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

11870 – Process Engineer - Carlow

Purpose:

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

Responsibilities:

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

 

Minimum Qualifications and Experience:

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

 

 

11873 – CSV Engineer - Carlow

Purpose:

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

Responsibilities:

  • Develop and maintain Qualification Plans and Test Plans, aligned with the overall project C&Q plan and with the leveraging strategy.
  • Develop templates for all SDLC deliverables, compliant with company standards, to ensure consistent implementation of the validation strategy, including but not limited to:
    • Requirements Specification.
    • Requirements Traceability Matrix.
    • Functional Specification.
    • Design Specification.
    • Code Review.
    • Test specification/test script.
  • Work closely with the QAIT function and ensure their requirements are met in all deliverables.
  • Align with the company’s HPV program: leverage existing documents & expertise where feasible.
  • Approver of all AIT SDLC deliverables, ensuring compliance with standards.
  • Provide FAT oversight and perform leveraging assessments.
  • Provide guidance and support to AIT team members tasked with delivery of SDLC documents.
  • Provide input to the development of realistic project schedules and document trackers.
  • Work closely with suppliers / integrators to ensure compliance with company standards.
  • Participate in, and support, relevant project meetings.
  • Liaise with the various stakeholders on the overall project to ensure clear communication between all parties in relation to AIT validation requirements.

 

Minimum Qualifications and Experience:

  • Relevant Computer Science or Engineering degree or equivalent.
  • Minimum of 3 years’ experience in a similar role, ideally in the Pharmaceutical industry.
  • Fluent in English, written and verbal.
  • Expert knowledge of GAMP5.
  • Strong experience in one or all of the following systems: DeltaV, PCS7 (or other PLC/SCADA), 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.)

 

11871 – Automation Engineer - Carlow

Purpose:

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

Responsibilities:

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

 

Minimum Qualifications and Experience:

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

 

11872 – Automation Engineer - Carlow

Purpose:

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

Responsibilities:

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

 

Minimum Qualifications and Experience:

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

 

11586 – Electrical Instrumentation Engineer - Carlow

Purpose:

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

Responsibilities:

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

 

Minimum Qualifications and Experience:

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

 

11845 – Automation Engineer - Cork

Purpose:

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

Responsibilities:

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

 

Minimum Qualifications and Experience:

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

 

11855 – Training Specialist – Carlow

Purpose:

Responsible for the design, facilitation, implementation and optimization of site Training system, learning programs and training initiatives for the site. Ensure that objectives are effectively achieved, consistent with the company’s requirements to ensure compliance, safety and reliable supply to our customers.

Responsibilities:

  • Assess and prioritise training needs for the site (e.g. through consultation with L&D Lead, Global L&D Contact, managers/ system owners, and subject matter experts), with reference to the site’s strategic goals and Employee Development Plans.
  • Support managers and individuals by providing information, advice and resources in order to promote a high performing organisation. This includes design and delivery of customized training plans for new and existing employees.
  • Support and further develop the L&D Business partner model.
  • LMS System admin/ super user: Lead the day-to-day operation of the learning management system in compliance with site procedures. Ensure correct records retention for training records.
  • Provide guidance for the design of training programs and assist in evaluation of training activities.
  • Develop training content including materials and/or training aids required to deliver training programs.
  • Act as Sub System Owner (Business Process Owner) delegate (Chapter 3.1 Training and Qualification) and provide audit support for training system as required. Act as subject matter expert for the training system.
  • Work with relevant departments to prepare the Annual GMP and EHS training plans for the site.
  • Facilitate classroom and skills training as required.
  • Understand the specific responsibilities of all Carlow departments as they relate to one’s own department, understanding the business processes one’s department support.
  • Attending Global meetings as required.
  • Working with Global L&D and Implementing change.
  • Point of contact for Regulatory and Board of health Audits.
  • Subject matter expert.

 

Minimum Qualifications and Experience:

  • Diploma or higher preferred; ideally in a related discipline.
  • Minimum of 3 years’ experience.
  • Considerable experience and critical skills in their area of expertise that add value to the business; ideally in a Learning and Development setting preferably GMP setting.
  • Expert knowledge of principles and methods for design and delivery of training material.
  • Presentation skills.
  • Training evaluation skills.
  • Computer skills – Powerpoint, excel, Word, Project Management skills.
  • Understanding of Leadership behaviors.
  • Listening and Observation skills (self, other individuals, teams.)

 

10947337 – Quality Engineer - Dublin

Purpose:

A key contributor to the Quality Systems Improvement program on site to achieve ISO13485, 21CFR Part 4/820 and EUMDR compliance across the entire product lifecycle – from development to distribution. You will play a key part in leading the assessment, creation, and/or update of Standard Operating Procedures, work/testing instructions as the relate to the device and combination product Lifecyle to pre-defined project timelines.

Responsibilities:

  • Working with key stakeholders and within the QMS team, play a pivotal role in leading relevant departments in developing and implementing a Quality Management System based around ISO 13485, 21CFRPart4, and EUMDR.
  • Be the Subject Matter Expert regarding Acceptable Quality Standards for processes.
  • Support the company by helping review and approve necessary Procedures, Work Instructions, Forms and training.
  • To help develop a culture of continuous improvement within the Company.

 

Minimum Qualifications and Experience:

  • A degree in a relevant engineering, design or science discipline (or equivalent qualification.)
  • 4+ years’ experience in a highly regulated environment.
  • Appreciation for all stakeholders involved in new product development.
  • Developing and improving Quality Management Systems and the ability to interpret regulations.
  • Experience ensuring a high level of compliance with MDR, ISO 13485, 21 CFR 820, and cGMP.
  • Experience auditing to ISO 9001 or ISO 13485 would be an advantage.
  • Experience in product development and the application of Design Controls would be an advantage.
  • Bring demonstrable experience from within the Medical Device/ GMP / Regulated Industry.
  • You will be adept at assessing Quality Management System elements and their interdependencies.
  • You will be a natural communicator, whether this be written or verbal, and be comfortable working in a fast paced and dynamic environment.
  • Ability to lead and influence.

