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

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.

 

 

9745694 – QC 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.

 

 

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.

 

 

 

10351 - QC Specialist - Waterford City

Purpose:

Performs and reviews all routine and non-routine testing and project work to ensure processes and end products comply with corporate and regulatory requirements to facilitate product release. Ensure that objectives are effectively achieved, consistent with company requirements to ensure compliance, safety and reliable supply to our customers.

Responsibilities:

  • Work as directed by the Quality Control Manager / Associate Director, according to Company safety policies, cGMP and cGLP. Required to drive compliance with company global policies, procedures and guidelines and regulatory requirements and execute Good Manufacturing Practices (cGMP) in the performance of day to day activities and all applicable job functions.
  • 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.
  • Develop, implement and maintain procedures that comply with appropriate regulatory requirements.
  • Ensure that all Quality Systems within the department are adhered to on a daily basis.
  • Operate as part of the QC team performing the allocated testing and laboratory based duties.
  • Participate in method transfers and provide technical expertise and troubleshooting to support analysis.
  • Ensure timely completion of all assigned data processing and reviewing.
  • Ensure timely completion of Laboratory Investigation Reports and deviations through site procedures.
  • Participate in the timely generation of trend data, investigations, nonconformances, validation protocols, reports in support of method validation/verifications and equipment qualifications.
  • Participate in QC Tier 1 daily meetings and ensure effective communication of testing progress, deviations etc.
  • Peer review testing documentation and ensuring data integrity compliance and QC Right First Time KPIs are achieved.
  • Where applicable, review, approve and trend test results.
  • Participate in the laboratory aspects of OOS investigations.
  • Provide support with audit/inspection requirements to ensure department compliance/readiness.
  • Participate in internal and external audits and inspections, taking the role of auditee for assigned areas of responsibility.
  • Drive continuous improvement, perform root cause analysis on system failures and substandard equipment performance, using standard tools and methods, to resolve machine and system issues e.g. FMEA, Fishbone diagrams, 5 why’s etc.
  • 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 related discipline.
  • Knowledge of regulatory/ code requirements to Irish, European and International Codes, Standards and Practices.
  • Knowledge of cGMP.
  • Laboratory Quality Systems.
  • Proficiency in Microsoft Office and job-related computer applications required.
  • Report, standards, policy writing skills required.
  • Understanding of Lean Six Sigma Methodology preferred.
  • Understand the specific responsibilities of all Carlow departments as they relate to one’s own department, understanding the business processes one’s 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.
  • Data analysis.
  • Training skills.

 

 

 

2020-311 - Analytical Sciences Team Lead - Waterford City

Purpose:

Reporting to the Analytical Sciences Manager, you will be responsible for leading a team of Analytical Sciences analysts and play an integral role within the AS team for project delivery. You will have responsibilities as a technical and product expert and will work with the analytical scientists, senior scientists, team leaders, our customers and partners in delivering projects in a safe manner and within agreed timelines. Analytical Sciences are responsible for the analytical transfer, validation and lifecycle management of methods to enable the site to bring in new business. The department is the first to source and implement new analytical technologies for the site. Analytical Sciences are the subject matter experts for all analytical testing within the Waterford site and the team lead will play an integral part in delivering the product and program roadmap.

Responsibilities:

  • Lead, mentor and support a team of Analytical Sciences Analysts in the delivery of analytical method transfers, validations and ALCM activities.
  • Develop analytical expertise within the AS department.
  • Oversee the day to day running of the Laboratories and managing the workload of the team.
  • Lead troubleshooting activities to ensure timely resolution of issues.
  • Review technical documentation, primarily Transfer and Validation Protocols, Summary Reports, Risk Assessment documents and other Technology Transfer supporting documents, as requested or instructed, for content and quality of the document to be fit for purpose.
  • Effective interaction with other departments and project teams.
  • Ensure compliance to the Quality Management System is maintained and its effectiveness monitored.
  • Assists in producing established metrics to monitor department activities and performance measures.
  • Ensures projects are managed in conjunction with all required company and regulatory requirements (EHS, cGLP, method transfers, environmental etc.)

 

 

Minimum Qualifications and Experience:

  • 3rd level qualification in engineering or science, MSc or PhD preferred.
  • Minimum of 7 years’ experience in the pharmaceutical or biotechnology industry required.
  • Demonstrated performance in leading teams and project delivery.
  • Strong focus on quality and proven attention to detail and accuracy.
  • Excellent analytical ability, experience with Empower software preferred.
  • Operational experience of quality laboratories in a fast-moving manufacturing environment.
  • Excellent communication and organisation.
  • Fluent English, both written and oral – essential.
  • Problem solving skills for developing creative solutions and meeting objectives are required.
  • Able to manage projects to plan/budget.
  • Proven track record of prioritising tasks and managing several projects simultaneously.
  • Experience with mentoring team members.
  • Strong safety, quality and continuous improvement focus.
  • May be required to deputise for Analytical Sciences Manager.
  • You will have excellent communication skills (interpersonal, presentation, and writing) and will be able to effectively communicate both technical and non-technical information.
  • You will be a highly motivated and self-driven leader of people.

 

 

 

10357 - Process Engineer - Cork

Purpose:

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

Responsibilities:

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

 

 

Minimum Qualifications and Experience:

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

 

 

 

2019-235 - Senior Financial Reporting Manager - Waterford City

Purpose:

As Statutory Reporting Manager, the person will be responsible for key financial processes within the organisation. The person will be responsible for a number of legal entities with the emphasis on ensuring that all statutory and tax reporting requirements are achieved and that systems and processes are maintained and enhanced to ensure reporting requirements, both local and internationally, can be delivered in an efficient manner. In addition, the person will have responsibility within the monthly close process, ensuring timely and accurate submissions to Head office and ensuring key SOX controls are maintained. As a senior member of staff the person will also liaise with Corporate Head office, presenting and explaining results. To this end the individual will need to gain very quickly an understanding of the business and how it operates and build key relationships within the Corporate organisation. The person appointed will need to have initiative and drive to work in a fast paced, ever changing environment. Excellent communication skills and an ability to work well within a small team are essential.

Responsibilities:

  • Full responsibility for all legal entity reporting;
    • Annual Statutory financial statements.
    • Interim Statutory Financial Statements.
    • Annual Statutory Audit.
    • Creating processes to ensure financial statements can be delivered efficiently.
    • Interpreting legal documentation and accounting appropriately.
    • All CSO and other statutory reporting requirements.
    • SOX compliance for relevant areas.
  • Tax Compliance Reporting for all legal entities;
    • Tax provisioning – current & deferred tax.
    • Annual tax submissions and queries.
    • Tax reporting to Corporate Tax Group.
    • Tax planning with Corporate Tax Group.
  • Other key responsibilities;
    • Management Fee accounting & reporting.
    • FX analysis for legal entity.
    • Preparation of presentations for board meetings.
    • Responsibility for Government support initiatives.
    • Managing grant agreements from inception to close.
    • Grant applications.
    • Grant claims.
    • R&D Tax credits.

 

 

Minimum Qualifications and Experience:

  • Qualified Accountant with 8+ years post qualification experience.
  • Experience in accounting for complicated financial structures.
  • Good working knowledge of accounting software packages required – Peoplesoft, SAP, HFM.
  • Advanced Excel skills.

 

 

 

10412 - Project Coordinator - Cork

Purpose:

Project Co-Ordinator will provide project scheduling and execution support in manufacturing quality pharmaceutical products. The team working style is one of collaboration, coaching and facilitating to provide solutions to the team to support a High-Performance Organization. This individual will be a part of a newly formed Project Management Office (PMO), to ensure that the site delivers on 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 programs 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 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.
  • 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.
  • 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.
  • 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.
  • Delivery of effective & accurate project progress reports that can be analysed and understood at all levels within the organization.
  • 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.

 

 

9733980 - Cleaning Validation Lead - Athlone

Purpose:

The Cleaning Validation Lead will govern all activities to support cleaning validation activities in the company’s cGMP commercial and clinical Biologics and fill finish manufacturing. The responsibilities of the incumbent will primarily include performing cleaning and filter validation as well as supporting the technical services department in Technical Transfers.

Responsibilities:

  • Lead cleaning validation/verification activities to ensure cGMP requirements are met.
  • Manage the multiproduct cleaning validation approach for new product introductions.
  • Manage and deliver specific cleaning and process validation projects according to business priorities and regulatory requirements.
  • Review and approve process validation documentation to ensure it meets internal and regulatory requirements.
  • Develop process validation plans, protocols and reports and co-ordinate and manage their execution.
  • Oversee all responsibilities and perform additional tasks assigned by the departmental manager.
  • Carry out all duties in accordance with Development and Production Safety and Quality policies.
  • Participate and contribute in the design and development of automation, equipment and process/cleaning validation strategy.
  • Provide technical input to strategy/philosophy for validation of equipment and automation changes associated with cleaning processes.
  • Filter Validation lead on site.
  • Responsible for developing and executing commissioning and qualification documentation for new or modified process systems and equipment. This may include the development of user and function requirements, execution of factory/site acceptance testing, commissioning, and development of design qualifications.
  • Support the execution of validation studies specific to filter validation, process simulations and process validation.
  • Support and execution the requalification program.
  • Support department to be audit/inspection ready and participate in audits and regulatory inspections as required.
  • Serves as company point of contact for cleaning validation studies performed by external contractors or vendors, coordinating execution of studies with company’s Manufacturing Operations, Engineering, Utilities and QA personnel as required.
  • Support continuous improvement of company’s facilities and equipment by risk assessing proposed changes to ensure the qualified state is maintained. Generate and execute approved change control test scripts to demonstrate that proposed changes are appropriate and do not impact cleaning and process validation.
  • Proactively take action to consistently improve personal knowledge and capability. Demonstrate an awareness of own capabilities and development needs. Demonstrate a proactive approach to gaining new knowledge, skills and attributes.
  • May be required to perform other duties as assigned.

 

 

Minimum Qualifications and Experience:

  • Bachelors Degree in engineering or scientific discipline preferred. Associate’s degree or certificate in biotechnology (minimum) required.
  • Five years’ experience in a cGMP biopharmaceutical or Biologics/aseptic filling environment is preferred but not required.
  • Direct experience performing validation studies in cGMP biopharmaceutical or aseptic filling/Biologics environment is required.
  • Cleaning validation and filter validation experience.
  • Knowledge of Biologics, aseptic processing and liquid filling operations preferred.
  • Good interpersonal skills are required, as is the ability to communicate well, both verbally and written. Must be able to function effectively in a teamwork environment.
  • The individual in this position is expected to represent company interests, objectives and policies in a professional and responsible manner.

 

 

9815475 - QA Validation Specialist - Dublin

Purpose:

Responsible for delivery of quality assurance activities at the company’s Dublin Bulk Drug Substance 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 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, 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.

 

 

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.
  • Knowledge of automation and IT systems a distinct advantage.

 

9732209 – Quality Assurance Specialist – Dublin

Responsibilities:

  • Execute 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.
  • Ensure effective interaction with other departments and locations regarding GMP Document review and finished product releases.
  • Partnering with major stakeholders such as Manufacturing, Validation, Engineering to optimize patient supply.

 

Minimum Qualifications and Experience:

  • Third level qualification e.g. B.Sc. in science/pharmacy.
  • Minimum of 3 years’ experience in cGMP Quality environment; or equivalent combination of education and experience.
  • Strong knowledge of cGMP requirements for biopharmaceutical and/or sterile manufacturing.
  • Experience performing review and approval of validation studies in cGMP biopharmaceutical is an advantage.
  • Planning and organizing skills are required to plan and to adjust to changing priorities.
  • High level technical skills including analytical, auditing, pharmaceutical manufacturing and regulatory inspection management.
  • Excellent interpersonal skills are required, as is the ability to communicate well, both verbally and written.
  • Management experience is an advantage.

 

10437 - Training Manager - Dublin

Purpose:

The Learning Specialist will help define, develop, and facilitate all learning and development plans and activities for QC group(s) within the site in support of the site’s learning strategy and Annual Learning Plan. This individual will partner with QC and learning and development 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. The Learning Specialist will report to the QC Lead.

Responsibilities:

  • Establishes relationships with and partners with client group(s) to understand the business goals/objectives and collaboratively defines appropriate learning strategies for client area.
  • Conducts learning needs assessments and/or job analyses with client to identify relevant learning plans and solutions.
  • With the business, implements learning strategy/plans (inclusive of job and functional skills) for business client. Monitors progress with appropriate documentation and metrics and defines opportunities for continuous improvement.
  • Implements standard learning processes for client group; ensures ongoing adherence through coaching and appropriate use of metrics.
  • Works collaboratively within the Learning organization to implement, maintain and continuously improve standard site learning processes (i.e. Job Skills Qualification, SOP Process, Annual GMP, Safety Programs and New Employee Onboarding.)
  • Ensures client is in Permanent Inspection Readiness and cGMP Compliance as it relates to Training/Learning & Development.
  • 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.
  • Minimum of 5 years of pharmaceutical manufacturing experience.
  • QC experience a strong advantage.
  • Experience in building curricula’s.
  • Expert level in Learning Management Systems (LMS.)
  • Strong in communication and using visualisation tools.
  • Working knowledge and application of Instructional Design, Adult Learning Principles, and Evaluation Methodologies.
  • Working Across Boundaries: Demonstrates an understanding of how one’s job responsibilities contribute to the department’s goals and a knowledge of the business’s core strategy for long-term success.
  • Fosters Interpersonal Relationships & Collaboration: Actively listens and seeks to understand differing perspectives; work together to achieve the common goals of the company. Demonstrated skill in applying approaches, tools, and techniques for working with individuals and groups in a constructive and collaborative manner, including the ability to build and maintain critical networks and collaborative relationships.
  • Productive Communications (Oral & Written): Ability to distribute accurate information and craft messages for appropriate target audiences, with guidance if needed. Speaks and writes clearly and concisely with the ability to select the appropriate form of communication to share information.

 

10343 - QC Analyst - Carlow

Purpose:

A fantastic QC Analytical opportunity for candidates interested in a new challenge in a cGMP regulatory environment. We have built a new state of the art Quality Operations laboratory, we are looking for QC Analysts who will report directly to the QC Chemistry Manager and who will help us in the start-up of this laboratory, complete Analytical method transfers and testing. The ideal candidate will have 2- 3 years’ experience in a pharmaceutical laboratory, ideally with experience in HPLC and relevant systems and software. Core to the role is to perform testing of samples to support the release of our key drug products. The candidate will contribute to the positive culture by providing an inclusive environment to enable team members to achieve their best work.

Responsibilities:

  • Work as directed by the Quality Control Manager according to Company safety policies, cGMP and cGLP. Required to drive compliance with company Global policies, procedures and guidelines and regulatory requirements and execute Good Manufacturing Practices (cGMP) in the performance of day to day activities and all applicable job functions.
  • Participate in QC Tier 1 daily meetings and ensure effective communication of testing progress, deviations etc.
  • Participate in writing/revising/ rolling out accurate operational procedures, training materials and maintenance procedures for various Quality systems; ensure all work is carried out in line with same.
  • Operate as part of the QC team performing the allocated testing and laboratory based duties.
  • Perform various analytical techniques including but not limited to HPLC, (HIC, CE, IEX, HP-SEC), Capillary Electrophoresis and other compendial test methods in compliance with GMP requirements.
  • Peer review testing documentation and ensuring data integrity compliance and QC Right First Time KPIs are achieved.
  • Participate in the laboratory aspects of OOS investigations.
  • Provide support with audit/inspection requirements to ensure department compliance/readiness.
  • Participate in internal and external audits and inspections, taking the role of auditee for assigned areas of responsibility.
  • Drive continuous improvement, perform root cause analysis on system failures and substandard equipment performance, using standard tools and methods, to resolve machine and system issues e.g. FMEA, Fishbone diagrams, 5 why’s etc.
  • Work collaboratively to drive a safe and compliant culture in Carlow.

