Degree in a relevant discipline.
  • A minimum of 10 years+ of relevant experience in capital projects preferably in Pharm/Bio Pharm.
  • Proven level of experience in delivering significant capital projects within the pharmaceutical sector > €80MM.
  • Ability to sequence critical activities in planning work for construction phase.
  • 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.
  • Proven knowledge, appreciation and experience of working with Lean Construction Tools and Methodologies.
  • Demonstrated achievements within multi-functional teams.

 

2019-276 - QA Specialist - Waterford City

Purpose:

Reporting directly to the Quality Assurance Team Leader, as a critical leader for the company, you will play an integral role in providing day to day Quality and compliance support to the sterile manufacturing operations.

Responsibilities:

  • Working as part of the Quality Assurance team on site ensuring products are manufactured, stored and packaged in accordance with cGMP
  • Implement and support a batch release system in the QA function of Sterile Manufacturing
  • Support the development of GMP training packages and delivery of training
  • Participate in the preparation and review of procedures and batch documentation
  • Review and approval of deviation, CAPA’s, quality events and tasks
  • Ensure the quality system at the company is effectively implemented and maintained
  • Acts as Quality Point person for systems / processes providing guidance / feedback on quality issues
  • Perform timely review of documentation / investigations / reports highlighting and assisting in the resolution of concerns commensurate with the risk
  • Work with relevant departments to ensure timely closure of quality actions / findings
  • Actively contribute to continuous improvement initiatives
  • Conduct duties in a safe manner and report all safety issues or concerns

 

Minimum Qualifications and Experience:

  • Bachelor’s degree in a science related subject is essential
  • 3 years experience in a manufacturing environment, sterile experience is preferable
  • Effective technical knowledge of sterile manufacturing processes
  • Operational experience of quality systems in a dynamic manufacturing environment
  • 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
  • Understands KPI’s for the team and site
  • Must be able to respond quickly to unplanned events, technical issues and changing needs from development programs
  • All applicants must be open to shift work

 

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.

 

9060112 - Investigation Specialist - Dublin

Purpose:

This position is responsible for conducting and documenting investigations associated with the company’s Quality Control Laboratory – Laboratory Investigation Reports (LIRs) and deviations. In this role, you should have excellent investigational, root cause analysis and problem-solving skills. Relationship building, a high attention to detail and excellent verbal and written communications skills are vital to success in the role

 

Responsibilities:

  • Conduct and document investigations associated with the company’s Quality Control Laboratory in a complaint and timely manner.
  • Conduct root cause analysis.
  • Develop and document Corrective and Preventative Actions (CAPAs) and associated CAPA Effectiveness Checks (EC).
  • Track and trend investigations and associated root cause types.
  • Provide training and mentoring for Laboratory 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 LIR, 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:

  • At least 5 years’ working in Pharmaceutical quality operations
  • Degree in science/pharmaceutical related subject
  • Knowledge and understanding of GMP standards
  • Strong problem solving experience
  • Familiar with continuous improvement initiatives
  • High level of experience of conducting Laboratory Investigations, root cause analysis and CAPA development.
  • 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

 

9166 - HVAC Refrigeration Engineer - Carlow

Purpose:

The HVAC/Refrigeration Engineer will perform an integral role in the development of the company’s drug product facility. The Engineer will take ownership for the HVAC and refrigeration systems on site (such as, but not limited to, ISO Grade A, C and D environments; the integration of the required supporting utilities; clean steam, chilled water, heating hot water, instrument air, 2-8degC coldrooms, ambient warehousing, fumehoods, incubators, Process Chillers and local refrigeration systems). They will 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 HVAC/Refrigeration 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 (HVAC) 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 HVAC/Refrigeration 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.
  • 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 company Six Sigma tools and support implementation of Model Area within operations from the start.
  • Expected travel – 20%

 

Minimum Qualifications and Experience:

  • General
  • Demonstrating energy and enthusiasm, the HVAC/Refrigeration 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 (ideally working with GMP HVAC) 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.
  • Technical
  • SME (subject matter expert) in HVAC/Refrigeration engineering lifecycle (design, through to sustaining operations; including ARM – asset reliability maintenance).
  • SME in HVAC and refrigeration (cleanroom environments, HVAC balancing), mechanical, electrical, fluid and pneumatic utility systems, 2-8degC coldrooms, ambient warehousing, fumehoods, incubators, Process Chillers and local refrigeration 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.
  • People
  • Ability to participate in and lead highly-effective teams.
  • The desire to continuously learn, improve and develop.
  • A great communicator, decisive decision-maker with a proven ability to deliver excellence
  • Strong leadership and interpersonal skills.
  • Willingness to support the team and a strong focus on delivering excellence.
  • A passion for coaching others by sharing your skill-set and expertise.
  • High personal integrity, credibility, energy and flexibility.
  • Model the company leadership behaviours and use the MPS principles to achieve project success.
  • 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.
  • Education
  • Degree qualification or equivalent (Science, Engineering, Technical).
  • Experience in manufacturing in a GMP HVAC environment utilizing ISO 14644-1 classifications (such as Grade A, C and D.)
  • Evidence of continuous professional development is desirable.

 

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

 

9060112 - Laboratory Investigation Specialist - Dublin

Description:

This position is responsible for conducting and documenting investigations associated with the company’s Quality Control Laboratory – Laboratory Investigation Reports (LIRs) and deviations In this role, you should have excellent investigational, root cause analysis and problem-solving skills. Relationship building, a high attention to detail and excellent verbal and written communications skills are vital to success in the role.

Responsibilities:

  • Conduct and document investigations associated with the company’s Quality Control Laboratory in a complaint and timely manner
  • Conduct root cause analysis
  • Develop and document Corrective and Preventative Actions (CAPAs) and associated CAPA
  • Effectiveness Checks (EC)
  • Track and trend investigations and associated root cause types
  • Provide training and mentoring for Laboratory 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 LIR, 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:

  • At least 5 years’ working in Pharmaceutical quality operations
  • Degree in science/pharmaceutical related subject
  • Knowledge and understanding of GMP standards
  • Strong problem solving experience
  • Familiar with continuous improvement initiatives
  • High level of experience of conducting Laboratory Investigations, root cause analysis and CAPA development
  • 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

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