 

11379 – Supply Chain Specialist – Carlow

Purpose:

Responsible SAP Master Data and Material Management the site. SAP Master Data includes the creation, qualification, data analysis, data accuracy and change control for SAP Master Data, including but not limited to all objects, views and fields within the function. Material Management included the Administration and Co-ordination of the material introduction process at the site and the management of supplier change notifications and supplier complaints. Ensure that objectives are effectively achieved, consistent with the company’s requirements to ensure compliance, safety and reliable supply to our customers.

Responsibilities:

  • Responsible for ensuring that master data is accurate and up-to-date and meets the needs of all business processes including QM, MH, PE, FBM, Costing, OTC, Interstat and others as applicable.
  • SAP Master Data includes the creation, qualification, data analysis, data accuracy and change control for SAP Master Data, including but not limited to all objects, views and fields within the function. Analyzes data feeds and reconcile reports which are critical to daily operations.
  • Working independently, they will use SAP knowledge, business processes knowledge and SOP’s to correctly maintain master data. They will communicate and interact with buyer planners and other SAP Process Stewards to resolve issues regarding master data.
  • Ensures timely updates of master data creation, revision and obsolescence and completion of the applicable documentation.
  • Responsible for Management of BOMs, Recipes and Production versions in SAP and alignment with effective MBRs in MES system.
  • Responsible for completion of the Material introduction process at the site ensuring that all suppliers and materials are approved for use on site in compliance with site and Global procedures. This includes the creation and maintenance of Approved Material files including Material Specification and purchasing and distribution documentation as required. Assist in changes to existing materials or suppliers on site. This involves close collaboration with the Technical Engineering, IPT and Quality teams. Coordinates/facilitates the Material Review board Cross Functional Assessment team.
  • Responsible for the processing of supplier complaints, ensuring that they are raised investigated and closed in accordance with site and global procedures. This includes the resolution of the inventory associated with supplier complaint and requiring certificate of destruction / discards as required.
  • Responsible for ensuring SCN’s (Supplier Change notifications) are implemented in a timely manner to ensure all SCN’s are implemented, in accordance with site and global procedures, prior to affected materials being delivered to / used on site.
  • Participate in the Community of Practice and other above site initiatives to help drive business objectives. Stay well aligned with SAP global groups and with SAP counterparts at other company sites.
  • Ensure that objectives are effectively achieved, consistent with the company’s requirements to ensure compliance, safety and reliable supply to our customers.
  • Drive compliance with the company’s Global Policies, Procedures and Guidelines, regulatory requirements and execute current Good manufacturing Practices (cGMP) in the performance of day to day activities and all applicable job functions.
  • Drive continuous improvement by leading and active participation in system failure investigations and investigation reports, execution/development of change control, and contribution to Kaizen events as appropriate.
  • Manage root cause analysis of system failures, substandard equipment performance, using standard tools and methods, to resolve machine and system issues e.g. Fishbone diagrams, 5 why’s etc.; oversee and implement subsequent corrective action through the change management system.
  • Work collaboratively to drive a safe and compliant culture in Carlow.
  • May be required to perform other duties as assigned.

 

Minimum Qualifications and Experience:

  • Bachelor’s degree or higher preferred; ideally in a Science, Engineering or Other Technical discipline.
  • SAP Knowledge essential.
  • Use of Pro-Model essential.
  • Green Belt preferable.
  • Considerable experience in a comparable role; contributing to the business at a directional, strategic level; ideally in a manufacturing, preferably GMP setting.
  • Knowledge of regulatory/code requirements to Irish, European and International Codes, Standards and Practices.
  • Understanding of business and operations management models and their application.
  • In depth knowledge of SAP and master data and is knowledgeable on world class standing in this field.
  • Ability to complete investigations and excellent report writing skills.
  • Excellent use of Excel and generation of report / standards and policy writing skills required.
  • Lean Six Sigma Methodology experience desired.
  • Having a strong safety ethos.
  • Understand the specific responsibilities of all Carlow functions as they relate to one’s own department as well as the network governance groups.
  • Have shown the ability to effectively manage complex projects across multiple disciplines.
  • Demonstrate analytical and systematic problem-solving skills.
  • Effective conflict resolution & Negotiation skills.
  • Strategy planning and development.
  • Risk management skills.

 

11837 – C&Q Engineer - Cork

Purpose:

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

Responsibilities:

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

 

Minimum Qualifications and Experience:

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

 

11848 – Project Manager – Carlow

Purpose:

The True Grid Integration Management Office (IMO) is in the process of preparing and enhancing to integrate a new Biologics facility into the company. With your help we will ensure success by clearly defining and tracking the activities and/or steps required to meet our Integration, Technology Transfer and Manufacturing milestone dates. For this role, you will work with the company’s Integration Lead and the Core Integration teams to establish key IMO processes to facilitate transparency of planned integration activities across the Cross-Enterprise Process and Functional Integration Teams and also facilitate the Integration Meeting process that will underpin the integration. The Project Manager will report to the Integration Lead and will collaborate with all Integration functional team leads and with other stakeholders as needed.

Responsibilities:

  • Developing and maintaining exec level reports that will describe progress and status of the multiple workstreams that will underpin the integration.
  • Facilitate the weekly Integration meeting process (admin support will be provided for separately.)
  • Maintain an action register for the team.
  • Develop and maintain Integration Milestone Charts.
  • Be responsible for building the process, toolkits /checklists, and schedule required by the team to actively carryout a successful integration.
  • Lead and develop core planning meetings, with the necessary agenda, input and outputs.
  • Ensure effective planning, common understanding and delivery targets to achieve business requirements and incorporate data generated into the planning system.
  • Liaise across the integration sub teams to develop plans with a medium to long -term forward view and associated daily delivery plans.

 

Minimum Qualifications and Experience:

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

 

11843 – Health & Safety - Tipperary

Purpose:

An exceptional opportunity for an experienced S&E Specialist ideally with specialisation in Process Safety to join the Environmental Health & Safety team to support an exciting expansion project. In this position you will be primarily responsible for all aspects of the Project related EHS elements with a strong Process Safety Management program – you will be working with other S&E Specialists as SME’s and stakeholders. You will provide technical guidance to the project to ensure compliance with all relevant legal requirements related to Process Safety as well as our company’s corporate standards, policies, procedures and guidelines and industry best practices.