 

Minimum Qualifications and Experience:

  • Bachelors Degree or higher preferred; ideally in Analytical Chemistry/ Biochemistry or a closely related discipline.
  • 2-3 years of experience in a pharmaceutical laboratory.
  • A good working knowledge of HPLC systems and software is desirable.
  • A good knowledge of cGMP, GLP, Quality Management Systems.
  • Occasional travel may be required.

 

10435 - Automation Engineer - Carlow

Purpose:

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

Responsibilities:

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

 

Minimum Qualifications and Experience:

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

 

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.

 

10423 - Health and Safety Specialist - Cork

Purpose:

Reporting to the Utilities Lead, the purpose of this role is to be a Process Engineer supporting the Waste Water Treatment Plant (WWTP). This is a key role to ensure that the day to day operations of the Utilities are provided to the WWTP to ensure compliance. This role provides operational, quality, utility, environmental, safety and waste water treatment services and expertise to WWTP to enable the manufacture of quality pharmaceutical products in accordance to meeting the company’s Manufacturing Division Priorities of: Compliance, Supply, Strategy and Profit Plan.

Responsibilities:

  • Ensure highest Compliance (Safety and Environmental) standards with site IED License, Corporate policies, global standards, and procedures for WWTP.
  • Management of day to day operations of WWTP operations.
  • Ensure WWTP equipment availability, maximise performance of WWTP operations and identify / implement continuous process improvement initiatives.
  • Streamline and optimize WWTP plant processes.
  • Be an active participant within the Utilities Engineering team sharing Engineering best practices.
  • Promote a culture of EHS excellence and provides high-quality safety, health and environmental technical leadership to assigned projects.
  • Attending daily Tier meetings and follow-up.
  • Assists in the management the site’s periodic EHS Self Assessments programme to assure conformance with Site, Corporate and/or Statutory EHS requirements.
  • Responsible for investigating EHS Incidents related to the WWTP.
  • Attending and responding to relevant Hazop studies and completion and follow-up of specific risk assessments.
  • Responsible for representing WWTP for both internal and external audit inspections.
  • Delegates for Utilities Lead as required.
  • Provide environmental and EHS support for projects.
  • Operate in full compliance with site, industry and EPA requirements in waste water treatment and disposal.
  • Participate in efficiency and streamlining projects which contribute to site initiatives and contribute to increased safety, process improvement cost saving etc.
  • Responsible for supporting a culture of Continuous Improvement by deploying company Six Sigma tools such as Lean principles within the WWTP area.
  • Model the company Leadership behaviours and understand the MPS principles to drive a culture of continuous improvement building a High Performance Organisation.

 

Minimum Qualifications and Experience:

  • Degree or 3rd Level Qualification (Process/ Mechanical Engineering or EHS Environmental), Desirable Masters qualification (specifically environmental.)
  • >3 years’ experience operational experience in WWTP plant environment with experience in the utility management, Waste water treatment, safety and environmental compliance.
  • WWTP process and technology background: the successful candidate will understand how to drive optimization.
  • Demonstrated ability to realize improvement initiatives.
  • Demonstrated successes in a team environment, such as project teams, Six Sigma team, etc.
  • Demonstrated high level of problem solving, innovation and facilitation skills.
  • Advanced PC skills such as Excel, Word, PowerPoint.
  • Experience with Management Systems such as SAP, EHS, Microsoft PM, etc.
  • High level of knowledge of Safety, Quality and Environmental requirements.
  • Excellent verbal and written communication skills (includes ability to write standard operating procedures and work protocols.)
  • Ability to plan, prioritise and effectively manage time, meet deadlines and produce quality deliverables.
  • Demonstrated experience of stakeholder management of multiple decision makers, cross functional teams.
  • Desirable Lean Six Sigma Green Belt Qualification.
  • Results and performance driven.
  • Adaptive and flexible.

 

10406 - Compliance Specialist - Cork

Purpose:

Reporting to the Utilities Lead, the purpose of this role is to be a Process Engineer supporting the Waste Water Treatment Plant (WWTP). This is a key role to ensure that the day to day operations of the Utilities are provided to the WWTP to ensure compliance. This role provides operational, quality, utility, environmental, safety and waste water treatment services and expertise to WWTP to enable the manufacture of quality pharmaceutical products in accordance to meeting the company Manufacturing Division Priorities of: Compliance, Supply, Strategy and Profit Plan.

Responsibilities:

  • Ensure highest Compliance (Safety and Environmental) standards with site IED License, Corporate policies, global standards, and procedures for WWTP.
  • Management of day to day operations of WWTP operations.
  • Ensure WWTP equipment availability, maximise performance of WWTP operations and identify / implement continuous process improvement initiatives.
  • Streamline and optimize WWTP plant processes.
  • Be an active participant within the Utilities Engineering team sharing Engineering best practices.
  • Promote a culture of EHS excellence and provides high-quality safety, health and environmental technical leadership to assigned projects.
  • Attending daily Tier meetings and follow-up.
  • Assists in the management the site’s periodic EHS Self Assessments programme to assure conformance with Site, Corporate and/or Statutory EHS requirements.
  • Responsible for investigating EHS Incidents related to the WWTP.
  • Attending and responding to relevant Hazop studies and completion and follow-up of specific risk assessments.
  • Responsible for representing WWTP for both internal and external audit inspections.
  • Delegates for Utilities Lead as required.
  • Provide environmental and EHS support for projects.
  • Operate in full compliance with site, industry and EPA requirements in waste water treatment and disposal.
  • Participate in efficiency and streamlining projects which contribute to site initiatives and contribute to increased safety, process improvement cost saving etc.

 

Minimum Qualifications and Experience:

  • Degree or 3rd Level Qualification (Process/ Mechanical Engineering or EHS Environmental), Desirable Masters qualification (specifically environmental.)
  • >3 years’ experience operational experience in WWTP plant environment with experience in the utility management, Waste water treatment, safety and environmental compliance.
  • WWTP process and technology background: the successful candidate will understand how to drive optimization.
  • Demonstrated ability to realize improvement initiatives.
  • Demonstrated successes in a team environment, such as project teams, Six Sigma team, etc.
  • Demonstrated high level of problem solving, innovation and facilitation skills.
  • Advanced PC skills such as Excel, Word, PowerPoint.
  • Experience with Management Systems such as SAP, EHS, Microsoft PM, etc.
  • High level of knowledge of Safety, Quality and Environmental requirements.
  • Excellent verbal and written communication skills (includes ability to write standard operating procedures and work protocols.)
  • Ability to plan, prioritise and effectively manage time, meet deadlines and produce quality deliverables.
  • Demonstrated experience of stakeholder management of multiple decision makers, cross functional teams.
  • Desirable Lean Six Sigma Green Belt Qualification.
  • Results and performance driven.
  • Adaptive and flexible.

 

10145 - Supply Chain Specialist - Tipperary

Responsibilities:

  • Co-ordination of Customer Order Process from Forecast through Order receipt, acknowledgement and shipment.
  • Review demand forecast and reconcile with customer orders received.
  • Communicate customer special requirements to IPTs/CoEs to ensure timely delivery.
  • Where inventory issues or special requirements exist, coordinate order acceptance with IPT Planners and Hub planners.
  • Maintain customer service information document.
  • Receive, review and promise all sales orders
  • Handle request to change orders e.g. ship dates, quantity etc.
  • Ensure credit limits are in place and will not be exceeded for relevant customers prior to accepting order.
  • Assign API & Bulk product lots to individual customer orders in accordance customer requirements, GMP regulatory requirements and customer country pharmacopoeia requirements. HR BTE 18 Form 1 SCM SALES ORDER ACCEPTANCE & LOGISTICS IE0113 Page 2 of 3 HR BTE 18 JOB DESCRIPTIONS Rev 7.0
  • Adjust shipping arrangements, as necessary, to minimize customer impact in the event of delayed release due to validations / process deviations / OOS’s.
  • Develop /agree basis with Financial Services for all sales price adjustments & then execute.
  • Be first point of contact for customer queries / complaints.
  • Maintains ongoing accurate dialogue with customers and Hubs regarding order status and requested ship dates.
  • Generate management reports on the customer service operation as required.
  • Coordinate response to requests for legalization of quality or trade documentation.
  • On weekly basis, develop and publish Sales Order Look ahead (SOLA) to Warehouse and freight forwarding companies.
  • Generate shipping documentation including Invoice, Packing List, import/export issues, Bills of Lading, Airway Bills, Hazard documentation and certification, labelling, Customs & Excise documentation, insurance, letters of credit and any additional documentation associated with product shipments in accordance with commercial/technical and GMP regulations.
  • Approve all shipping documents.
  • Coordinate orders collections with freight forwarders and arranging collections in line with insurance limitations, to maximise value to the company.
  • Track critical/special API & Bulk product shipment to delivery at the customer site.
  • Ensure that all commercial / regulatory requirements are adhered to.
  • Respond to Revenue requests for trade value information.
  • Develop & maintain metrics on Customer Service, Sales Order Process and freight forwarder performance as required.
  • Back-up to Logistics Co-Coordinator role as required.
  • Carry out Sales Order Process, Labelling & Packaging, Departmental Procedures training for materials management and plant personnel, as required.
  • Completion of Intrastat & VIES reports for exports & imports.
  • Maintain Label & Packaging Specifications and facilitate the introduction of new label to site.
  • Trade compliance back up : Maintain compliance on all customs related to import/export queries, clearances.
  • Back up process steward for OTC.
  • Complete all SAP transaction on Customer returns process.
  • Re-Issue of CoA’s.
  • Investigate and respond to customer complaints for logistics issues.
  • Returns to Vendor.
  • Usage of transport management system (TMS) for all export shipments.

 

Minimum Qualifications and Experience:

  • Compliance Training in the following preferable, and SAP Training:
    • DGSA/IATA/IMO Safety regulations.
    • GMP Policies and procedures.
    • Financial Procedures and Controls Rules of Origin, INCO Terms etc.

 

2020-310 - Value Stream Manager - Waterford City

Purpose:

We are currently looking for a Value Stream Manager who will manage all Site manufacturing resources and operations within their shift regulated Value Stream (Weekend Position.)

Responsibilities:

  • Create a highly talented Value Stream Team (VST) and champion a positive employee environment by promoting a culture of open communication, engagement and development of team members.
  • Agree and drive operational excellence by setting clear direction and expectations for performance. Establish performance targets for the Value Stream, and measure actual performance with regard to Product Quality, Customer Service, Employee Engagement, Production efficiency and Cost. Take appropriate and timely corrective action if negative trends begin to emerge.
  • Provide leadership direction to the VST on process improvements, address obstacles, provide resources and interact with other areas of the company to assist team in overcoming problems and streamlining the work process as part of a structured continuous improvement program.
  • Promote & Engage Lean Manufacturing & Visual Management concepts within the Value Stream and continuously improve the performance of the team.
  • Report on VST Performance at Monthly Business Review, covering all aspects of Performance, for example, achievement of production goals (OEE), key quality and EHS metrics, cost reduction efforts, process improvements, employee engagement and other topics of critical interest.
  • Promote Quality and Customer Service as an integral way of working.
  • Maintain & improve health & safety systems and practices. Promote an EH&S compliant culture.
  • Ensure awareness and achievement of all regulatory and compliance requirements (FDA, ISO, EH&S, etc.)

 

Minimum Qualifications and Experience:

  • Degree in Business or Engineering or equivalent desirable.
  • Strong Operational Leadership experience in a manufacturing environment required (Medical Device/Pharma background desirable but not essential.)
  • Strong Technical competence and comprehensive understanding of manufacturing technologies in a high volume, regulated environment.
  • Clearly understands and has experience of the Principles and structure of real Business Excellence and functional integration, a broader focus than just Lean and tools approach.

 

10094 - QC Specialist - Dublin

Purpose:

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

Responsibilities:

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

 

Minimum Qualifications and Experience:

  • BSc. (or equivalent experience base) in analytical chemistry, pharmaceutical science or a related discipline.
  • The Quality System.
  • Plant procedures and policies.
  • Company procedures, policies and guidelines.
  • Plant documentation.
  • Laboratory testing and documentation.
  • Validation principles and guidelines.
  • Computer skills.
  • System Development Life Cycle.
  • Project management.
  • Communication skills both written and oral.
  • Team and interpersonal skills.
  • Technical report writing.
  • Time Management.
  • Meetings Management.
  • Analytical Problem-solving skills.
  • Planning and Scheduling.
  • Continuous improvement skills.

 

10354 - Project Manager IT - Carlow

Purpose:

Reporting to the Carlow Automation and IT (AIT) Technical Lead, specifically responsible for the ‘Digitisation’ workstream (1 of 7 workstreams within the AIT program.) This candidate will be required to work closely with the Carlow AIT teams responsible for the full Automation and IT scope and with vendors / partners with responsibility for delivery of systems. This role is responsible for the specification and design of capabilities to support the widespread adoption of Process and Business Analytics within the site.

Responsibilities:

  • Responsible for the specification and implementation of a range of IT solutions that will enable the incorporation of best practice data analytics into all aspects of facility operations.
  • Works closely with site operations colleagues to define and develop standard process and business dashboards (and other reporting solutions.)
  • Develops and implements appropriate data governance and change management around the solutions.
  • Works closely with the AIT Scheduler/Planner to develop a robust delivery schedule and ensure this schedule is aligned with project delivery commitments to site.
  • Manages progress in line with the schedule; reports progress, issues and risks in line with AIT project reporting requirements and timetable.
  • Works closely with the teams working in the same space to ensure process & technology alignment.
  • Responsible for providing ongoing support for solutions as they are implemented.
  • Works closely with the Enterprise Big Data Platform and Data Science teams and Global Infrastructure organisations to ensure that the site is implementing best in class analytics solutions, and that those solutions receive appropriate ongoing support.
  • This role will drive the adoption of data and visualization solutions by the site IT and automation team.
  • This role will provide leadership in the use of analytics and visualization solutions in the manufacturing space and will identify solutions that can be rapidly propogated across the enterprise. As part of that, this role will have responsibility for the implementation of a number of pilots around the use of innovative new technologies in the area of Data Analytics and visualization.
  • Responsible for regular communication to project leadership & multi-functional team stakeholders.
  • Assures all design & project work is completed in compliance with all Regulatory requirements including, Quality (cGLP/GMP’s), EHS, Global Engineering, design & construction directives, requirements & procedures, as well as all Local/Federal Regulatory requirements.

 

Minimum Qualifications and Experience:

  • Bachelor’s Degree in a relevant discipline is required. Master’s Degree preferred.
  • 3+ years experience in the implementation and support of Data Analytics and Visualisation tools.
  • Decision making and problem-solving skills.
  • Experience with the implementation of the following tools in an Enterprise environment;  Hadoop
    • Spotfire
    • Tableau, R , Spark
    • OSI PI
  • Experience and interest in recent developments in Data Analytics and Big Data applications in Manufacturing such as Industry 4. 0 or Industry Internet of Things (IIoT) is highly desired.
  • Background in biopharmaceutical processes preferred.
  • Ability to work with all levels of business customers in a highly dynamic environment.
  • Location for this role will be Carlow. The candidate must be willing to travel (occasionally) to other company sites, travel to off-site meetings in vendors premises and attend meetings in off-site locations as required by the project.

 

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.

 

9801515 - EHS Senior Specialist - Dublin

Purpose:

The Senior Specialist, Environmental Health and Safety will provide environmental, health, and safety support for all operations at the Manufacturing Facility.

Responsibilities:

  • Develops implements and monitors environmental, health & safety programs to ensure compliance with all applicable government regulations and company standards and values.
  • Works closely with manufacturing staff operations and the EHS Team to promote safe manufacturing practices, procedures, and proper use of containment equipment and facilities.
  • Identifies and addresses site EHS issues and employee concerns.
  • Performs incident management activities including injury management investigations and associated recordkeeping.
  • Identifies implements and tracks corrective actions to prevent recurrence.
  • Performs EHS hazard assessments including industrial hygiene monitoring and makes recommendations to control hazards.
  • Manages governance of life safety fire and property risk management programs.
  • Develops, implements and maintains training programs for health, safety and the environment.
  • Responsible for developing appropriate emergency plans and response capabilities.
  • Maintains availability to respond to emergencies during off-hours (evenings, weekends, holidays.)
  • Stays abreast of new EHS government regulations as they are promulgated as well as new developments in industry (best practices.)
  • Builds relationships with key departments to foster support for EHS programs.
  • Serves as the site Biosafety Officer.
  • Managing the Waste Management Contractor to ensure compliance and efficient disposal methods.
  • Maintains compliance with Environmental Licenses and Permits.
  • Develops and maintains the Environmental and Health & Safety Management System.

 

Minimum Qualifications and Experience:

  • BS in an EHS-related discipline, such as engineering, physical science, or biological science/chemistry, or equivalent experience required.
  • Qualification or experience in safety and environmental required.
  • A minimum of five years’ professional experience required in environment, health, and safety programs.
  • A minimum of 2-4 years relevant experience in cGMP environment is desirable.
  • Knowledge and understanding of environment, health, and safety permitting and regulations.
  • Knowledge and understanding of environment, health, and safety compliance reporting.
  • Specific experience in hazardous waste management or other professional EHS trainings or certifications a plus.
  • Experience in Integrated Pollution Prevention & Control (IPPC) or Industrial Emissions (IE) Licensing, GMM (Genetically Modified Microorganism) Consent and/or Emissions Trading required.
  • Ability to make effective oral presentations and work as part of a team.
  • Proficiency in organizing, communication, problem solving, multitasking and collaborating with others.
  • Ability to develop and roll out EHS programs as required by the operational needs of the business.
  • The individual in this position will be able to organize their own work on a routine basis and requires minimal supervision. The individual must be able to provide updates and tracking on tasks.
  • Good communication skills required, both verbal and written.

 

9776329 - QC Micro Analyst - Dublin

Purpose:

The QC Microbiology Analyst will support the Bulk Drug Facility in Dublin with emphasis on microbiological testing such as Environmental Monitoring, Water, Gas and raw materials sampling and testing, Bioburden and Endotoxin, technical support with regard to method validation, regulatory updates and new technology. This position will work on a shift schedule.

Responsibilities:

  • Environmental and Facilities monitoring sampling and testing.
  • Ensuring high cGMP, GLP standards are maintained while testing and adherence to schedules and targets to meet regulatory and business requirements.
  • Validation/Qualification of Microbiology test methods and test systems such as the Endotoxin test system and Identification system.
  • Represent the Microbiology department in internal and external audits where appropriate.
  • Close out of actions/ recommendations identified from both internal and external audits.
  • Assist in ensuring that current compliance issues and trends, both internal and site-wide, are critically evaluated and training is provided where appropriate.
  • To maintain competence and keep up to date with all new technologies, procedures and methods used in the Microbiology Laboratory.
  • Perform technical review of data generated in laboratory, validation protocols and reports.
  • Provide Technical support to Manufacturing and Projects which the company undertakes through project participation, investigation, validation and testing activities and prepare Technical Reports as required.
  • To ensure all instruments/equipment are maintained in a calibrated and operational state.
  • To ensure a high standard of housekeeping and safety is maintained in the Laboratory.
  • Completion of project work and implementation of initiatives designed to improve the efficiency of the laboratory function/department.
  • To keep management updated on issues arising within the laboratory.
  • Scheduling of testing, review and authorization of microbial data.
  • Investigate out of specification/limit results utilizing Structured Problem Solving, Root Cause Analysis tools in conjunction with the Microbiology Laboratory Supervisor, QA and other relevant departments and to implement effective corrective and preventative actions while ensuring all investigations are closed with the specified lead-time.
  • To train laboratory personnel and play appropriate role in the development, operation and evaluation of training/re-training programs.
  • Any other duties as required by management.

 

Minimum Qualifications and Experience:

  • Degree in Microbiology or related science.
  • Minimum of 1 year experience in cGMP Quality environment.
  • Experience in testing of sterile drug product and aseptic filling process of sterile pharmaceutical /biopharmaceutical products.
  • Good knowledge of current regulatory requirements for Microbiology / Sterility Assurance in support of cGMP operations supporting clinical and commercial manufacturing.
  • Technical competency in Sterility Assurance, Aseptic filling and microbiology methods.
  • Ability to develop collaborative relationships with other functions and sites in order to achieve functional, site and company goals.
  • Problem solving and root cause analysis skills.
  • Organizational skills.
  • Planning/scheduling of own work and subordinates and ability to delegate tasks where appropriate.
  • Excellent written and oral communication skills.

 

9767140 - Packaging Operations Associate - Dublin

Responsibilities:

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

 

Minimum Qualifications and Experience:

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

 

2020-309 - Quality Assurance Team Lead - Waterford City

Purpose:

To support the Head of Quality and Quality Assurance Manager with the development, implementation and maintenance of company quality standards and systems to ensure that products comply with Marketing Authorisations, documentation, specifications and cGMPs. To lead and develop the company’s group of Quality Assurance Officers. To ensure project plans and milestones are delivered according to agreed timelines.

Responsibilities:

  • Project Planning / Co-ordination:
    • Together with the Quality Assurance Manager, actively plan Quality Assurance functions requirements; ensuring major milestone targets for each project are visible to all team members and key stakeholders to achieve on time market entry.
    • Together with the Quality Assurance Manager, determine tasks and resources required to deliver each project milestone and deliverables.
  • Compliance:
    • To ensure that all work carried out is in compliance with the required standards conforming to company, cGxP, SOPs, regulatory regulations and guidelines, safety and environmental guidelines.
    • Ensure high quality output – Vigilantly watch over job processes, tasks and work products to ensure freedom from errors, omissions or defects.
    • Initiate action to correct quality problem and notify others of quality issues as appropriate. If a procedure does not exist, devise one, (through the appropriate channels); if a process needs amending, do so through the appropriate channels.
  • Continuous Improvement:
    • To identify and make recommendations for improvements as part of a team within or outside the department in order to ensure continuous improvement. Highlight opportunities for system optimisation to team members.
  • Documentation:
    • To ensure review of all QC and production batch documentation when required and correctly in order to achieve a high level of customer service and cGMP.
    • To ensure preparation of Submission Documentation in support of license applications.
  • Leadership:
    • 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.
  • Product Reviews:
    • Ensure that Product Reviews are scheduled and that the schedule is maintained and adhered to.
  • Technical Agreements:
    • Ensure that customer/ Contract services Technical Agreements are initiated and maintained.
  • SAP:
    • Ensure that SAP material changes are reviewed for correct updates and ensure SAP QA metrics generated monthly.
  • Customer requests:
    • Ensure that all customer requests are dealt with within a reasonable timeframe and are extensive.
  • Commercial Manufacture:
    • Ensure Commercial Meetings are attended and related trackers are maintained and timelines are agreed and achieved.
  • QMS Meetings:
    • Ensure that Quality Management System meeting schedule is established and maintained and that QA are present to facilitate these meetings.
  • QA/ QP release:
    • Ensure that the Batch documentation, Laboratory results and related Quality Systems are correct and approved prior to any QA/QP release required.
  • Self Inspection Program:
    • Ensure Self Inspection Program is maintained.
  • Inspections:
    • Manage and Lead/ Participate in outside Inspections (Customer audits / Regulatory inspections.)
  • Safety:
    • Ensure requirements of the company Safety Statement are implemented and promote a positive safety culture by leading by example.
  • To perform additional team tasks as agreed to support effective running of the Business.

 

Minimum Qualifications and Experience:

  • Qualified to a minimum of degree level, preferably a Science degree incorporating Quality Assurance.
  • 5 years’ experience working in a Quality Assurance role in a manufacturing environment with a minimum of 2 years in a team lead/supervisory role.
  • Lead Auditor qualification complete.
  • Supervisory Management qualification an advantage.
  • Experience in managing a team of direct reports required.
  • Familiarity with cGMPs relating to pharmaceutical manufacturing.
  • Computer Skills to include MS office.
  • Working knowledge of EDMS (Electronic Document Management System) and ERP (Enterprise Resource Planning.)
  • Safety Awareness.
  • Compliance & adherence to regulations.

 

2020-308 - Senior Quality Assurance Officer - Waterford City

Purpose:

To support the Quality Assurance Manager with the development, implementation and maintenance of the quality standards and systems to ensure that products comply with Marketing Authorisations, documentation, specifications and cGMPs.

Responsibilities:

  • To support the Quality Assurance Manager and Quality Assurance Team lead with the quality assurance function for OSD Commercial and R&D products.
  • To ensure that all work carried out in is in compliance with the required standards conforming to company, cGxP, SOPs, regulatory regulations and guidelines, safety and environmental guidelines.
  • Implement and maintain the company’s Vendor Qualification Programme, ensuring robust Quality agreements and adequate CMO Oversight is in place.
  • Review batch related documentation as required and ensure OTTR Targets are met.
  • Ensure company internal (self-inspections) and external QA audits are complete as per the effective schedules.
  • Noncompliance reporting and corrective action / continuous improvement implementation.
  • QA Representative for NPI and Product development projects.
  • Support the on-going OOS/OOT/ Deviation/CAPA closeout programme, ensure records are compliant and closed on time.
  • To support major /critical change implementation across the site for all processes.
  • 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 customer/ regulatory inspections.
  • Attend a number of cross functional team meetings as a Quality Assurance representative to assist in running the business.
  • To perform additional team tasks as agreed to support effective running of the Business.
  • Compile and deliver quality based training within the Quality Team.
  • Liaise with operations / laboratory personnel to ensure regulatory and quality requirements are met.
  • Assist with preparation of Submission Documentation in support of license applications and/or deficiency responses.
  • Health & Safety:
    • Implement safety requirements as per site documentation including SOPs, Safety Statement and COPs.
    • Report any Hazards.

 

Minimum Qualifications and Experience:

  • A third level degree incorporating Quality Assurance/ management.
  • A minimum 5 years Quality Assurance experience in the role in a pharmaceutical manufacturing environment.
  • Significant experience with desktop and internet-based software applications (e.g. electronic document management system, Trackwise etc.)
  • Lead auditor training complete.
  • Internal audit experience.
  • Experience with facilitating customer audits.
  • Excellent communication and presentation skills.
  • Focus on quality and detail.
  • Careful planning to achieve accurate and timely results.
  • Ability to define and manage own tasks and schedules.
  • Multi-tasking, ability to achieve deadlines, work under pressure, coping with more than one conflicting task at once.
  • Strong compliance.
  • Computer Skills to include MS office.
  • Proven time management skills.
  • Familiarity with cGMPs relating to pharmaceutical manufacturing.
  • Excellent Communication skills, both verbal & written.
  • Strong attention to detail is critical.
  • Adaptability – maintain effectiveness in varying environments and with different tasks, responsibilities and people.

 

2020-307 - Senior Manufacturing Engineer - Waterford City

Purpose:

A highly technical role required to support, debug and improve complex automation systems. Technical expertise is also required to identify and implement cost justified process improvements. For this particular position, a good working knowledge of Excel VBA is essential.

Responsibilities:

  • Manage FILM process yield measurement and improvement activities.
  • Manage FILM measurement systems including OEE, yield, and uptime / performance tracking.
  • Utilise Lean Six Sigma tools and data to drive continuous improvement.
  • Develop and Implement Safety and Quality improvements.
  • Provide consultative support to the Manufacturing and Maintenance groups.
  • Develop methods to ensure personnel engaged in operations\maintenance activities have sufficient knowledge to perform their assigned tasks.
  • Prepare design specifications and associated documentation for equipment and system upgrades.
  • Fault-finding \ troubleshooting of equipment and process issues.
  • Implement improvements under change control.
  • Be familiar with 21 CFR part 11 guidelines and their application.
  • Present, where appropriate, technical data to internal/external audit and inspection groups.
  • Ensure Health and Safety Regulations and Procedure are adhered to at all times for self and others.

 

Minimum Qualifications and Experience:

  • Bachelors in Engineering (mechanical / electronic) preferred.
  • A minimum of 4 years in technical role in high volume manufacturing environment.
  • Six sigma experience preferred.
  • Excel VBA expertise essential.
  • Good problem solving abilities – able to identify facts, consider alternative approaches and evaluate the most appropriate action.
  • Medical device and/or pharmaceutical industry experience preferred.
  • Experience working in a validated environment with strong discipline with regard to change control is preferred.

 

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.

 

10233 - Technical Writer - Dublin

Responsibilities:

  • Track and drive the completion of the documentation package for the start-up of the site’s Logistics dept.
  • Lead the documentation generation and management of the Warehouse/Dispensary procedures & processes. Leading the related execution of the start-up plan for the Warehouse/Dispensary department for this.
  • Be a “go-to” person in the site Warehouse and Dispensary document control, providing key guidance for documentation related issues.
  • Help in the start-up of the Warehouse & Dispensary Operation, helping the team to support with all documentation related issues as it related to C&Q activities, developing processes/SOP and giving input in the development of COMET (SAP), LIMS and MES.
  • As needed by the business, support other related GMP task as needed.
  • Create and maintain templates for all required forms & templates within the department.
  • Facilitate document reviews with cross functions groups, Engineering, MS&T, QC, QA, etc.
  • Implementation corrective and preventative actions which are related to Dispensary, Warehouse & Logistics documentation.
  • Contribution towards Warehouse & Dispensary departments non-conformance/deviation write ups, working with relevant staff members to reach a true root cause and ensure improvements to the processes.
  • Contribute toward, promote & facilitate Continuous Improvements and Process improvements within the Warehouse/Dispensary Operations area. Using best practice lean tools and following company Production Systems philosophies.
  • Run required department training needs reports, ensuring that the relevant training is up to date per person, following up with associates to ensure focus on training is given and therefor maintaining a 100% training record for the department.
  • Work with site planners/schedulers in order to aid the area Manager to ensure that that the areas workload is correctly level loaded to maximize efficiency across the project timelines.
  • Provide support to the Warehouse & Dispensary department in order to provide a culture of continuous improvement with regard to the on-site distribution of materials to key internal customers, i.e. manufacturing, Labs, MS&T, etc.
  • Generate documentation for training materials to include both the operating principles and also key steps for successful operation; select photographs, drawings, sketches, diagrams, and charts to illustrate material.

 

 

Minimum Qualifications and Experience:

  • Preferably a Level 7 qualification in a related discipline.
  • Knowledge of GMP/FDA regulatory requirements, housekeeping, health and safety.
  • Knowledge of validation an advantage but not essential.
  • Previous experience of working within a Known Consignor approved warehouse an advantage.
  • Demonstrated ability to performed technical documentation writing, i.e. SOP’s FORM’s, batch Records, etc.
  • Capability to interact and communicate with all levels of operational teams and greater Supply Chain team.
  • The ability to influence decision making in a manner that achieves the best possible solution for the organization.
  • Ideally have an understanding of how a Dispensary & Materials process flows work with Supply Chain team that is required to support a manufacturing facility.
  • Possess the ability to communicate with both technical resources and operators to incorporate both the theoretical and practical components for process training.
  • Ability to use electronic documentation systems for review/approval of SOP’s, write up of Deviation/Non-Conformances, etc.
  • Experience in key Microsoft packages, Word, Excel, Powerpoint, etc in order to communicate messages to shop floor associates, peers and department leaders.
  • Knowledgeable on use of equipment used in a RM Sampling/Dispensary Operation, i.e. Downflow booths, scales, Fumehoods, drum movers, etc would be a distinct advantage.
  • Preference for candidate to have a good knowledge of the overall Drug Substance manufacturing process (Upstream & Downstream processes.)
  • Ability to understand technical documentation relevant to tech transfer (process flow diagrams, tech transfer documentation, and master batch records.)
  • Review manufacturer’s and trade catalogs, drawings, and other data relative to operation, maintenance, and service of equipment.
  • Ability to interact with multiple stakeholders across numerous departments.
  • Excellent communication skills and the ability to work in a cross functional collaborative environment.
  • Good interpersonal skills, attentiveness and an approachable manner for interactions with inter-departmental colleagues.
  • High degree of problem-solving ability and adherence to scheduled timelines.