Responsibilities:

  • Participate in project design reviews and HAZOPS for proposed new systems.
  • Ensure management of change processes are followed and serve as EHS reviewer for planning of activities impacting existing facility operation.
  • Co-ordinate project support from relevant SME’s such as Industrial Hygiene, Process Safety, Machinery Safety etc.
  • Support the containment philosophy for the potent compound facility.
  • Serve as a site EHS representative during mechanical completion, commissioning and qualification activities, participate in project walk-downs and start-up activities for assigned systems:
    • Ensure that installation is in conformance with local and national regulations, internal company standards, design intent and HAZOP recommendations.
    • Ensure that all necessary procedures, PPE, signage and training are complete and available for performing the necessary tasks during the specific start-up phase.
    • Serve as primary EHS reviewer for Pre-Start-up Safety and Environmental checklists completed during project start-up activities.
  • Serve as a leader in demonstrating and implementing a strong EHS culture across the project.
  • Participation in the site Process Safety Relief Device sizing program as required.
  • Monitor developments and advice Management on changes in Process Safety/COMAH related Standards and Legislation.

 

Minimum Qualifications and Experience:

  • Bachelor’s degree in Chemical Engineering or Engineering or related Safety or Environmental field of study.
  • +5 years of EHS, Engineering, or Operational experience in chemical, pharmaceutical, biochemical, petrochemical or process related industry.
  • Knowledge of HAZOP, ATEX/EPD and Industrial Hygiene.
  • Drive to engage others and have excellent interpersonal, communication and leadership skills.
  • Ability to maintain focus on key project goals and priorities, but also analyse the detail to facilitate problem resolution and ensure project success.
  • Knowledge and experience working with EHS regulations.
  • Strong written and verbal communication skills.
  • Ability to influence both horizontally and vertically.
  • The successful candidate will be able to demonstrate a proven track record to influence others, have strong knowledge of safety programs and be a convincing communicator with strong interpersonal skills. The ideal candidate is a self-directed, technically strong individual who can work in a multi-functionary team environment.

 

10478143 - Process Development Scientist - Dublin

Purpose:

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

Responsibilities:

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

 

Minimum Qualifications and Experience:

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

 

11781 - Automation Engineer – Tipperary

Purpose:

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

Responsibilities:

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

 

Minimum Qualifications and Experience:

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

 

10785 - Quality Operations Deviation Quality Specialist - Dublin

Responsibilities:

  • Will serve as a Quality SME for site deviation management system.
  • Support the review and approval of site deviation and investigations reports.
  • Ensure root causes have been identified and corrective action implemented and can demonstrate basic knowledge of six sigma, LEAN, and root cause analysis tools used for identifying and correcting deviations.
  • Day to day management of Deviation and CAPA metrics.
  • Support internal and external audit preparations regarding deviation management system.
  • Support the delivery of site deviation training.
  • Support global meetings and activities for site deviation management system.
  • Works directly with cross-functional departments to ensure that quality system requirements are met.
  • Performs other duties assigned by Management.

 

Minimum Qualifications and Experience:

  • Bachelor’s degree (or higher) in Engineering, Chemistry, Biology, or relevant discipline.
  • This role requires a minimum of 3 years’ experience in, Quality Assurance,Technical Operations or Engineering within the Biopharma / Pharmceutical industry.
  • Must have at least 3 years of experience of deviation systems and investigations in a regulated environment.
  • Experience working in regulated environment with exposure in the Regulations & guidance’s – GMP, CGMP, GAMP, 21 CFR Part 11.
  • Must have experience of compiling and reporting QMS metrics.
  • Experience with SAP desirable.
  • Strong contemporary knowledge of relevant cGMPs, regulations and current industry trends relating to deviation investigations and CAPA identification.
  • Experience with new product introductions and/or process qualification/technology transfer.

 

10497462 – Technical Services Specialist - Dublin

Purpose:

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

Responsibilities:

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

 

Minimum Qualifications and Experience:

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

 

11731 – QA Compliance Specialist - Dublin

Purpose:

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

Responsibilities:

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

 

Minimum Qualifications and Experience:

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

 

11778 – CSV Engineer For Labs - Carlow

Purpose:

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

Responsibilities:

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

 

Minimum Qualifications and Experience:

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

 

11755 – Project Manager NON-IT - Cork

Purpose:

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

Responsibilities:

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

 

Minimum Qualifications and Experience:

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

 

2020-333 – Controls Engineer - Waterford

Purpose:

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

Responsibilities:

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

 

Minimum Qualifications and Experience:

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

 

2020-332 – Production Manager – Waterford City

Purpose:

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

Responsibilities:

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

 

Minimum Qualifications and Experience:

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

 

11415 – Laboratory Systems Specialist – Carlow

Purpose:

The QC systems specialist role will provide in-line technical support in relation to Laboratory Systems such as LIMS, Empower, SAP, instrument software and Data Integrity to ensure the continued manufacture and supply of quality pharmaceutical products meeting the company’s Manufacturing Division priorities of: Compliance, Supply, Strategy and Profit Plan. Ensure that objectives are effectively achieved, consistent with the company’s requirements to ensure compliance, safety and reliable supply to our customers. The Laboratory Systems specialist role acts as LIMS Site Administrator, Empower administrator and SAP (QM) master data maintainer for the site Laboratories and is required to be a subject matter expert in these areas. The role supports all internal customers including QC, QA, Automation and Operations. The role also supports external customers when required such as other company sites and Global functions. A high level of self-motivation, knowledge, enthusiasm and drive is required.

Responsibilities:

  • Provide efficient support to all departments at the facility including QC Microbiology, Quality Control and IPT for issues pertaining to LIMS, Empower and SAP, and to be a subject matter expert for these systems.
  • Deliver systems training to new hires and as additional roles are required for existing personnel.
  • Development and testing of systems master data. Perform new master data builds for the introduction of new products in line with analytical change control requirements to ensure the functionality is available in line with site schedule requirements.
  • Provide technical support to all users at the facility. Liaise with Global systems working groups.
  • Provide subject matter expertise in relation to Laboratory Systems. Works on improvement projects in relation to LIMS and other laboratory systems as required.
  • Actively identifies and progresses continuous improvement opportunities. Ensures strict adherence to site policies/procedure and good manufacturing practices.
  • Coach and guide colleagues onsite and in the network on the use of Laboratory Systems.
  • Leadership activities including selection, development, coaching and day to day management. Ensure that the team receives appropriate resources and programmes to develop technical and other skills, to complete their jobs whilst stimulating personal growth and development in line with role. Develop and maintain training programmes.
  • Required to comply with the company’s Global Policies, Procedures and Guidelines, regulatory requirements and execute current Good manufacturing Practices (cGMP) in the performance of day to day activities and all applicable job functions.
  • Performs assessments and provides overview of systems from a data integrity perspective ensuring the highest standards are maintained.
  • Work collaboratively to drive a safe and compliant culture in Carlow.
  • Lead Laboratory Projects for the Lab systems team.
  • May be required to perform other duties as assigned.