 

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.

 

2019-305 - Manufacturing Engineer - Waterford

Purpose:

The Lens Manufacturing Engineer role is a highly technical role required to support, debug and improve complex automation systems in a high-volume, medical device manufacturing facility.

Responsibilities:

  • Develop \ design and implement cost justified process and equipment improvements with minimal impact to production operating under 24/7 environment.
  • Identify and eliminate repetitious machine failures.
  • Provide consultative support to the Manufacturing and Maintenance groups.
  • Utilise Lean Six Sigma tools and data to drive continuous improvement.
  • Develop and Implement Safety and Quality improvements.
  • Develop methods to ensure personnel engaged in operations\maintenance activities have sufficient knowledge to perform their assigned tasks.
  • Prepare design specifications and associated documentation for equipment and system upgrades.
  • Fault-finding \ troubleshooting of equipment and process issues.
  • Installation, Commissioning and Validation of automation.
  • Implement improvements under change control.
  • Develop Functional and Detailed Design Specifications from formal and informal User Requirement Specifications.
  • Be familiar with 21 CFR part 820 guidelines.
  • Present, where appropriate, technical data to internal/external audit and inspection groups.
  • Ensure Health and Safety Regulations and Procedure are adhered to always for self and others.

 

 

Minimum Qualifications and Experience:

  • Bachelor’s Degree in engineering (mechanical \ electronic) preferred.
  • A minimum of 3-5 years in technical role in high volume manufacturing environment.
  • Solidworks experience preferred.
  • Six sigma experience preferred.
  • Good problem-solving abilities – able to identify facts, consider alternative approaches and evaluate the most appropriate action.
  • Medical device and/or pharmaceutical industry experience preferred.
  • Experience working in a validated environment with strong discipline with regard to change control is preferred.

 

 

10208 - QC Specialist - 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 strategic company Drug Substance 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 company and the biotechnology industry. Together, the team will build the future of company biologics through a Quality culture that delivers unconstrained supply, Right First Time to our patients through an inspired team. 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 programmes.
  • 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.
  • Preference Lean Six Sigma.
  • Good verbal and written communication skills.
  • Experienced in testing as per the pharmacopeia.
  • Working knowledge of QC Systems (Empower, elogs, Electronic Lab Notebook, LIMS.)

 

 

2019-304 - CSV Engineer - Waterford City

Responsibilities:

  • Preparation and execution of computer software validation protocols, test scripts and reports.
  • Evaluation of changes to validated/qualified Systems from a Computer Systems/Software Validation perspective to ensure their continued validated/qualified state.
  • Lead and participate in risk management activities e.g. FMEAs.
  • Investigation of software related deviations and non-conformances as part of quality team.
  • Review of all software related GMP critical documents, e.g. Requirement documents, software validation protocols, Change Controls.
  • Participate in software corrective action process e.g. perform root cause investigations and develop CAPA plans.
  • Review of pre-delivery or vendor-supplied information with regards to suitability to proceed with validation activities.
  • Travel to vendor locations for project reviews will be required.
  • Provide technical expertise in the validation of new technologies to ensure they meet the Safety, Quality and Operational requirements.

 

 

Minimum Qualifications and Experience:

  • Degree in Engineering or computing discipline or other similar technology degree.
  • 3-5 years’ experience in a similar role within engineering or computer system validations.
  • Experience in high-volume low-cost manufacturing systems.
  • Knowledge of software development life cycle methodologies.
  • Knowledge of statistical analysis and machine vision fundamentals would be a plus.
  • Participation in team-based project work with cross-functional team members.
  • Ability to communicate Validation concepts/strategies to project teams.
  • Be a self-starter and be adaptable to a fast-paced working environment.
  • Be able to integrate into current groups and interact well with people.
  • Desirable: Experience with vendor equipment builds, process automation, machine vision systems and medical products.
  • Experience working in a cGMP/FDA regulated environment.
  • Knowledge of latest regulatory/industry standard approaches to Data Integrity.

 

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.

 

10151 - Senior EHS Support - Dublin

Responsibilities:

  • Under the direction of the Site EHS lead, serve as site EHS representative during mechanical completion, commissioning and qualification activities – part of the project walk-down and start-up team for assigned systems.
    • Ensure that installation is in conformance with PHA recommendations, design intent, local and national regulations and internal company standards.
    • 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.
  • Under the direction of the Site EHS lead, develop procedures to support the implementation of EHS programs at the site in accordance with local and national regulations and internal company standards.
  • Serve as a role model and leader in demonstrating and implementing a healthy and strong EHS culture across the entire site.

 

 

Minimum Qualifications and Experience:

  • Bachelor’s degree in Engineering or related Safety or Environmental field of study.
  • +10 years / +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.
  • Be able to maintain focus on the key project goals and priorities, but also be able to dive into the detail to facilitate problem resolution and ensure project success.
  • Knowledge and experience working with EHS regulations.
  • Strong written and verbal communication skills.
  • Ability to influence both horizontally and vertically.

 

 

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.

 

 

10002 - Scientific Technical Specialist - Cork

Purpose:

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

 

Responsibilities:

  • Knowledgeable in protein chemistry and analytical techniques such as ELISA/Bioassay methods, Method validations, method transfers and Equipment qualifications in a GMP environment.
  • Perform laboratory experiments required to deliver on project timelines.
  • Participate in continuous improvement initiatives, including method optimisation and troubleshooting.
  • Preparation of documentation associated with the projects in accordance with GDP (good documentation practice) and site procedures.
  • Lead and Participate in cross-functional projects, problem solving teams for troubleshooting, and investigations across site.
  • Prepare, review and approval of technical documents, procedures, CAPAs, change control, deviations, metrics, etc.
  • Adhere to highest quality standards.

 

Minimum Qualifications and Experience:

  • Knowledgeable in protein chemistry and analytical techniques such as ELISA/Bioassay methods, Method validations, method transfers and Equipment qualifications in a GMP environment.
  • Perform laboratory experiments required to deliver on project timelines.
  • Participate in continuous improvement initiatives, including method optimisation and troubleshooting.
  • Preparation of documentation associated with the projects in accordance with GDP (good documentation practice) and site procedures.
  • Lead and Participate in cross-functional projects, problem solving teams for troubleshooting, and investigations across site.
  • Prepare, review and approval of technical documents, procedures, CAPAs, change control, deviations, metrics, etc.
  • Adhere to highest quality standards.

 

 

9626995 – CQV Engineer - Athlone

Purpose:

Reporting to CQV lead/system owner.

 

Responsibilities:

  • Commissioning, qualification and verification engineer on Level 2 Clinical project at the site.
  • Responsible for generating CQV test documentation which includes VQAs, VTP, DRRs and test scripts.
  • Execute testing and verification in the field on upstream and downstream processing equipment.
  • Experience with upstream or downstream single use manufacturing processes is preferred.
  • Experience with delta V Manufacturing control systems is required.
  • Raise and close validation deviations where required.
  • Understanding of company ASTM 2500 risk based verification approach for clean utilities, black utilities, downstream and upstream processes.

 

Minimum Qualifications and Experience:

  • Degree level or equivalate.
  • 6-9 years experience.

 

 

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.

 

 

9830 - CQV Engineer - Dublin

Purpose:

The job-holder will work as part of a multi-functional utilities team and will be responsible for the qualification, validation maintenance, revalidation and periodic review activities associated with GMP Critical Utility equipment and systems at the company.

 

Responsibilities:

  • Generation of qualification risk assessment/testing matrix for qualification protocols and supporting documents in line with User Requirements/Equipment Specifications / company and cGMP compliance standards.
  • Preparation and approval of Utilities Validation SOPs.
  • Preparation and approval of Validation test equipment SOP’s.
  • Management of Validation Test equipment with support from site maintenance management team (Calibration/System Maintenance and Calibration Event handling.)
  • Qualification of Validation test equipment.
  • Develop, review and execute GMP critical utility Performance Qualification (PQ) protocols and PQ reports for GMP Critical systems e.g. HVAC, RO/PW/WFI, Clean Steam, Clean Compressed Gasses, walk in cold storage.
  • Equipment/System assessments for ‘Computer System Qualification’ requirements and ‘Execution of Electronic Records and Electronic Signatures’ requirements.
  • Identify, document and track validation events.
  • Full oversite of all personnel and contractors participating or executing PQ activities, ensuring all team members are trained and follow the relevant site procedures.
  • Responsible for ensuring documentation being leveraged for PQ testing from project commissioning phase/IQ/OQ are referenced as per associated qualification, referencing procedures.
  • Responsible for validation tasks/actions associated with quality system change controls and investigations where required.
  • Development/Generation of Utilities Validation Master Plan.
  • Periodic review and revalidation assessment.

 

Minimum Qualifications and Experience:

  • Minimum qualification BSc or MSc/M.Eng Degree in Engineering or equivalent discipline.
  • Must have excellent verbal and written communication skills.
  • Having a minimum of 5 years in an Engineering CQV role with extensive cGMP experience in Commissioning Qualification & Validation, ideally covering GMP Critical Utilities Equipment Engineering.
  • Have good understanding of Instrumentation/Calibration, Utilities Equipment incl. HVAC, WFI/RO/PW, Clean Steam Gases, Refrigeration Systems.
  • In depth knowledge and experience with validation test equipment/systems.
  • A good understanding of associated Maintenance/Calibration requirements of such systems is also a requirement.
  • Have the capability and experience to manage Vendors and Contractors supporting PQ activities.
  • Ability to work independently and as part of a team in a cross functional collaborative environment.
  • Proven track record in managing and delivering projects.

 

 

9976 - Technical Support Analyst - Cork

Responsibilities:

  • Good knowledge of protein chemistry and analytical techniques particularly HPLC.
  • Perform laboratory experiments required to deliver on project timelines.
  • Participate in continuous improvement initiatives, including method optimisation and troubleshooting.
  • Support small scale analytical test method optimisation activities.
  • Preparation of documentation associated with the projects in accordance with GDP (good documentation practice) and site procedures.
  • Participate in cross-functional problem.
  • Solving teams for troubleshooting and investigations and Quality functions.
  • Support lab compliance with site safety and environmental standards.
  • Prepare and review of technical documents, procedures, metrics, etc.

 

Minimum Qualifications and Experience:

  • MSc/BSc. qualification (Science.)
  • At least 2 years’ experience in an analytical/ small scale process development role in QC or an analytical/process development group.
  • Experience with ASTRA & EMPOWER software, Agilent/Waters HPLCs preferred but not required.
  • High level written and verbal communications with advanced PC skills.
  • Self-motivated and ability to work as part of a team with good project management skills.
  • Demonstrated ability to fully realize improvement initiatives.
  • Demonstrated successes in a team environment, such as project teams, problem solving teams etc.

 

 

9968 - Supply Chain Specialist - Carlow

Responsibilities:

  • Ensure that all material requirements are forecasted in a timely manner.
  • Support SAP Resources Build and engagement with MES Team.
  • Develop and maintain accurate Planning BOMs at both Material and Run Time level.
  • Develop schedule for lab planning requirements.
  • Contribute to the 4-24 month Warehousing Capacity requirements planning process.
  • Liaise with stakeholders to understand requirements for New SKU creation and co-ordinate these requests with the site Master Data Team.
  • Comply with all company and local regulations, guidelines and procedures.
  • Works with moderate work direction and is skilled and knowledgeable to the position.

 

Minimum Qualifications and Experience:

  • Prior Experience of SAP Master Data or another ERP System.
  • APO/ECC Planning or another ERP System.
  • APICS Desired Responsibilities.
  • Advantage to have previous experience in GMP environment.

 

 

9985 - New Product Introduction - Support Specialist - Dublin

Responsibilities:

  • Support planning and scheduling activities for future product introductions.
  • Aligning stakeholders on capital project scope.
  • Determining optimal approach to facility shutdown, capital project execution, commissioning/qualification/validation, technology transfer and startup activities.
  • Building an integrated project plan and effectively communicating to stakeholders.
  • Supporting development of capital cost estimates.
  • Achieve the above by partnering with global process development teams, site technical, automation/IT, operations and facilities/engineering groups – while maintaining an end-to-end product focus.
  • Develop site standard work for NPI.
  • Maintain continuous focus on quality and safety compliance and unflinching focus on the customer.

 

Minimum Qualifications and Experience:

  • A bachelor’s degree (or higher) in Biological Sciences/Chemical Engineering/Biological Engineering/Chemistry.
  • Strong contemporary knowledge.
  • The ability to deliver what is needed on-time, holding self and team accountable for commitments, decisions, actions and behaviours.
  • The ability to effectively articulate understanding of process engineering and project management, in order to drive decision making, impact assessments, etc., in a multi-disciplinary team environment.
  • Proven track record in managing and delivering projects.

 

 

9933 - Process Engineer - Carlow

Purpose:

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

Responsibilities:

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

 

Minimum Qualifications and Experience:

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

 

 

9934 - Process Engineer - Carlow

Purpose:

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

Responsibilities:

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

 

Minimum Qualifications and Experience:

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

 

 

9932 - Validation Engineer - Carlow

Purpose:

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

Responsibilities:

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

 

Minimum Qualifications and Experience:

  • With relevant technical qualification(s) in Applied Pharmaceutical / Biological / Computer / Chemical sciences or applied Technical / Engineering qualification.
  • Experienced individual with a minimum of 5 years directly related experience in academia, pharmaceutical or biotechnology industry.
  • Minimum 3 years process equipment C&Q/ Validation experience on Large Scale Projects.
  • 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.
  • The ability to effectively articulate understanding of process science, in order to drive decision making, impact assessments, design of studies, etc., in a multi-disciplinary team environment.
  • The candidate will also show ambition and drive to develop and advance within the role.
  • SME on Equipment Validation on any of; CIP & Parts Washer / SIP / Autoclaves / DHT & Electron Beam sterilisation / Vaporised Hydrogen Peroxide Sterilising Isolators / Clean Utilities Transfer Panels & Formulation Vessels.
  • Working knowledge of ASTM E2500 / Eudralex / FDA / ISPE guidelines.
  • Experience with liaising with other departments – engineering, technical, operations and QA.
  • Experience with sterile processing and sterilisation technologies.
  • Experience with cleaning and process validation, technology transfer, regulatory filing, and commercial drug product manufacturing of biologics is a plus.
  • Prior experience in drug product processing equipment, PQ, Process Performance Qualification and Validation, site readiness, batch record reviews, authoring documents subject to regulatory inspection.
  • SIP and CIP subject matter extensive experience.
  • Autoclave Qualification and Sterilisation Loads Cycle Development experience.
  • Use of temperature mapping equipment such as Lives/ Kaye etc. and trending, analysing and interpreting complex data.
  • Warehouse and CTU qualification.
  • Desirable –
    • Visual Inspection technologies for Vial & Syringe.
    • Vial & Syringe processing technologies; drug product filling, glass handling, tray handling, stoppering, capping and CCI.
    • New facility brown/ green field facility experience.
    • Small equipment qualification and validation; FITs, Scales, Tube Sealers/ Welders, Headspace analysers, Flowmeters, Mobile Vessels & Single Use Technologies.
    • Project Management experience / training in use of Project Management tools.

 

 

9865 - IT Project Scheduler - 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.

 

9969 – Validation Engineer - Dublin

Purpose:

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

 

Responsibilities:

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

 

Minimum Qualifications and Experience:

  • A Bachelor’s degree (or higher) in Biological Sciences/Chemical Engineering/Biological Engineering/Chemistry (or PhD without industry experience.)
  • Minimum of 3 years’ (for BSc) directly related experience in academia, pharmaceutical or biotechnology company.
  • A working knowledge of current regulatory requirements and current Good Manufacturing Practices.
  • A strong contemporary knowledge.
  • Demonstrated the ability to deliver what is needed on-time, holding self and team accountable for commitments, decisions, actions and behaviours.
  • The ability to effectively articulate understanding of process science, in order to drive decision making, impact assessments, design of studies, etc., in a multi-disciplinary team environment.
  • Experience with upstream cell culture and/or downstream purification of biological molecules.
  • Experience with technology transfer, regulatory filing, and commercial drug substance manufacturing of biologics is a plus.
  • Technical operations experience in the drug substance manufacture of biological molecules at the pilot- and/or commercial-scale.
  • Prior experience in drug substance, process performance qualification and validation, site readiness, batch record reviews, authoring regulatory CTD sections and/or working with external contract organisation for development and/or manufacturing.
  • Temperature Mapping Experience.
  • Cleaning Validation Experience.
  • Autoclave Experience.

 

9915 - Scientific Technical Specialist - Cork

Purpose:

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

 

Responsibilities:

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

 

Minimum Qualifications and Experience:

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

 

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.

 

9839 - Validation Engineer - Carlow

Responsibilities:

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

 

Minimum Qualifications and Experience:

  • This role requires an experienced individual with a minimum of 5 years directly related experience in academia, pharmaceutical or biotechnology industry – along with a working knowledge of current regulatory requirements and current Good Manufacturing Practices.
  • Minimum 3 years process equipment C&Q/ Validation experience on Large Scale Projects
  • A self-starter and results-focussed, the successful candidate will have strong contemporary knowledge, and the ability to work independently and on multidisciplinary teams.
  • The successful candidate will also have demonstrated the ability to deliver what is needed on-time, holding self and team members accountable for commitments, decisions, actions and behaviours.
  • They will also have excellent oral and written communication skills, with the ability to effectively articulate understanding of process science, in order to drive decision making, impact assessments, design of studies, etc., in a multi-disciplinary team environment.
  • With relevant technical qualification(s) in Applied Pharmaceutical / Biological / Computer / Chemical sciences or applied Technical / Engineering qualification, the successful candidate will also have a proven track record in delivering excellence.
  • The candidate will also show ambition and drive to develop and advance within the role.
  • SME on Equipment Validation on any of; CIP & Parts Washer / SIP / Autoclaves / DHT & Electron Beam sterilisation / Vaporised Hydrogen Peroxide Sterilising Isolators / Clean Utilities Transfer Panels & Formulation Vessels.
  • Working knowledge of ASTM E2500 / Eudralex / FDA / ISPE guidelines.
  • Experience with liaising with other departments – engineering, technical, operations and QA.
  • Experience with sterile processing and sterilisation technologies.
  • Experience with cleaning and process validation, technology transfer, regulatory filing, and commercial drug product manufacturing of biologics is a plus.
  • Prior experience in drug product processing equipment, PQ, Process Performance Qualification and Validation, site readiness, batch record reviews, authoring documents subject to regulatory inspection.
  • SIP and CIP subject matter extensive experience.
  • Autoclave Qualification and Sterilisation Loads Cycle Development experience.
  • Use of temperature mapping equipment such as Lives/ Kaye etc. and trending, analysing and interpreting complex data.
  • Warehouse and CTU qualification.
  • Visual Inspection technologies for Vial & Syringe.
  • Vial & Syringe processing technologies; drug product filling, glass handling, tray handling, stoppering, capping and CCI.
  • New facility brown/ green field facility experience.
  • Small equipment qualification and validation; FITs, Scales, Tube Sealers/ Welders, Headspace analysers, Flowmeters, Mobile Vessels & Single Use Technologies.
  • Project Management experience / training in use of Project Management tools.

 

9907 - Business Consultant - Carlow

Purpose:

The site Knowledge Management (KM) Site Lead will help unlock & retain site knowledge for business continuity and enable the flow of critical knowledge for products and processes (technical and business) within the site as well as between key partners and organization.

 

Responsibilities:

  • The KM Site Lead will leverage the KM CoE to help identify site needs and opportunities to improve and promote knowledge flow with a focus on key products and processes that enabler product realization activities, from commercialization, launch, & supply (e.g. capture of tacit knowledge, technology transfers, investigations, etc.)
  • Leverage KM strategic imperatives to ensure site knowledge is managed as an asset for business continuity, foster collaboration, ensure connectivity and enable the greatest value from project and site knowledge.
  • Champion knowledge flow within the site and across other sites in the supply chain that manufacture the key products of the site. KM CoE will support and enable with training, coaching, standard work, tools, techniques, templates, guides and other assets. The OpU KM Business Partner will be a key linkage to the KM CoE. The KM Site Lead will be an active member of a KM practitioner community with leads from other sites and functions and have the opportunity to partner in development of new KM capabilities at a regional or global level. The individual will be engaged with the full KM community across the MMD network, gaining insights about other sites, functions and leadership.
  • Partner with site leadership team members and their respective teams to evaluate and identify areas of opportunity/gaps in knowledge flow (pain points) for prioritized areas , leveraging assessments and knowledge mapping as appropriate.
  • Develop and maintain the site KM plan that links to the site Hoshin, objective and Operating Units KM focus areas.
  • Lead deployment of the site KM plan, as linked to the site objective and priorities.
  • Measure progress against the site KM plan. Gather, monitor and report progress of KM initiatives to site and KM CoE leadership with metrics.
  • Serve as the site KM SME and lead KM practitioner providing the following:
    • After Action Review (AAR) facilitation as a certified AAR practitioner.
    • Knowledge mapping.
    • Training for KM Tools TK, Take 5, Vitual Talent Network and any other standard KM tools.
  • Supports the design, implementation, and enhancement of core KM approaches used to support capture and share critical knowledge flowing critical knowledge flow within key site business processes and between the site and global organizations supporting the commissioning, qualification and filing.
  • Ensures site content is managed in a way to allow site personnel to find and utilize knowledge in an efficient manner.
  • Responsible for deployment of new KM capabilities at the site and determines where core KM capabilities should be deployed, utilized and leveraged to business benefit.
  • Provides valuable feedback to the KM CoE on KM business impacts and contributes to next generation solutions through participation on benchmarking activities.

 

Minimum Qualifications and Experience:

  • Bachelor’s degree in a Science or Engineering discipline.
  • Desirable to have a Masters in a related discipline.
  • A minimum of 5 years experience working on a biopharmaceutical manufacturing site.
  • Evidence of Continuous Personal Development.
  • Desirable: Six Sigma Green Belt.
  • Demonstrated ability to design and facilitate workshops, meetings, and / or large or small groups to drive successful outcomes.
  • Well-developed leadership skills (strategic thinking, high emotional intelligence, strong facilitator and negotiator, agent of change, effective communicator, skillful listener and application of inclusion principles.)
  • Clear understanding of business situation and processes, and can map processes as required, and good working knowledge of organizational and business strategy.
  • Ability to contract with and influence leaders in the organization, good at networking, collaboration and sharing of ideas and success.
  • Ability to elicit requirements and anticipate customer needs, at both operational and strategic levels, and ability to deliver solutions that meet or exceed customer expectations.
  • Ability to think strategically for long term vision and in terms of culture, behavior, business processes and tools yet can meet tactical needs and tailor solutions to be fit-for-purpose.
  • Has an understanding of KM principles and first-hand experience in KM techniques desirable, such as professional networking / social media; taxonomies; expertise location; best practices transfer; lessons learned; and other common processes.
  • Understanding of Lean diagnostics techniques including SIPOC and process mapping to elicit customer requirements and design solutions to meet these requirements.
  • Understanding of pharmaceutical product lifecycle phases including typical types of product and process knowledge. Experience generating or managing product and process knowledge in the commercialization /product manufacturing lifecycle phase of pharmaceutical manufacturing is desired.

 

9902 - Electrical Specialist - Cork

Responsibilities:

  • Act as designee for Site Electrical Lead when required.
  • Oversee the timely completion of Electrical work orders and resolve issues if required. Ensure compliance for same.
  • SN 23 – Electrical Safety Standard program implementation.
  • SN 22- Lockout /Tagout implementation.
  • Assist with continuous and reliable supply of Electricity across the site.
  • Task Supervise & Manage Electrical projects.
  • Plan & schedule Electrical maintenance.
  • Support audits on the Electrical Safety program.
  • Point of contact for Electrical related queries.
  • Liaise with Electrical / Maintenance contractors.
  • Task Supervisor and Area Owner for Electrical related work.
  • Review and approve Electrical modifications, change requests, and SOP’s.
  • Conduct walk-downs / review of electrical installations.
  • Attend Factory and Site Acceptance Tests as required.
  • Identify opportunity for improvement in Electrical distribution / maintenance infrastructure.
  • Identify and implement Electrical based training across site.
  • Coaching others by sharing skill-set and expertise.
  • Complete assigned training – and identify gaps /opportunities for further training.

 

Minimum Qualifications and Experience:

  • Qualified Electrician + 3 years post apprenticeship experience.
  • Engineering Degree desirable.
  • At least 3 years’ experience in the Pharmaceutical industry or a similar operating environment.
  • Experience of High Voltage equipment.
  • Strong Safety mindset & awareness of the potential dangers inherent in High and Low voltage distribution.
  • Strong Compliance Mindset, demonstrated capability of understanding EHS & GMP compliance requirements (particularly from an Engineering perspective), demonstrated capability within the Audit environment (specifically EHS.)
  • Technical knowledge.
  • Computer literate – required for CMMS work order processing / Training completion etc.
  • Ability to respond to competing priorities.
  • Communications skills.
  • Problem solving skills.
  • Very strong knowledge of industrial Electrical safety standards.
  • Demonstrated continuous improvement focus.
  • Customer Focus – proven ability to delight customers & end users.

 

9469112 - Cleaning Validation Specialist - Dublin

Purpose:

The Cleaning Validation Technical Specialist will support the cleaning validation activities for the cGMP manufacture of biological bulk drug substance (BDS) at the facility. The Specialist will provide cleaning validation expertise to support the start-up cleaning verification/validation 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 and Quality Control, and other involved departments to ensure successful facility startup and cleaning verification/validation activities. 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:

  • Maintain/update input to the Cleaning/Validation Master Plan to support the startup of the multi-product drug substance manufacturing facility.
  • Develop and implement/update cleaning strategies for fixed and mobile parts.
  • Development/update 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 for new product introductions.
  • Generate and execute cleaning validation protocols as required. Provide input to Standard Operating Procedures (SOPs) and Work Instructions (WI) to enable suitable cleaning sampling activities to occur.
  • Work closely with colleagues within the Technical Services team, and with Quality, Manufacturing Operations, and Automation MCS to ensure CIP recipes, batch record instruction and standard work practices meet the needs of process transfer, and routine manufacturing timelines in the context of cleaning verification/validation.
  • Author and review process transfer/cleaning documentation, cleaning risk assessments, technical protocols and reports, cleaning verification/validation documents and supporting documentation as required. Lead/facilitate and partake in cleaning verification/validation deviations and exceptions to support closeout of verification and validation protocols.
  • 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.)
  • Identify and implement improvements where feasible.
  • Lead the execution of cleaning trials and studies, verification and validation protocols on the manufacturing floor at commercial scale relating to typical BDS manufacturing areas. Temporary shift working may be required during periods of engineering batch and validation batch execution, and participation in on-call roster.
  • Provide on the floor support for troubleshooting cleaning related issues and may lead manufacturing investigations into process deviations.
  • Author and review technical documents for SOPs, master data, material specifications and/or regulatory agency submissions which related to cleaning activities.
  • Serve as a subject-matter expert on cleaning validation activities during regulatory agency inspections.

 

Minimum Qualifications and Experience:

  • Minimum requirement B.Sc. in Biochemistry, Biology, Chemistry or equivalent, or B.Eng. Process or Chemical Engineering or similar qualifications.
  • Minimum 2-3 years’ plus experience in Technical Services / Manufacturing / Technical Development/Quality Support in a biological bulk drug substance manufacturing organization.
  • Technical and operational knowledge of Cleaning validation/verification, quality systems and regulatory requirements across multiple health authorities.
  • Experience of cleaning verification/validation is a must, and/or cleaning approaches to multiproduct is advantageous.
  • Experience of cleaning verification/validation of upstream (bioreactors, tanks) and downstream processing equipment (Chromatography skid, UFDF/TFF skids, Filtration skids, and process hold vessels.)
  • 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.

 

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.

 

9882 - Project Lead - Black Utilities - Carlow

Purpose:

Reporting to the site 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:

  • Reporting to site Project Manager.
  • 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.

 

9815 - Senior Project Engineer - Carlow

Responsibilities:

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

 

Minimum Qualifications and Experience:

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

 

9789 - Decommissioning Engineer - Cork

Purpose:

This position will provide technical support to the Technical Operations COE to support the decommissioning of manufacturing equipment. This requires the application of technical & engineering excellence to deliver all components of a stable process, supported by a flexible, collaborative, multi-skilled teamwork environment.

Responsibilities:

  • Responsible for line decommissioning.
  • Generates of SDLC retirement plans and summary reports.
  • Executes decommissioning plans including archiving computerized control system programs and obtain SDLC packages.
  • Take part in project meetings.
  • Assists with troubleshooting of computerized systems.
  • Archive computerized system software.
  • Works with moderate work direction.
  • Skilled and knowledgeable to the position.

 

Minimum Qualifications and Experience:

  • Degree in a Science or Engineering discipline with over 5 experience in a manufacturing environment working in FDA-regulated industries within the areas of Validation, Quality, Manufacturing and/or Engineering.
  • Demonstrated knowledge in Commissioning, Qualification and/or Validation (CQV) with experience in Bio-process manufacturing operations.
  • Experience writing protocols/reports, performing execution of activities associated with process equipment used in manufacturing, troubleshooting or mitigation of discrepancies.
  • Experience providing technical assessments for deviations, risk assessments, CAPAs, GMP investigation and change controls, assessing proposed changes to validation process to identify requirements necessary to maintain validation status.
  • Experience with Factory Acceptance Testing (FAT), Site Acceptance Testing (SAT), Installation, Operational and/or Performance Qualification (IQ, OQ and PQ) protocols and final summary reports.
  • Demonstrated high level of problem solving experience.

 

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.

 

9806 - Warehouse Suite Team Lead - Carlow

Purpose:

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

 

Responsibilities:

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

 

Minimum Qualifications and Experience:

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

 

9734 - Technical Support Analyst - Cork

Purpose:

This position will provide technical support for Vaccine technology transfer and scale-up of new processes for Vaccine IPT manufacture meeting the company’s Manufacturing Division Priorities of: Compliance, Supply, HPO, Strategy and Profit Plan. The Associate Technical Specialist will be required to collaborate and facilitate running of activities (e.g. scale-up, PPQ batch manufacture, and licence submissions) in the Vaccine IPT value stream for Technology Transfer of processes to ensure the effective and efficient on-time delivery of these activities. 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 with Technology Transfer but relating to all activities.
  • Work within a team to enable the team’s performance within the Technology Transfer group within Tech Ops Dept.
  • Responsible for the technical transfer and scale–up of a new process into Vaccine IPT.
  • Technical Review and ownership of Global Change management records as required.
  • Recommend technical approaches in line with global and local standards.
  • 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.
  • Contribute for driving a culture of Continuous Improvement by deploying company Six Sigma tools and MPS within the site 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.)
  • 2+ years’ experience in biopharmaceutical/vaccines environment would be an advantage.
  • Demonstrated knowledge in pharmaceutical / biopharmaceutical technical / manufacturing operations. Experience of involvement in a technical project and would be an advantage.
  • Knowledge of Regulations and applicable standards for Quality, Safety, Regulatory within the biopharmaceutical/vaccine area.
  • 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 operation (e.g. manufacturing, technology, validation, engineering, quality or analytical.)
  • Demonstrated knowledge of Technology Transfer within Biopharmaceutical industry (process or analytical.)
  • Demonstrated successes in a team environment, such as project teams, Six Sigma team, PITs etc.
  • Demonstrated high level of problem solving.
  • Stakeholder management of multi decision makers, colleagues, peers and cross functional teams.
  • Experience in a FDA / HPRA Regulated production environment.