 

Minimum Qualifications and Experience:

  • Bachelors Degree or higher preferred; ideally in Science/IT or a closely related discipline
  • Considerable experience and critical skills in the area of expertise that add value to the business; ideally in Laboratory Systems setting. Preferably LIMS, Empower and SAP.
  • Knowledge of data integrity requirements required.
  • Change Management Skills (CEM) with continuous improvements.
  • Knowledge of cGMP and GDP preferred.
  • Proficiency in Microsoft Office and job related computer applications required.
  • Lean Six Sigma Methodology experience desired.
  • Occasional travel may be required.

 

 

10872 – Equipment Engineer - Dublin

Purpose:

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

Responsibilities:

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

 

Minimum Qualifications and Experience:

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

 

 

11738 – HR Business Partner - Dublin

Responsibilities:

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

 

Minimum Qualifications and Experience:

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

 

 

9934 – Process Engineer - Carlow

Purpose:

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

Responsibilities:

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

 

Minimum Qualifications and Experience:

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

 

 

2020-331 – Automation Engineer – Waterford City

Purpose:

To provide Automation and Equipment engineering support to site systems and process equipment and to ensure they are operated, improved and maintained to meet Customer and compliance requirements.

Responsibilities:

  • Automation Systems:
    • Facilitate internal resources and outside vendors in developing technical solutions for automated equipment. Interface with equipment vendors to ensure successful equipment delivery, integration and validation.
    • Maintain PLC automation systems in a validated state in compliance with site change control.
    • Understand the requirements of computer systems validation and ensure compliance is maintained.
    • Act as operations support for Fill Finish and Oral Dose facilities.
    • Interface with Operations, IT, QS and QA groups to successfully validate software systems and adherence to life cycle management and system maintenance.
    • Provide automation requirements and implement solutions for new products and/or capacity expansions.
    • Support disaster recovery and back up procedures and processes to ensure business impact is minimized in the event of a failure.
    • Provide technical and automation core competency support, including possible off-hours, remote and onsite coverage. This also includes operations / engineering training on basic troubleshooting.
    • Management of Automation vendors during equipment troubleshooting and upgrade activities.
  • Health, Safety & the Environment;
    • Comply at all times with the Health, Safety and Environmental policy and associated procedures.
    • Continuously promote a positive safety culture by challenging yourself and others to prioritize safety in everything you do.
  • Quality Compliance;
    • Ensure all work carried out, is in compliance with the required standards, conforming to company, cGMP, cGLP, SOP’s and regulatory guidelines.
    • Take ownership for quality compliance in all activities you are responsible for.

 

Minimum Qualifications and Experience:

  • Engineering degree in Electronics, Electro-mechanical or equivalent training/experience.
  • Minimum of 5 year’s engineering experience within Pharma Industry.
  • Experience with Siemens S7 PLCs and WinCC flexible desirable.
  • Experience with Fill Finish equipment required.
  • Experience working in a cGMP/FDA/HPRA regulated environment.
  • Experience with Industrial Ethernet and Scada systems.

 

 

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.

 

10489935 – QA Admin - Dublin

Purpose:

The Senior Administrative Assistant of Global Quality will support the Quality department.

Responsibilities:

  • Schedule meetings, manage inbox and manage calendars. Handle day to day administrative responsibilities.
  • Preparation of complex, ever changing international and domestic travel arrangements; including: booking flights, accommodation, car service, arranging meetings and preparation of itineraries.
  • Liaise with Quality Leadership Team and their staff to coordinate activities and meetings around the globe.
  • Partner with Site Leadership Team at College Park to ensure smooth coordination and execution of executive visitors to the site.
  • Producing spreadsheets and presentations in Excel and PowerPoint.
  • Handle extremely confidential and proprietary information with utmost discretion.
  • Act as gatekeeper, screening phone calls, responding or delegating to insure timely response.
  • Coordinate both small and large meetings, conference calls and global video conferences including advanced preparation of materials and audio/visual facilities.
  • Arrange visitors travel plans as required.
  • Process invoices and expenses ensuring all are paid on time while adhering to strict compliance guidelines, play a key role in budget tracking.
  • Open and manage Purchase Orders in SAP.
  • Mailing, tracking and documenting confidential documents and tax returns.
  • Responsible for filing, copying, scanning and faxing.
  • Assist audit inspection preparations and training administration.
  • Other duties as assigned.

 

Minimum Qualifications and Experience:

  • Diploma in Business Studies or equivalent.
  • Minimum of five years’ experience.

 

 

11725 – Senior Finance Specialist - Dublin

Purpose:

Reporting to the Site Finance Lead, you will work with the Finance team and Operational areas to support the analysis and development of the financial information required to successfully support the company’s endeavors. You will work with people at all levels of the organization to develop, report, monitor and manage key financial and non-financial performance indicators.

Responsibilities:

  • Set-up of finance systems and processes at this new site in line with corporate strategy and policies.
  • Develop & embed the finance performance metrics within the business and being accountable for analysis & commentary.
  • Coordinate the preparation of the annual budget cycle, quarterly forecast and capital budget submissions to achieve corporate deadlines and ensure divisional targets are met.
  • Planning, Monitoring and Controlling site spending – driving the competitive agenda on site.
  • Liaise with all site managers and department heads on their budget spending and headcount, providing detailed commentary on variances and addressing over-runs.
  • Monthly closing and reporting including the provision of accurate, timely and reliable financial information.
  • Lead the preparation of R&D Tax Credits submissions and Government Grants claims.
  • Preparation of standard costs and monitor / forecast all manufacturing variances to plan.
  • Promote and maintain focus on site cost saving initiatives. Regular reporting required on same.
  • Drive continuous process optimization, standardization and stability.
  • Contribute to site management operational and strategic initiatives e.g. costing new products / initiatives.
  • Responsible for driving a culture of Continuous Improvement by deploying company Six Sigma tools.
  • Develop, implement and monitor internal financial controls and procedures of the company and facilitate both internal and external audits including SOX compliance.
  • Work with the leadership team and partners in GES (Global Engineering Services) and MSDC (Manufacturing Systems Design & Commercialization) to support the capital investment at this strategic site.
  • Actively contribute as a member of the Manufacturing Division Finance Team on cross-site finance process and system improvement projects, manufacturing productivity and staff training and development.