 

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.

 

2019-293 - Contact Lens MDR Labeling Compliance Lead – Waterford City

Purpose:

The Contact Lens MDR Labeling Compliance Lead will manage the labeling strategy, changes and activities for the implementation of MDR for all contact lens sites.

 

Responsibilities:

  • Develop MDR Labeling Compliance requirements for all contact lens sites within scope of the project.
  • Create a strategy for the implementation of MDR requirements.
  • Liaise with cross functional teams on the strategy.
  • Communicate with stakeholders ensuring acceptance of labeling changes in regions outside EU who accept CE marked product.
  • Project management of the MDR Labeling Compliance deliverables.
  • Perform gap assessment against the required standards for the labelling portfolio for contact lens.
  • Remediate gaps for labelling for contact lens.
  • Work with cross functional site teams on the implementation of labeling requirements for all products within scope.
  • Ontime delivery of the schedule.
  • Change management activities for the implementation of MDR labeling requirements.
  • Other duties as assigned by CL MDR project lead.

 

Minimum Qualifications and Experience:

  • Third level Qualification in Science or Engineering.
  • Knowledge of labelling regulations.
  • Previous experience of implementing labelling/packaging changes.
  • New product introduction (is an advantage.)
  • Cross functional project team management.
  • Working Knowledge of MS project.
  • Working knowledge of change management systems/processes.
  • Experience project manager.
  • Working knowledge of packaging and labelling process
  • Working knowledge of global QMS systems (e.g. document and change management systems.)
  • Decisive, self-motivated/capable of working on own initiative, and able to prioritise and a proactive approach.
  • High attention to detail.
  • Medical Device or Pharmaceutical experience.

 

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.

 

9759 - Inspection Readiness, Senior Specialist QA - Dublin

Responsibilities:

  • Support the launch and implementation of the Inspection Readiness Program on-site.
  • Support the Site Internal Audit Program to align with start-up activities.
  • Support Compliance direction for the site by ensuring adherence to divisional policies and guidelines as well as applicable Regulatory Requirements.
  • Lead proactive evaluation of site compliance against emerging regulatory trends.
  • Ensure that quality issues are identified, addressed and resolved before activities commences.
  • Be an advocate of continuous improvement in the Quality Management Systems.
  • Initiate and maintain Quality related metrics related to the Site Inspection Readiness program, ensuring effective communication and follow up of same.
  • Lead and perform internal audits (facility, system and walkthrough) in addition to supporting management of the internal audit schedule at the site.
  • Effectively communicate audit/inspection results to stakeholders and site leaders.
  • Evaluate root cause analysis, CAPA responses, monitor CAPA completion, and verify CAPA effectiveness for audits & inspections for complete remediation.
  • Support the preparation and hosting Health Authority inspections and Divisional GMP Audits.
  • Generate and report metrics / trends for program adherence to requirements and effectiveness.

 

Minimum Qualifications and Experience:

  • Bachelor’s degree (or higher) in Chemistry, Biology, Microbiology, Engineering or in a relevant discipline.
  • This role requires a seasoned QA Senior Specialist with a minimum of 8 years’ experience in a similar role in the Pharmaceutical or Biological industry.
  • Must have at least 3 years experience in delivering Inspection Readiness Programs and Internal Audit programs in a regulated environment.
  • 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.
  • Strong contemporary knowledge of relevant cGMPs, regulations and current industry trends.
  • GMP Inspection Readiness & Audit experience in the Pharmaceutical industry.
  • Problem-solving / critical thinking – ability to understand connections between different technical/quality system areas and recognize potential compliance issues.
  • The desire to continuously learn, improve and develop.
  • The motivation to be an inspiring member of a high performing team.
  • Communication, decision making, people influencing and project management skills will be important.
  • A self-starter and results-focused, the successful candidate will have strong contemporary knowledge of relevant GMPs, regulations and current industry trends.

 

9743 - Project Manager IT - Carlow

Purpose:

Reporting to the MMDIT Delivery Lead or a direct report (tbd). Responsible for portfolio delivery to schedule in line with site needs. The ‘portfolio’ will include one or more of 7 (currently) in scope Workstreams. 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/or maintain Project Management processes and related artefacts (e.g. Execution Plan, Charters, RAID Logs, etc.)
  • Recruitment of NMPs (i.e. contractors), arrange on-boarding, etc.
  • Planning, in conjunction with the Scheduler and Workstream Leads.
  • Ensure progress to schedule and budget.
  • Progress and other reporting, as required.
  • Risk, Issue, Action and Decision management.
  • Ensure compliance with SDLC activities & deliverables, including but not limited to:
    • Requirements Specifications
    • Requirements Traceability Matrix
    • Functional Specification
    • Design Specification
    • Code Review
    • Test specification/test script
  • Work closely with the wider project teams and with the wider MMDIT teams.
  • Work closely with Vendors, including System Integrators.
  • Work closely with the QAIT function and ensure their requirements are met in all deliverables.
  • Participate in, and support, relevant project meetings.
  • Chair relevant meetings + ensure all meeting requirements are met (Agenda, Minutes etc.)
  • Liaise with stakeholders on the overall project to ensure clear communication between all parties.
  • Required to comply with Global Policies, Procedures and Guidelines, regulatory requirements and execute current Good manufacturing Practices (cGMP) in the performance of day to day activities and all applicable job functions.

 

Minimum Qualifications and Experience:

  • Minimum of 3 years’ experience in a similar role, ideally in the Pharmaceutical industry.
  • Record of successful project delivery.
  • Relevant Computer Science or Engineering degree or equivalent.
  • Project Management Certification advantageous.
  • Fluent in English, written and verbal.

 

9755 - Data Analyst - Carlow

Purpose:

Reporting to the Team, specifically responsible for delivery of analytics capability. The Data Analytics Engineer will lead the development of acquiring and presenting real time data for use by the business for process improvements. 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 real time data from source systems including but not limited to SAP, PAS-X,Delta V, SCADA, OSI PI and BMS. This candidate will review and ensure vendors compliance with company quality standards. They will represent the Analytics capability at site project meetings, as required.

Responsibilities:

  • Developing and implementing a strategy for process data compilation from various platforms and aggregation of the data into a format suitable for searching and analysis.
  • Developing and implementing a strategy for statistical process control (SPC) and Overall Equipment Effectiveness (OEE.)
  • Collaborating with commercial manufacturing teams to support facility start-up activities and providing on-the-floor support for drug substance manufacturing.
  • Leading assignment execution against accelerated, critical-path timelines in a right-first-time manner.
  • 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.
  • 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 5 years’ experience in a similar role, ideally in the Pharmaceutical industry.
  • Expert knowledge of GAMP5.
  • Strong experience in one or all the following systems: OSI PI, Hadoop (and related components), Spotfire, QLIK.
  • Strong interpersonal and communication skills (verbal and written.)
  • Fluent in English, written and verbal.

 

9754 - Process Engineer - 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 re-validation
  • 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 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.
  • Knowledge of regulatory/code requirements to Irish, European and International Codes, Standards and Practices.
  • Report, standards, policy writing skills required.
  • Equipment and process validation.
  • Sterile filling processes and equipment.
  • Lean Six Sigma Methodology experience desired.
  • 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 ones own department, understanding the business processes ones department supports.
  • Vendor liaison.
  • Data Analysis.
  • Goal/results orientated.
  • Demonstrable analytical and systematic problem solving skills.
  • Training skills.
  • Strong change management skills.
  • Effective conflict resolution skills.
  • Negotiation skills.
  • Business acumen.
  • Strategy development.
  • Project management skills.
  • Risk management skills.
  • Progressive people management skills.
  • Ability to effectively manage complex.

 

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.

 

2019-292 - MDR Change Management Lead - Waterford City

Purpose:

The Contact Lens MDR Change Management Lead will manage the change management logistics of MDR for all contact lens sites.

 

Responsibilities:

  • Create a change management strategy for the project.
  • Liaise with cross functional teams on the strategy.
  • Manage the change lifecycle through the change management system.
  • Organize international regulatory assessments for all of the CL MDR changes.
  • Create a process for facilitation of requirements to complete regulatory actions.
  • Create and manage detailed interactions of the changes to deliver implementation in line with the programme commitments.
  • Other duties as assigned by CL MDR project lead.

 

Minimum Qualifications and Experience:

  • Third level Qualification in Science or Engineering.
  • MDD and/or MDR and ISO knowledge.
  • Previous experience of managing changes.
  • Cross functional project team member.
  • Working Knowledge of MS project.
  • Working knowledge of change management systems/processes.
  • Experience project manager.
  • Working knowledge of global QMS systems (documentation management, change management.)
  • Good communication skills (verbal & written.)
  • Decisive, self-motivated/capable of working on own initiative, and able to prioritise and a proactive approach.
  • High attention to detail.
  • Medical Device experience.

 

9703 - Project Engineer - Tipperary

Purpose:

Reporting to the Automation IT Project Manager, specifically responsible for the PI Data Historian system and related Reporting. The Data historian Senior 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 team responsible for the full Automation and IT scope and with vendors / partners with responsibility for delivery of systems.

 

Responsibilities:

  • Technical design lead for the Data Historian and Reporting solution including integration to other systems such as Process Automation System and BAS.
  • Actively participates in the creation of project deliverables such as design documents, configuration build, installation and validation activities as required by the Automation IT Project Manager.
  • Ensure technical delivery of Data Historian and Reporting systems as endorsed by leadership team to meet business objectives.
  • Site Data Historian and Reporting platform architecture, system ownership and lifecycle management.
  • Defining and maintaining the site Data Historian and Reporting roadmap.
  • Responsible for regular communication to project leadership & multi-functional team stakeholders.
  • Assures all design & project work is completed in compliance with all Regulatory requirements including, Quality (cGLP/GMP’s), EHS, Global Engineering, design & construction directives, requirements & procedures, as well as all Local/Federal Regulatory requirements.
  • Supports the project manager on schedule and budget development and control.
  • Development of the Data Historian and Reporting team resources for the project and other supporting vendors.
  • Supporting development of the Data Historian and Reporting project execution plan, scope of work for the contract firms or specialists, and provide technical guidance during the execution of their work
  • Contributes to a high performance culture by recognising and resolving issues as they arise.
  • Creates Electronic Dashboards to support Business Information Management.

 

Minimum Qualifications and Experience:

  • Bachelor’s Degree in Engineering, Information Systems, Computer Science or the Life Sciences.
  • At least 6 years’ experience providing process control and information systems solutions.
  • Experience directing system design, configuration and application of business processes in a biopharmaceutical manufacturing environment.
  • Experience during project delivery and operations support of Data Historian and Reporting systems. Experience with the following systems is preferred; OSI-PI, PI-AF, RT Reports, Kepware, Factorytalk. Experience with process control systems would also be advantageous.
  • Experience with designing information interfaces, data conversion, and network and infrastructure fundamentals.
  • Ability to anticipate, evaluate and resolve multiple, simultaneous project issues, delays and problems by utilising technical, project management, and business expertise.
  • Ability to translate strategic opportunities and emerging technology solutions into tangible pragmatic executable plans.
  • Working knowledge of GAMP software development lifecycle, ANSI/ISA-S88 and S95 industry standards. Thorough knowledge of Pharmaceutical Industry Regulations (cGMP/cGLP, OSHA, EPA/EQB) required.
  • Previous experience of Oral Solid Dose manufacturing will be advantageous.
  • Previous experience of high containment manufacturing will be advantageous.

 

9700 - Computer Systems Automation Engineer - Tipperary

Purpose:

Reporting to the OEB4 AIT Project Manager, specifically responsible for Computer System Validation (CSV). The Lead CSV engineer will lead the development of key AIT quality documents, such as Quality Assurance (QAPs) test plans, Quality assurance summary reports, ensuring adherence to company and regulatory standards. This candidate will be required to work closely with the OEB4 AIT teams responsible for the full Automation and IT scope and with vendors / partners with responsibility for delivery of systems. This candidate will review and ensure vendors compliance with company quality standards. Candidate will represent the CSV function at AIT and other OEB4 project meetings, as required.

 

Responsibilities:

  • As the CSV senior engineer for the project you will manage subordinate CSV resources and provide clear direction for systems validation approach within the project.
  • 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 QA-IT function and ensure their requirements are met in all deliverables.
  • Align with the company HPV program: leverage existing documents & expertise where feasible.
  • Approval 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 5 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: PLC/SCADA systems, DCS, MES, OSI PI.
  • Previous experience of Oral Solid Dose manufacturing will be advantageous.
  • Previous experience of high containment manufacturing will be advantageous.
  • Fluent in English, written and verbal.

 

9682 - Automation Project Manager - Tipperary

Purpose:

Reporting to the Associate Director for Automation, specifically responsible for Management of discrete capital projects encompassing Automation Systems on site. This candidate will be required to manage all aspects of project delivery including budget, scope, vendor management and management of project team on site. The candidate will work closely with other disciplines on site and with above site teams to ensure successful delivery of the overall program.

 

Responsibilities:

  • As the Automation Project Manager, you will be responsible for successful delivery of the project.
  • You will work with the overall project team to develop and manage AT scope from basis of design to project closeout.
  • Partner with local business leadership and project teams to deliver scope for Automation aspects of capital projects bringing knowledge of Automation technologies and the Manufacturing Systems Architecture.
  • Financial accountability for Automation Spend.
  • Understand and educate local project teams on automation standards as they relate to technology selection, system configuration, SDLC, validation, hardware, software environments and business processes.
  • Develop and execute project staffing plans if required.
  • Close liaison with Process Engineering Lead and Engineering Contractors.
  • Drive efficiencies in execution of projects to reduce costs and cycle times based on standards.
  • Engage with stakeholders at all levels of projects, including active participation in Project Steering teams.
  • Ensure that SDLC is appropriately applied.
  • Assist with recruitment of AIT project team, day to day management of team members.
  • Manage and control change within the project to critical project constraints.
  • Work closely with vendors of Automation equipment to ensure deliverables meet project requirements, including the interfacing of new Automation equipment with existing site systems, incl. MES and PI Historian.
  • Work closely with the QA-IT and CSV functions and ensure their requirements are met in all deliverables.
  • Develop project schedules and document trackers to manage and control project deliverables.
  • Liaise with stakeholders on the overall project to ensure clear communication between all parties.
  • Ensure Automation compliance 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:

  • Degree in Engineering, computer science or a related discipline. An advanced degree would be advantageous.
  • 10+ year’s experience in pharmaceutical manufacturing industry, including minimum 5 years’ experience in a similar role.
  • Project Management certification would be desirable (e.g. PmP or PRINCE2.)
  • Experience managing multi-functional teams to meet project goals.
  • Experience delivering projects using one or more of the following systems: ABB DCS (MOD300, Advant, 800XA), Emerson DeltaV or other DCS. Experience with the following systems would be advantageous; OSISoft PI, Warem PasX, Allen Bradley PLC/SCADA.
  • Previous experience of API manufacturing will be advantageous.

 

9571724 - Technical Services Specialist - Dublin

Purpose:

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

 

Responsibilities:

  • Provide significant fill-finish technical expertise to support all aspects of the manufacturing of commercial and late stage clinical products at CMOs.
  • Lead troubleshooting efforts and high-level deviation investigations in conjunction with contractors and internal partners (Process Development, Manufacturing, and Quality.)
  • Support all aspects of the manufacturing process from raw material selection and specification through formulation and filling to visual inspection, testing and release.
  • Technical review of change controls for impact to product quality, safety and efficacy.
  • Provide on-floor technical support and troubleshooting at the CMO facility.
  • Identify and then lead process optimization initiatives and address opportunities for efficiency and capacity improvements in all areas of manufacturing.
  • Technical protocol and summary report generation as related to technical studies executed in direct support of GMP manufacturing activities.
  • Collection, organisation, trending, and analysis of GMP manufacturing data.
  • Identify manufacturing best practices across the network and lead or participate in teams to implement best practices.
  • Support establishment of validation plans and evaluation of drug product production site options.
  • Provide SME input for IND, BLA and other technical documents for regulatory agency submission in support of manufacturing process operated at CMOs.
  • Up to 25% international travel required.

 

Minimum Qualifications and Experience:

  • Minimum BS degree in Scientific (Biochemistry, Biology, Chemistry) or Engineering (Chemical, Mechanical) related field.
  • Minimum of five years’ experience in in fill-finish process development and/or manufacturing support with extensive practical knowledge of liquid fill operations.
  • Experienced in relevant unit operations including mixing, formulation, sterile filtration, sterilisation, aseptic processing, component processing technologies, liquid filling and visual inspection.
  • Comprehensive understanding of cGMP requirements for clinical and commercial biopharmaceutical manufacturing and the ability to implement best practices to ensure multi-product drug manufacturing operations are cGMP compliant.
  • Experience of technology transfers and implementing new clinical and commercial biopharmaceutical manufacturing processes, specifically sterile liquid fill operations.
  • Ability to present and defend technical aspects of manufacturing operations during regulatory agency inspections.
  • Familiarity with protein handling and processing considerations and how operating conditions can impact Critical Quality Attributes (CQA.)
  • Experience of working with CMOs would be a distinct advantage, demonstrating strong communication and influencing skills.
  • Technical transfer experience & be able to lead transfers for vial filling operations in CMOs and PFC operations,
  • Provide technical support to commercial and clinical drug product manufacturing organisations.
  • Liaise between with CMO’s and company GPD.
  • Review & complete Gap analysis, FMEA’s, protocols, report and risk assessments.
  • Travel for F2F, witness / on the floor tech support to Engineering runs & process validation runs.
  • Work with minimum supervision, ability to learn quickly and has strong technical decision making skills.
  • Ability to produce and present to Sr. Mgt – such as slide deck presentations on project status / data assessments.
  • Aseptic processing.
  • Experience with DP TT – Vial filling essential, PFC an added bonus.
  • Must have DP Technical Services/ Technical Transfer experience. Having been a lead in TT is preferable.

9613 - Project Engineer - Cork

Purpose:

The role of the Project Engineer is to Project Manage and Task Supervise Projects in the facility on behalf of the Engineering Department so that Projects are carried out in a compliant manner with all Site Procedures, Global Engineering standards and specifications. The role involves executing a large range of Projects from Facilities to Utilities and ensuring contractors perform and deliver to scheduled and budgeted expectations. Projects to be executed using our defined Project Execution Strategy. The incumbent will be responsible for ensuring there is a strong safety culture and performance in the execution of capital projects. The Project Engineer will report to the Engineering Projects Lead and will work closely with Area owners and Permit issuers. They will ensure all RAMS and Permits are correctly populated and approved for Project Works.

 

Responsibilities:

  • Develop project plans and successfully execute them according to established schedule, cost and performance standards.
  • Track and report progress by issuing regular Scorecards and Schedule updates.
  • Ensure accountability of all project personnel on responsible projects
  • Manage design, construction, commissioning and qualification, schedule and cost in collaboration with other project team members, operations personnel, outside contractors and suppliers.
  • Take an active part in the evaluation and selection of external partners such as engineering consultants and contractors. Collaborate with and manage external consultants and contractors in building projects to ensure that project tasks and deliverables are being achieved.
  • Liaise with Area Owners to ensure operational requirements are included in all Project related interruption and outages.
  • Liaise with key stakeholders and ensure buy in up front on project requirements and impact on stakeholders dept/ area during and after execution.
  • Follow site Project Execution guidance standard and Portfolio Management Office tools and templates as required.
  • Generate Handover criteria for customers and ensure that Project Handover files are received and filed per company requirements.
  • Develop Charters with Customers for approval.
  • Create MOC, SOW, URS and RFC documents for Projects.
  • Manage Enablon’s and close in a timely manner.
  • Ensure the maintainability of new and modified installations.
  • Ensure all work is conducted within EHS guidelines and standards and all works conforms to Company’s EHS policy.
  • Act as company POC for OEP run Projects and support other programs on site as required.
  • Manage costs by forecasting and monitoring spend on projects.
  • Create Snag lists and ensure Projects are completed to a high standard of Quality.

 

Minimum Qualifications and Experience:

  • Degree or 3rd Level Qualification (Engineering.)
  • 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.
  • Desirable to have qualification in Project Management.
  • 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.

 

9621 - Business Consultant - Dublin

Purpose:

The site Knowledge Management (KM) Site Lead will help unlock & retain site knowledge for business continuity and enable the flow of critical knowledge for products and processes (technical and business) within the site as well as between key partners and organization. The KM Site Lead will leverage the KM CoE to help identify site needs and opportunities to improve and promote knowledge flow with a focus on key products and processes that enabler product realization activities, from commercialization, launch, & supply (e.g. capture of tacit knowledge, technology transfers, investigations, etc.)

 

Responsibilities:

  • Leverage company KM strategic imperatives to ensure site knowledge is managed as an asset for business continuity, foster collaboration, ensure connectivity and enable the greatest value from project and site knowledge.
  • Champion knowledge flow within the site and across other sites in the supply chain that manufacture the key products of the site. KM CoE will support and enable with training, coaching, standard work, tools, techniques, templates, guides and other assets. The OpU KM Business Partner will be a key linkage to the KM CoE.
  • The KM Site Lead will be an active member of a KM practitioner community with leads from other sites and functions and have the opportunity to partner in development of new KM capabilities at a regional or global level. The individual will be engaged with the full KM community across the company network, gaining insights about other sites, functions and leadership.
  • Partner with site leadership team members and their respective teams to evaluate and identify areas of opportunity/gaps in knowledge flow (pain points) for prioritized areas , leveraging assessments and knowledge mapping as appropriate.
  • Develop and maintain the site KM plan that links to the site Hoshin, objective and Operating Units KM focus areas.
  • Lead deployment of the site KM plan, as linked to the site objective and priorities.
  • Measure progress against the site KM plan. Gather, monitor and report progress of KM initiatives to site and KM CoE leadership with metrics.
  • Serve as the site KM SME and lead KM practitioner providing the following:
    • After Action Review (AAR) facilitation as a certified AAR practitioner.
    • Knowledge mapping.
    • Training for KM Tools TK, Take 5, Vitual Talent Network and any other standard KM tools.
  • Support the design, implementation, and enhancement of core KM approaches used to support capture and share critical knowledge flowing critical knowledge flow within key site business processes and between the site and global organizations supporting the commissioning, qualification and filing.
  • Ensure site content is managed in a way to allow site personnel to find and utilize knowledge in an efficient manner.
  • Responsible for deployment of new KM capabilities at the site and determines where core KM capabilities should be deployed, utilized and leveraged to business benefit.
  • Provide valuable feedback to the KM CoE on KM business impacts and contributes to next generation solutions through participation on benchmarking activities.

 

Minimum Qualifications and Experience:

  • Bachelor’s degree in a Science or Engineering discipline.
  • Desirable to have a Masters in a related discipline.
  • A minimum of 5 years experience working on a biopharmaceutical manufacturing site.
  • Evidence of Continuous Personal Development.
  • Desirable: Six Sigma Green Belt.
  • Demonstrated ability to design and facilitate workshops, meetings, and/or large or small groups to drive successful outcomes.
  • Clear understanding of business situation and processes, and can map processes as required, and good working knowledge of organizational and business strategy.
  • Ability to contract with and influence leaders in the organization, good at networking, collaboration and sharing of ideas and success.
  • Ability to elicit requirements and anticipate customer needs, at both operational and strategic levels, and ability to deliver solutions that meet or exceed customer expectations.
  • Ability to think strategically for long term vision and in terms of culture, behavior, business processes and tools yet can meet tactical needs and tailor solutions to be fit-for-purpose.
  • Creative, innovative, self-motivated, applies problem-solving skills (thinks outside of the box) and systems thinking skills.
  • Has a understanding of KM principles and first-hand experience in KM techniques desirable, such as professional networking / social media; taxonomies; expertise location; best practices transfer; lessons learned; and other common processes.
  • Understanding of Lean diagnostics techniques including SIPOC and process mapping to elicit customer requirements and design solutions to meet these requirements.
  • Understanding of pharmaceutical product lifecycle phases including typical types of product and process knowledge. Experience generating or managing product and process knowledge in the commercialization / product manufacturing lifecycle phase of pharmaceutical manufacturing is desired.

 

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.

 

9521 - Senior Project Engineer - Cork

Purpose:

A vacancy exists within our Global Engineering Solutions (GES) group for a Client side Senior Project Engineer (Utilities Clean & Black) supporting GES capital projects in Ireland. A high level of initiative, energy and motivation are key role requirements, as well as excellent organizational skills. The successful candidate will have several years’ experience working in the pharmaceutical or similar Industry. Reporting to the GES Associate Director – Project Management based at the Site. The Engineer will have previous significant experience at a senior level within a >€100MM Project.

 

Responsibilities:

  • Ensure there is a strong safety culture and performance in the design and execution of capital projects.
  • Manages a specific scope of the project to ensure that the performance, cost & schedule criteria are met.
  • Ensure that partners (EPCM & Vendors) are performing to meet the needs of the project and escalating issues if not resolved.
  • Manages inputs to the assigned project scope of the stakeholders ensuring they are informed and consulted on key project activities, progress and decisions.
  • Ensures that key issues/escalations and decisions and backup to same are made visible and are logged appropriately.
  • Liaise with Appointed EPCM to assist with the Management of design, construction, commissioning and qualification, schedule and cost control in collaboration with other project team members, Site personnel, outside contractors and suppliers.
  • Manage capital spend on assigned project scope – engage in estimation to forecasting to financial close-out ensuring a continual focus on cost awareness.
  • Monitor progress of project milestones with all team members and provide status reports.
  • 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 for Quality / Safety / Cost or schedule impacts.
  • Coordinate with EPCM the generation and execution of Commissioning & Qualification documentation.
  • Client inputs to the planning of critical fieldworks for vendor engineers and contractors
  • Participate in EPCM led HAZOP and design reviews as lead GES Representative, ensuring 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 Biopharma environment.
  • Have SME knowledge of utilities systems (both Clean and Black) and general knowledge and experience of bio-pharma drug product facilities.
  • Preferable to have a qualification in project management – PMP or equivalent.
  • Proven level of experience in being a senior member of a team delivering significant capital projects >€100MM.
  • Ability to coordinate activities to deliver projects to an aggressive schedule.
  • Experience of clean room installations essential.
  • 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.
  • Demonstrated performance and managing multi-functional teams.
  • Demonstrated experience in leading projects from Design to Qualification.
  • Black Utilities Design – Commissionning.
  • Clean Utilities Design – Qualification.
  • Clean Room facility design.
  • Facilities & HVAC Design including BMS.
  • Construction Management.
  • Project Controls.

 

9520 - Warehouse and Logistics Program Lead - Cork

Purpose:

Lead the portfolio of projects for the Warehouse and Logistics function at the facility. The scope of projects entails working closely with the Operation IPTs projects, SAP Implementation team and new Projects for Warehouse and Logistics, whilst ensuring timely delivery of project milestones and ensuring no disruption to current business. The Project Manager will participate and comply with the Quality Management System (QMS) requirements, including ownership, as relevant to you.

Responsibilities:

  • Facilitating the definition of project scope, goals and deliverables.
  • Creating and executing and revising project work plans as appropriate to meet changing needs and requirements.
  • Managing day-to-day project aspects and tracking deliverables.
  • Identifying resources needed and assigning individual responsibilities in matrix team.
  • Lead a Matrix team, a key role that provides direction and support to project team.
  • Effectively applying methodology and enforcing project standards.
  • Holding regular status meetings with project team and effectively communicating relevant project information to stakeholders.
  • Resolving and/or escalating issues in a timely fashion.
  • Ensuring project documents are complete, current, and stored appropriately.
  • Responsible for supporting a culture of Continuous Improvement by deploying Six Sigma / MPS tools in Hoshin Kanri, Project Portfolio Management, Supply Risk Reduction and site processes.

 

Minimum Qualifications and Experience:

  • Degree or 3rd level qualification (Business, Supply Chain, Science or Engineering.)
  • At least 3 years’ experience in the Pharmaceutical industry or a similar operating environment which includes significant project leadership roles with experience in a matrix structures.
  • Demonstrated knowledge in more than one pharmaceutical and/or chemical manufacturing operation (e.g. Manufacturing, Quality, Engineering, etc.)
  • Knowledge of and experience in applying Six Sigma and Lean methodologies.
  • Desirable Project Management qualification such as, Project Management Professional.
  • Preference Lean Six Sigma Green Belt.
  • Evidence of Continuous Professional Development.
  • Professional qualification / business and number of years warehouse/Logistics experiencing in similar environment.

 

8545 - Compliance Specialist - Carlow

Responsibilities:

  • Supports project management team from design to financial closeout.
  • Is knowledgeable of construction industry risks and current events.
  • Reviews, verifies, and analyzes information related to construction project activities.
  • Creates and maintains audit work papers.
  • Understands Contract Scope, terms and conditions, and applies to downstream processes such as Change Management and Invoicing.
  • Makes recommendations for best practices.
  • Provides audit management with recommendations on audit scope.
  • Responds to internal and external customers as needed in a service oriented manner.
  • Consolidates results and recommendations in audit database repository, and follows-up on status.
  • Communicates, in a timely manner, with responsible Project Team members.

 

Minimum Qualifications and Experience:

  • Degree in Accounting, Engineering, Finance, or other relevant discipline.. Experience 5+ of 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).
  • Excellent analytical and communication (verbal, written) skills. Proficient in Microsoft Word and Excel.
  • SAP work experience strongly preferred.

 

9126 - Senior Process Engineer - Cork

Purpose:

Provide process engineering services in support of the design, construction, commissioning and qualification of a Sterile Formulation and Filling Facility. The job-holder works with the company Process Engineering Team to act as client owner representative to deliver integrated process engineering services to meet the Project Objectives. The Senior Process Engineer will manage cross functional teams to deliver a significant suite or multiple suites of related process scope.