 

 

Minimum Qualifications and Experience:

  • Degree or 3rd level qualification (Finance/Accounting.)
  • Accountancy Qualification essential.
  • At least 5 years of experience in the Pharmaceutical industry or a similar operating environment.
  • Knowledge of and experience in applying Six Sigma and Lean methodologies with a continuous improvement focus.
  • Experience in planning, budget and forecasting processes.
  • Understanding of inventory accounting and manufacturing variances.
  • Knowledge of SAP preferable.
  • Knowledge of MS Office products, including Excel, Word and PowerPoint.
  • Experience in supporting major capital expenditure/start-up projects.
  • Experience in preparing applications for Irish grants, subsidies, tax incentives.
  • Strong analytical skills.
  • Ability to prioritise tasks and work to tight deadlines.

 

 

11586 – Instrumentation Engineer - Carlow

Responsibilities:

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

 

Minimum Qualifications and Experience:

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

 

 

11585 – Utilities Engineer - Carlow

Responsibilities:

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

 

Minimum Qualifications and Experience:

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

 

 

11563 – Quality Specialist - Cork

Purpose:

The Quality Specialist will provide Quality oversight, support and expertise to GMP related activities and Quality Systems in the Integrated Process Team (IPT) and in meeting the company Manufacturing Division Priorities of: Compliance, Supply, Strategy and Profit Plan. The team working style is one of collaboration, coaching and facilitation to ensure the success of the site. The Quality Specialist will provide support to Operational Quality in the IPT and across site (as required.)

Responsibilities:

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

 

Minimum Qualifications and Experience:

  • 1 – 3 years’ experience in the Pharmaceutical, Biopharmaceuticals industry or a similar operating environment which includes experience in a Quality function.
  • Makes decisions within guidelines and policies which impact own priorities and allocation of time to meet deadlines.
  • Operational experience of at least 4 QMSs.
  • Degree in Science, Engineering or similar.
  • Lean Six Sigma Yellow Belt or suitable alternative.
  • Demonstrated use of Leadership Behaviours.
  • Quality Assurance knowledge, from both operational and educational experience.
  • Knowledge and experience in interpreting current regulatory requirements and providing independent support to the site.
  • Demonstrated ability to work independently and fully realize improvement initiatives with a moderate level of guidance.
  • Good communication, interpersonal skills and ability to work across teams.
  • Demonstrated ability to drive the completion of tasks.
  • Proven decision-making capability with accountability and responsibility.
  • Demonstrated ability to solve problems.

 

 

11153 – QC Instrumentation Specialist - Dublin

Purpose:

The role of the Quality Control (QC) System Specialist will provide quality support and expertise to the QC laboratory and ensure supply of quality pharmaceutical products in meeting the Manufacturing Division priorities of: Compliance, Supply, Strategy and Profit plan. The team working style is one of collaboration, coaching and facilitating to provide Quality oversight and expertise to the laboratory team to support a High Performing Organisation. Our Quality Control group ensures every single material inside our products is manufactured, processed, tested, packaged, stored and distributed aligned with our incredibly high standards of quality and meets all regulatory requirements. Partnering across our internal manufacturing facilities, external contract manufacturers and suppliers we create an interdependent global manufacturing network committed to deliver a compliant, reliable supply to customers and patients on time, every time, across the globe.

Responsibilities:

  • The QC System Specialist assures compliance with all safety and environmental requirements.
  • The QC System Specialist delivers a robust Quality Management System such as Waters© Empower and Labware© Global Laboratory Information Management System (GLIMS) to support a flexible, collaborate, multi-skilled teamwork environment.
  • The QC System Specialist completes System activities such as :
    • Raw Material / Excipient updates based of Quality System Changes requests.
    • Drug Substance / Drug Product updates based of Quality System Changes requests.
    • In Process / Cleaning Validation key changes updates to meet campaign start up deadline.
    • Addition of any new products/processes/raw materials for Drug Substance / Drug Product.
    • Manages projects relating to the upgrade or replacement of the current systems and directly co-ordinates the activities with managers and personnel in all the areas.
  • The QC System Specialist updates Global Laboratory Information Management System (GLIMS) or Empower for all changes and addition of new requirements.
  • The QC System Specialist reviews and approves key system quality deliverables including GLIMS reports, Change control on trackwise, deviations (DNs) and CAPAs in SAP.
  • The QC System Specialist ensures that all system activities comply with cGMP, including acting as auditee for CQAC/Regulatory Bodies /third parties site inspection.
  • The QC System Specialist provides second person review support for team members system documents to source documents to ensure accuracy, compliance, integrity, completeness, and traceability of each document.
  • The QC System Specialist authors or revises standard operating procedures and System Guidelines.
  • The QC System Specialist is responsible for making decisions within guidelines and policies which impact System QC projects.
  • The QC System Specialist operates as part of self-directed team in carrying out day to day function and assigning priorities.
  • The QC System Specialist participates in departmental initiatives on improved compliance and quality systems.

 

Minimum Qualifications and Experience:

  • At least a bachelor’s degree in chemistry, biological science, pharmacy, or related science field.
  • Minimum five (5) years’ experience in laboratory, technical services, and/or quality position required.
  • Experience in Static / Method Build in Waters© Empower and Labware© LIMS .
  • Working knowledge of biologics analytical methods and specifications and Good Manufacturing Practice (GMP).
  • Strong Knowledge of LIMS Labware Static Data Build.
  • Strong Knowledge of Empower Methods and Custom Field Build.
  • Knowledge of Perkin Elmer ELN preferred.
  • Project management skills.
  • Time Management.
  • Meetings Management.

 

 

11688 – Project Manager Non-IT - Cork

Purpose:

Project Manager will provide project execution support and expertise to the Technical Operations and Product Deletions teams on site to support the decommissioning of legacy product equipment, facilities and utilities and deletion of all associated processes and records and to provide Technical Project management support to Technical projects within the department. The team working style is one of collaboration, coaching and facilitating to provide solutions to the team to support a High-Performance Organization. The leadership style is one of collaboration, coaching and facilitating the Deletions team in a high performance organisation. This will require a substantial amount of time within the project process, engaging and communicating with stakeholders across the site and the Network.

Responsibilities:

  • This individual will be a part of a newly formed Product Deletion Program Team to ensure that the site delivers on key strategic projects and initiatives associated with legacy product deletions on site. These activities fall into but are not limited to the following categories:
  • Deletions Team:
    • Decommissioning of equipment, facilities and utilities.
    • Decontamination of equipment, facilities and utilities.
    • Deletion of documentation, processes and licenses associated with legacy products.
    • Decommissioning of analytical equipment, materials and documentation post stability period expiry.
  • Technical Operations Department:
    • Pharmaceutical product technical support.
    • Product technical transfers.
    • Process qualifications.
    • Ad Hoc projects within the Technical Operations Department.
  • Responsible for project oversight and control activities, including, definition of scope, business case development, business requirements definition, milestone identification, project governance, operational planning, risk identification & mitigation, implementation planning, project execution oversight and project closure.
  • Responsible for ensuring that projects are delivery on time, to agreed level of quality and within approved budget.
  • Oversite & control for project cost management through the project life cycles.
  • Delivery of effective & accurate project progress reports that can be analysed and understood at all levels within the organisation.
  • Responsible for project stakeholder management to ensure effective delivery of project objectives – including escalation management.
  • Creation and control of project plans for deletion of multiple products concurrently.
  • Responsible for project delivery risk and issue management, including the identification and implementation of risk and issue mitigating actions.
  • Motivate a multi-disciplinary team to achieve project objectives, through driving the team’s performance so that every individual understands their individual contribution and how it impacts the site.
  • Supporting and integrating with other site project managers/stakeholders to work in collaborative manner with other site projects.
  • Effectively communicating with and managing key stakeholders both internally and externally.
  • Proactively managing issues, proposing mitigation/response plans to resolve issues and effectively implementing the action plan.
  • Ensure there is a strong safety culture and performance in the execution of projects.
  • Lead teams providing on-going coaching and support to all team members, including the identification and development of key talent and skills within the Deletions program.
  • Sound financial stewardship, management and control.
  • Ensure highest Quality & Compliance standards. Participate and Comply with the company’s Quality Management System.

 

Minimum Qualifications and Experience:

  • Appropriate 3rd level or engineering trade qualification (Chemical Engineering, Science, Technical.)
  • A minimum of eight to ten years of relevant experience in project delivery of a broad spectrum of projects in the Pharma industry preferably including experience managing sterile or Biologics projects.
  • Strong Engineering and AIT background to project manage decommissioning activities for equipment, facilities and utilities.
  • Demonstrated experience of oversite & control for project cost management through the project life cycles in the range of €50mm project budgets.
  • Knowledge of and experience in applying Lean Six Sigma and Lean methodologies and Engineering excellence through OEE, predictive maintenance planning.
  • Demonstrated leadership skills with a continuous improvement focus.
  • Desirable: evidence of Continuous Professional Development.
  • Project management qualification such as Project Management Professional etc.
  • Lead six sigma experience is essential, minimum yellow belt, preferable green belt.
  • Demonstrated ability in holding project team members responsible for results and being decisive about non-performers.
  • Demonstrated successes in a team environment, such as project teams, Six Sigma team, PITs etc.
  • Demonstrated knowledge in pharmaceutical / biopharmaceutical technical / manufacturing operations.
  • Knowledge of Regulations and Change Control within the pharmaceutical industry.
  • Experience in FDA/HPRA regulated production environments.
  • Experience with Management Systems such as PM, EHS, Trackwise, SAP, PRINCE, Microsoft PM etc.
  • 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.

 

 

10472717 – QA Specialist - Athlone

Responsibilities:

  • Responsible, with management support, for providing oversight of quality activities associated with drug substance manufacturing processes.
  • Contributes and guides completion of milestones associated with specific projects and supports ongoing quality assurance responsibilities in support of: Manufacturing oversight and new product introduction including Change Control, Deviations, CAPAs and Supplier Management.
  • Performs all responsibilities in accordance with company policies, procedures, and federal regulations.
  • Responsible for supporting the company’s drug product manufacturing and assessing the compliance of this program against best industry practice and current regulatory expectations.

 

Minimum Qualifications and Experience:

  • Science qualification to BSc level is required.
  • Minimum 6 Month industry experience.
  • Good attention to detail.

 

 

10479819 – Manufacturing Engineer - Athlone

Purpose:

The Manufacturing Engineer is required to work with the Manufacturing Engineering Team on site in in the Biologics facility under the direction of the Manufacturing Engineer in the area. The chosen candidate will be working with and supporting other team members on the entire process to improve yield, productivity and ensure production targets are met. They will have assigned responsibilities for ensuring all manufacturing requirements are met from a process equipment perspective within the Biologics facility. In addition, they will be involved in ongoing and new projects and new product introduction activities. This is a technical role requiring problem solving through data analysis using scientific methods focusing on process capability. The role will require the candidate to work closely with other departments such as Manufacturing, Utilities and Quality Assurance. This role will report overall into the Manufacturing Engineering Lead and will offer scope for both personal and career development.

Responsibilities:

  • Involvement/leading process improvement projects as directed.
  • Practical problem solving and root case analysis.
  • Process parameter monitoring and control, yield analysis.
  • Follow through on actions logs, project milestones and presentations.
  • Look for new innovative technologies Build a deep understanding of process variables.
  • Daily, weekly & monthly reporting of product and process metrics.
  • Work with quality management systems, process change management, ISO, FMEA, risk assessment, standard work documents.

 

Minimum Qualifications and Experience:

  • Appropriate Engineering qualification. Ideally Chemical, Mechanical, Manufacturing or Material Engineering degree, NFQ Level 8 or higher.
  • Knowledge of Six Sigma and lean systems is an advantage.
  • IT literacy will ideally include SQL databases and Minitab.
  • Some experience in pharmaceutical processes is an advantage, particularly in a Biologics facility.
  • The candidate should be able to examine data to grasp issues, draw conclusions, and solve problems.
  • Ability to make informed and timely decisions that take into account the facts, goals, constraints, and risks associated.
  • A team player with a can do, pro-active attitude and a passion for improvement.