 

Responsibilities:

  • Support GES Process Lead to implement a Process Design based on the scope of Process Requirements provided by the Technology and Manufacturing owners.
  • 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.
    • Monitor progress of process suite team milestones with all team members and provide status reports to project Tiers and stakeholders.
  • Act as client owner representative to self-execute critical design deliverables and provide direction & oversee design progression by an Architect & Engineering design firm.
    • Develop Process Flow Diagrams, P&IDs, User Requirement Specifications and Equipment Specifications to ensure Process Descriptions/Needs are met.
    • Manage team to complete process safety deliverables including PHA (Hazops.)
    • Ensure the company’s Global and Carlow site engineering standards, procedures and practices are followed in the design development.
  • Support GES C&Q Lead to coordinate preparation and lead FATs/C&Q field execution.
    • Develop and/or review system lifecycle documents including Criticality and Risk assessments, FAT documentation, and C&Q documentation.
    • 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 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 sterile or aseptic manufacturing.
  • Minimum of 8 years post academic process engineering experience in relevant aseptic/sterile processing design, construction & start-up environment.
  • In depth understanding of process engineering and technologies pertinent to unit operations including Closed-Process Formulation, Depyrogenation Tunnel, Isolated Filling, Capping, Automated Parts Washing, Autoclave Sterilization, Mobile Process Vessels, Bioburden reduction/Sterile Filtration, and CIP/SIP.
  • Knowledge on the application of Disposable Technologies.
  • Knowledge of PLC process control platforms and industry SDLC methodology.
  • The role will require periods of travel to support vendor reviews & FATs, and periodic attendance at Architect & Engineering Firm offices (location TBD). Flexibility is required in this regard.

 

9429 - C&Q Senior Specialist - Cork

Purpose:

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

 

Responsibilities:

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

 

Minimum Qualifications and Experience:

  • Bachelor of Engineering or Science Degree in Engineering or Technology related discipline.
  • Minimum of 3 years’ experience in commissioning and/or validation of Drug Product Facilities/Utilities systems within Pharmaceutical industry.
  • Technical knowledge of black utilities and clean utilities systems and equipment, biotechnology processes and a working knowledge of FDA and EU regulations is preferred.
  • Previous experience working with the company will be advantageous
  • Experience in C&Q of Drug Product Facility
  • Working knowledge of process control systems and automation. DeltaV, syringe & vial line experience beneficial.
  • Knowledge of C&Q documentation required for cGMP process equipment.
  • Working knowledge of word processing, spreadsheets, database management software, CAD software, and PCs.
  • Knowledge of regulations and standards affecting devices, biologics and pharma products.
  • Knowledgeable with latest industry standards and guidelines on C&Q, including ISPE/ASTM
  • Implement company GES C&Q strategies as set out by the C&Q Technical Lead.
  • Ensure that system delivery progresses in accordance with the approved project schedule.
  • Notify C&Q Technical Lead, in a timely manner, of all relevant issues which may impact on system progress.
  • Ability to work in design and construction project environment within Ireland.
  • Coordinate with design and/or project teams to resolve any identified technical issues.
  • Organise/attend all coordination meetings necessary to progress the job.
  • Ensure that all works carried out in C&Q scope or responsibility by construction, commissioning and contract team members are performed in accordance with site safe working practices.

 

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.

 

9035 - Project Manager - Tipperary

Purpose:

A vacancy exists within our Global Engineering Solutions (GES) group for a Senior Project Engineer supporting GES capital projects in Tipperary. Reporting to the Global Engineering Solutions Project Manager based at the Tipperary Site. 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 clean utilities, black utilities & cleanroom design.
  • 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:

  • A minimum of 8 years of relevant experience in project management of capital projects in a high tech industry, preferably in Pharm/Bio Pharm.
  • Must have as a minimum a 3rd level Degree in Engineering, preferably Chemical or Mechanical
  • Preferable to have a qualification in project management – PMP or equivalent
  • Proven level of experience in delivering significant capital projects within the pharmaceutical sector.
  • 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
  • Demonstrated performance and managing multi-functional teams.
  • Demonstrated experience in leading projects from Design to Qualification.

 

9493 - Process Support Specialist - Carlow

Purpose:

Responsible for generating and expediting review and approval processes for IPT GMP documentation including but not limited to Quality Notifications, CAPA close out records, IPT Standard Operating Procedures and Standard Work Instructions and change controls. Ensure that objectives are effectively achieved, consistent with company requirements to ensure compliance, safety and reliable supply to our customers.

 

Responsibilities:

  • Support manufacturing activities through documentation generation, equipment and process investigations associated with non-GMP activities and completion of quality notifications. Provide input to the MES development process team on technical aspects of MES functionality and serve as MES SME within IPT.
  • Be a document system expert; this will include document review, approval and document system work flow expedition. Format, write, deliver and review necessary documentation in line with the standard approval process, and facilitate others to do so. Documents will include SOP’s, SWI’s, training documents, and change controls.
  • Support operation activities through documentation generation, filing, tracking, auditing and efficient maintenance of all associated databases including the maintenance, auditing and archiving of the process documentation system.
  • Support Batch release through timely Quality Notification completion, Interim/summary report generation; meeting batch release requirements.
  • Raise CAPA’s and conduct investigations. Raise and investigate quality notifications using standard tools and methods, to resolve system issues e.g. FMEA, Fishbone diagrams, 5 why’s etc.; implement subsequent corrective action through the change management system.
  • Complete Customer complaint investigations and Change Controls and ensure they are closed out to support production activities in a timely manner in conjunction with the SCM team.
  • Required to comply with company Global Policies, Procedures and Guidelines, regulatory requirements and execute current Good manufacturing Practices (cGMP) in the performance of day to day activities and all applicable job functions.
  • Work collaboratively to drive a safe and compliant culture in Carlow.
  • May be required to perform other duties as assigned.
  • Assist in the management and/or assignment of IPT training if required.

 

Minimum Qualifications and Experience:

  • Bachelor’s Degree or higher preferred; ideally in a Science, Engineering or other Technical discipline.
  • Relevant experience and a particular skill set in their area of expertise that adds value to the business; ideally in a manufacturing, preferably GMP setting.
  • SAP knowledge and experience required.
  • Proficiency in Microsoft Office and job related computer applications required.
  • Knowledge of regulatory/code requirements to Irish, European and International Codes, Standards and Practices.
  • Report, standards, policy writing skills required.
  • Equipment and process validation.
  • Sterile filling processes and equipment.
  • Lean Six Sigma Methodology experience desired.
  • Understand the specific responsibilities of all Carlow departments as they relate to ones own department, understanding the business processes ones department supports.
  • Excellent training, facilitation and assessment skills.
  • Risk management skills.
  • Strategy planning and development.
  • Demonstrable analytical and systematic problem-solving skills.
  • Strong influencing skills.
  • Flexible approach.
  • Focus on Customers and Patients.

 

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

 

9049 - Process Engineer - Carlow

Purpose:

Provide process engineering services in support of the design, construction, commissioning and qualification of a Sterile Formulation and Filling Facility. 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 assist in the management cross functional teams to deliver a significant suite or multiple suites of related process scope.

 

Responsibilities:

  • Support GES Process Lead to implement a Process Design based on the scope of Process Requirements provided by the Technology and Manufacturing owners.
  • Support cross-functional project teams to ensure project and site stakeholder inputs and requirements are clear and reflected in design deliverables.
  • Ensure all project stakeholders are informed and consulted on key process suite activities and decisions.
  • Monitor progress of process suite team milestones with all team members and provide status reports to project Tiers and stakeholders.
  • Support the Architect & Engineering design firm to:
  • Develop Process Flow Diagrams, P&IDs, User Requirement Specifications and Equipment Specifications to ensure Process Descriptions/Needs are met.
  • Support process safety deliverables including PHA (Hazops).
  • Ensure the company and their Carlow site engineering standards, procedures and practices are followed in the design development.
  • Support GES C&Q Lead to coordinate preparation and lead FATs/C&Q field execution.
  • Develop and/or review system lifecycle documents including Criticality and Risk assessments, FAT documentation, and C&Q documentation.
  • Support installation / start-up / testing of process systems through OQ completion. Interface with cross-functional team to ensure systems’ post-OQ (PQ, PPQ) readiness.
  • 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 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 sterile or aseptic manufacturing.
  • Minimum of 3 years post academic process engineering experience in relevant aseptic/sterile processing design, construction & start-up environment.
  • Understanding of process engineering and technologies pertinent to unit operations including Closed-Process Formulation, Depyrogenation Tunnel, E-Beam, Isolated Filling, Capping, Bioburden reduction/Sterile Filtration, and CIP/SIP is an advantage
  • The role will require periods of travel to support vendor reviews & FATs, and periodic attendance at Architect & Engineering Firm offices (Cork). Flexibility is required in this regard.

 

8147 - QA IT Specialist - Carlow

Purpose:

The successful candidate will provide QA IT oversight and support for the site computerised systems to ensure compliance with regulatory expectations and company Computer Systems Validation (CSV), System Development Lifecycle (SDLC), Cyber Security and Data Integrity requirements. This will include supporting implementation of new automated equipment and a DCS on a key site project.

 

Responsibilities:

  • Providing independent quality review and approval of system lifecycle documentation, such as plans, requirements, risk assessments, protocols and reports.
  • Providing independent quality review and approval of system changes.
  • Supporting and approving computerised systems investigations and deviations.
  • Ensuring consistent approach to qualification, change and deviation management across systems.
  • Providing timely and pro-active QA IT support and guidance to facilitate project timelines.

 

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 experience will be an advantage

 

 

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.

 

9376509 - Technical Specialist - Dublin

Purpose:

The Purification (Downstream) Technical Specialist has primary responsibility in supporting the cGMP manufacture of biological bulk drug substance (BDS) as part of the Technical Services Team at the company’s facility in Dublin. The Technical Specialist will provide protein purification processing expertise to support the facility design, start-up and routine commercial manufacturing for chromatography, UFDF/TFF filtration, Viral filtration technologies and bulk fill unit operations 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, DS Process Sending unit, Operations, Engineering, Supply Chain, Quality, Quality Control, Regulatory and other involved departments to ensure successful facility start-up and process qualification (PPQ). The position is accountable for timely completion of technical transfer related milestones, with particular emphasis on new product introduction, Process Owner for purification unit operations, Process Validation (PPQ), Process Monitoring, Risk Assessment (using QRM tools), and building strategies / SME capability.

 

Responsibilities:

  • To provide process expertise in the area of buffer preparation, large scale protein purification drug substance manufacturing process (column chromatography, VI, UFDF/TFF, Viral filtration and bulk fill) to support the successful startup of the company’s BDS facility in Dublin.
  • Working knowledge of typical chromatography and filtration unit operations and functional purpose, cause and effect, in-process tests, and mass balance principles.
  • To author and review process transfer documentation, gap assessments, technical protocols and reports, including process validation documentation & strategy documents.
  • To identify requirements for laboratory studies to support process fit, decisions or process transfer, and to liaise closely with Global Process Development to input to the design/ execution of studies.
  • To support the introduction of new raw materials and consumables through the generation of materials lists, Bills of Materials, material specifications and outline testing requirements.
  • 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.
  • To identify and implement process and continual improvements; e.g. yield, cycle time reduction etc.
  • To generate documentation protocols and lead the execution of 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 required, and participation in on-call roster.
  • To provide on the floor support for troubleshooting processing issues and to lead manufacturing investigations into process deviations and resolution with CAPAs.
  • Lead any key process changes using change control management system.
  • 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.
  • To author and review IND, BLA and other technical documents for regulatory agency submissions.
  • To serve as a subject-matter expert (SME) on technology transfer and process unit operations support during regulatory agency inspections.

 

Minimum Qualifications and Experience:

  • Minimum requirement would be B.Sc. in Biochemistry, Biology, Chemistry or equivalent, or Eng. Process or Chemical Engineering. A higher degree (M.Sc. or Ph.D.) would be an advantage
  • Minimum 5 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 downstream protein purification processing (chromatography, filtration, TFF).
  • In-depth technical and operational knowledge of multiple unit operations in downstream processing, including buffer preparation, industrial scale protein purification, TFF filtration, final fill, nano and process filtration.
  • Strong understanding of technology transfer, scale-up process and cleaning validation.
  • Comprehensive understanding of cGMP requirements for clinical and 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 design, commissioning and start-up of a bulk drug substance facility would be beneficial.
  • 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
  • Comprehensive understanding of cGMP requirements for biopharmaceutical manufacturing.
  • Technical writing competency.
  • Experience of authoring CMC sections to support regulatory submissions would be advantageous.
  • Experience of Technology Transfer activities is advantageous.
  • Experience of disposable technology would be advantageous.
  • Knowledge or experience of start-up or systems would be ideal.

 

2019-260 - QC Specialist for LIMS - Meath

Description:

This role will support the Quality Control functional testing of incoming raw materials, in-process drug substance/drug product, final drug products, stability samples and environmental monitoring of the controlled manufacturing areas and utilities at the new single-use multi-product biotech facility. This facility will manufacture enzyme replacement and antibody-based therapies for a leading global biotech company focused on rare diseases. The overall responsibility for this role will be to support the Quality Control testing function, ensuring compliance with cGMP and corporate regulations. This is a critical role within the Quality organisation to help establish the Laboratories as a hub for specialised analytical testing and create value for our patients.

Responsibilities:

This role is associated with the data management systems for instrument control in the laboratories, this includes but is not limited to Labware LES (LIMS + Execution System), Lonza MoDa, Waters Empower, Mettler Lab-X. Below activities are associated with these systems;

  • Participates in defining user requirements.
  • Tests and validates the design.
  • Develops procedures and training documents.
  • Assist in the implementation at site.
  • Gather raw data for template building.
  • After vendor provided training will provide the first line of support within their laboratories.
  • Empower superuser to build and maintain custom calculation builds and system maintenance.
  • Reviewing analytical data, analytical reports and performing peer reviews.
  • Instrument qualification, maintenance and troubleshooting.
  • Protocol generation– method verification/transfer.
  • Providing training for team members.
  • Following all relevant Standard Operating Procedures.
  • Ensuring strict adherence to site policies, GMP and environmental, health and safety regulations.
  • Complies with all pertinent regulatory agency requirements.
  • Execution and on-time completion of required training activities.
  • Conducts thorough data review to ensure completeness and accuracy of records.
  • Reviews test results to ensure compliance with standards; reports any quality anomalies.
  • Participates in Laboratory Investigations as required.
  • Writes and revises control test procedures and SOPs as required.
  • May interact with outside customers or functional peer groups.
  • Promotes and exhibits company Values.
  • Executing company policies.
  • Ensuring self -inspections are performed.
  • Ensures new/revised quality system requirements are deployed to the Site

Minimum Qualifications and Experience:

  • A Level 8 Bachelor’s degree in a technical discipline (e.g. biochemistry, chemistry, engineering etc).
  • Previous GMP laboratory experience in the biotechnology and/or pharmaceutical industry.
  • Excellent communication skills (written and oral).
  • An understanding of cGMP requirements for manufacturing and/or systems and compliance.
  • Required to work on his/her own initiative in addition to working as part of a team.
  • Excellent time management & organisational skills.
  • An understanding in analytical methodology (e.g. HPLC, ELISA, SDS-Page, Glyco analytic, Bio- Assays, PCR, capillary electrophoresis, compendial assays).
  • A working understanding of GMP, ICH, USP and global compendia regulations and guidance’s, particularly as related to analytical method development and validation.
  • Previous experience with laboratory management systems such as LIMS/ MoDa/ Lab-X and / or Empower systems and interest in coding/ script.

Key Skills & Competencies:

  • Excellent trouble-shooting and problem-solving skills.
  • Ability to challenge the status quo with a continuous improvement mindset.
  • Promoting a culture where diversity and inclusion is part of the DNA.

Complexity & Problem Solving:

  • Identifying and communicating risks in area of responsibility and across the site.
  • Creating strategies and plans to manage risk within the Quality Control operation.

Internal and External Contacts:

  • For product quality, collaborates with Manufacturing, Science & Technology (MS&T) and Manufacturing Operations but is responsible for providing information to support the QMR decision.
  • For quality and compliance, collaborates with the QMR but accountable for creating a ‘right first time’ culture in the Quality group to support quality excellence.
  • For safety, the individual is accountable to drive a culture of ‘everyone owns safety’ with input from the EHS lead.
  • For continuous improvement collaborates with Business Excellence peers across the Biologics business unit in the company and through external forums to drive business excellence in Quality Assurance.

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