 

 

11638 - Data Integrity Support Specialist – Dublin

Responsibilities:

  • 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.
  • Responsible for all aspects of method and equipment validation, assisting in the effective and efficient running of the method and equipment validation programs.
  • Providing on-going technical support to the site in the area of contamination control.

 

Minimum Qualifications and Experience:

  • 4+ years’ experience
  • Works with moderate work direction and is skilled and knowledgeable to the position.
  • Knowledge and experience in interpreting current applicable regulatory requirements and providing independent support to the site.

 

 

11626 – Process Safety / EHS - Tipperary

Purpose:

An exceptional opportunity for an experienced S&E Specialist with specialisation in Process Safety to join the Environmental Health & Safety team and play an integral role in developing, maintaining and continually improving the EHS systems at our company’s API / Pharma facility to achieve its goals of Zero Harm, Sustainability and EHS Compliance. In this position you will be primarily responsible for the development, co-ordination and continual improvement and management of all aspects of the Process Safety Management program working with other S&E Specialists and stakeholders. You will provide technical guidance to the organisation to ensure compliance with all relevant legal requirements related to Process Safety as well as our company’s corporate standards, policies, procedures and guidelines and industry best practices. In addition, you will work with management to support the overall EHS Management System.

Responsibilities:

  • Developing and implementing the EHS programmes/policy required to ensure compliance with local legislation, our company’s standards and industry best practices.
  • Preparing Process Safety Procedures and other related documents.
  • Providing guidance and support to relevant stakeholders on all aspects of Process Safety Management.
  • Completing EHS Audits and Inspections and supporting external audits undertaken by Regulatory agencies, Insurance providers or corporate.
  • Liaising with regulatory authorities and corporate stakeholders as required.
  • Preparing / maintaining reports for site, corporate or regulatory agencies as required including the site Safety Report, MAPP and EPD documents.
  • Preparing Process Safety and Emergency Management training materials and delivery of training.
  • Providing Process Safety technical support to stakeholders during the introduction or modification of exiting processes and infrastructure.
  • Evaluating the Process Safety impacts associated with change relating to new projects, processes and infrastructure and changes to existing processes and infrastructure in accordance with site Change Management Procedures.
  • Completing/Chairing PHA studies (HAZOP/LOPA.)
  • Providing safety support for trouble shooting activities; participating in safety compliance reviews and providing technical support as necessary to resolve safety issues.
  • Completing investigations into process safety and general safety incidents and the development of corrective and preventative actions as required.
  • Supporting Installation Qualification and Operational Qualifications.
  • Participating in and approving pre-start up safety reviews and equipment walk-downs.
  • Maintaining compliance with the requirements of the Major Accident Prevention Policy (MAPP) and the COMAH Safety Management System (SMS.)
  • Providing technical guidance, review and approve changes to the Site Explosion Protection Document (EPD) under ATEX Regulations.
  • Supporting the Loss Prevention Program on site.
  • Participation in the site Process Safety Relief Device sizing program as required. Supporting the Fire System Coordinator in ensuring that effective processes are in place to ensure the prevention, mitigation and response to major accidents should they arise.
  • Participation in the site Process Safety Relief Device sizing program as required.
  • Monitor developments and advice Management on changes in Process Safety/COMAH related Standards and Legislation.

 

 

Minimum Qualifications and Experience:

  • Degree in Chemical Engineering or an Engineering / Science Degree with Higher Diploma in Chemical Engineering.
  • 3+ years’ EHS experience in Pharmaceutical or other industry which is regulated under the requirements of the SEVESO and Industrial Emission Directives.
  • Knowledge of HAZOP, LOPA and SIL.
  • Knowledge of ATEX/EPD.
  • Proven track record of success.
  • Experience on supporting multiple activities/projects.
  • Enthusiastic with a strong drive for to deliver results as per agreed commitments.

 

 

11623 – IT Project Engineer - Cork

Responsibilities:

  • Reporting to IT Lead, specifically responsible for delivery of local and globally initiated project(s.)
  • The IT engineer will lead the IT elements in project delivery – including deployment of new applications to site, and retirement of legacy systems.
  • Lead the IT deployment, configuration and installation of lab systems\business applications, and associated infrastructure, and liaise with the relevant stakeholders.
  • Ensure the appropriate quality documents, such as Quality Assurance (QAPs) test plans, Quality assurance summary reports (QASR) are in place, aligned with the qualification strategy of the project.
  • The candidate will be required to work closely with team members, both global and local, responsible for the full Automation and IT scope, and with vendors / partners with responsibility for delivery of systems, on which the hardware and AV components will rely.
  • The candidate will review and ensure vendors compliance with company quality and various “playbook” standards.
  • Assess the needs of the process, applications, environment, and users, to develop a shop floor hardware infrastructure for use in a manufacturing or lab facility and supporting areas.
  • Develop SDLC deliverables, compliant with company standards, to ensure consistent implementation of hardware devices and AV components.
  • Provide guidance and support to AIT team members tasked with delivery of key systems.
  • Provide input to the development of realistic project schedules and document trackers.
  • Work closely with suppliers / integrators to ensure compliance with company standards.
  • Participate in, and support, relevant project meetings.
  • Liaise with the various stakeholders on the overall project to ensure clear communication between all parties in relation to AIT validation requirements.

 

Minimum Qualifications and Experience:

  • Relevant Computer Science or Engineering degree or equivalent.
  • Minimum of 5 years’ experience in a similar role, ideally in the Pharmaceutical industry.
  • Practical awareness of GAMP5.
  • Strong experience in one or more of the following systems: VMWare, Acronis, Ghost, Windows OS.
  • Usual place of work will be in Cork Ireland. The successful candidate may sometimes be required to attend meetings at other company sites, off-site.
  • Excellent computer skills, proficient in the use of the following Microsoft tools: Excel, SharePoint, Word and PowerPoint.
  • Fluent in English, written and verbal.
  • Strong interpersonal and communication skills (verbal and written.)

 

 

10579312 – Quality Assurance Documentation - Dublin

Responsibilities:

  • Assessment, coordination and withdrawal of documents within the Electronic Document Management System (eDMS.)
  • Collaboration with document owners to facilitate efficient processing of impacted documentation.
  • Generation of queries and reports from eDMS.
  • Interface between Document Control and Training Operations to ensure updated documents are transitioned into the Learning Management System (LMS.)
  • Generation, development and communication of project metrics and status updates.

 

Minimum Qualifications and Experience:

  • BSc. in science/engineering with a minimum of 3-5 years’ experience in cGMP Quality environment; or equivalent combination of education and experience.
  • Knowledge of cGMP requirements for documentation control.
  • Direct experience with firstDoc eDMS or similar Documentum-based platform.
  • High level of organization required to plan, execute and track completion of project deliverables.
  • Excellent accuracy and attention to detail.
  • Excellent communication and interpersonal skills.

 

 

10475452 – Engineering Document Coordinator - Dublin

Responsibilities:

  • FirstDoc Coordinator via EDMS System.
  • Copy, scan and store documents via Sharepoint.
  • Receipt of Vendor and Contractor Turnover Packages.
  • Check for accuracy and edit project files.
  • File documents in physical and electronic copies.
  • Create templates for future use.
  • Retrieve files as requested by employees and contractors.
  • Manage the flow of documentation within the BDS Project.
  • Issue Documentation numbers.
  • Updating project procedures and fillable forms.
  • Documentation turnover transfer care, custody and control.
  • Prepare ad-hoc project reports as required.
  • Audit preparation.

 

Minimum Qualifications and Experience:

  • 3+ Years’ experience in a similar role is essential for this position.
  • Educated to Leaving Certificate standard (or equivalent.)
  • Proven work experience as a Document Controller or similar role.
  • Familiarity with project management.
  • Hands-on experience with MS Office and MS Excel.
  • Knowledge of Electronic Document Management Systems (EDMS.)
  • Proficient typing and editing skills.
  • Data organization skills.
  • Attention to detail.

 

9962016 – QA Specialist – Dublin

Purpose:

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

Responsibilities:

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

 

Minimum Qualifications and Experience:

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

 

 

11016 – Quality Specialist – Tipperary

Purpose:

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

Responsibilities:

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

 

Minimum Qualifications and Experience:

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

 

11557 – Process Engineer – Dublin

Responsibilities:

  • Development, review and approval of technical information including Safety Risk Assessments, Work Plans, Commissioning documents and CMMS data.
  • Establish Equipment Criticality and apply appropriate reliability and asset management strategy based on criticality
  • Ensure compliance to all Safety, regulatory GMP and Environmental requirements.
  • Working with technicians and other functions to develop Prescriptive, Predictive and Preventative maintenance program to ensure designated site equipment operate safe and reliable. Optimise work tasks, ensure spare parts, tools or other services are available when required.
  • Investigate equipment failures or deviations to find root cause and implement effective Corrective and Preventative Actions.
  • Provide technical training to colleagues.
  • Develop and manage KPI’s – ie People, Safety, Quality, Delivery and Cost performance.
  • Support Engineering Excellence Initiatives – participate in local and corporate programs.
  • Pursues and use new technologies and methodologies.
  • Own the initiation, management and closure of change initiatives.

 

Minimum Qualifications and Experience:

  • An engineering qualification with evidence of continuous professional development.
  • Having a minimum of 5 years in an Engineering role with extensive cGMP experience, ideally covering GMP Critical Utilities Equipment Engineering.
  • Experience of operations and maintenance of utilities in a biologics facility which should include Water, HVAC and Electrical Systems
  • Knowledgeable of mechanical, electrical, control and automation systems maintenance requirements.
  • Experience of writing Operating Procedures.
  • Experience in root cause analysis and writing GMP deviation investigations.
  • Experience of continuous improvement and maintenance optimisation techniques.
  • Some experience of data analytics, reviewing of trends and development and management of alerts.
  • Working knowledge of SAP or another Maintenance Management System.
  • Knowledge and Experience of Utilities Safety requirements, Statutory Inspections and Contractor Management
  • Excellent organising and planning skills
  • Excellent verbal and written communication skills
  • Ability to work independently and as part of a team in a cross functional collaborative environment
  • High level of attention to detail and strong problem-solving abilities

 

11571 – Technical Specialist – Materials Review – Cork

Purpose:

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

Responsibilities:

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

 

Minimum Qualifications and Experience:

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

 

11556 – Process Equipment Engineer – Dublin

Responsibilities:

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

 

Minimum Qualifications and Experience:

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

 

 

11559 – Quality Technician (QC Analyst) - Dublin

Responsibilities:

  • The motivation to be an inspiring member of a high performing team.
  • The desire to continuously learn, improve and develop.
  • Perform supporting activities for general lab readiness, laboratory equipment qualification and method transfers.
  • Perform and carry out a variety of routine microbiological analytical techniques including but not limited to environmental monitoring, WFI testing, growth promotion testing, In-process product testing, Final product testing such as bioburden and both Kinetic turbidimetric and MCS rapid endotoxin testing in compliance with GMP requirements.
  • To integrate and complete all documentation on time and be familiar with LIMS.
  • To train and be trained in the use of Rapid microbiology techniques including but not limited to endotoxin testing, water bioburden testing, E.M testing, absence of bioburden testing and identification testing.
  • Follow up-to-date analytical practices with reference to pharmacopoeias, specifications, regulations and industry standards.
  • To update SOP’s and write protocols as required.
  • 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.
  • Reagent preparation, cleaning, and routine equipment maintenance.
  • Maintain good housekeeping and GLP 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 in the implementation and maintenance of the relevant safety programmes.
  • Participate and Comply with the company’s Quality Management System requirements.
  • Responsible for driving a culture of Continuous Improvement by deploying company Six Sigma tools.

 

Minimum Qualifications and Experience:

  • 1-3 years industry experience with significant knowledge and experience in working in a microbiology lab unit and working with contract labs.
  • Experience in compendial testing for water and environmental monitoring in clean room environments.
  • Working knowledge of QC Systems (Empower, LIMS, Trending systems.)
  • Degree qualification (Science/Quality/Technical).
  • Preference Lean Six Sigma
  • Ability to respond to changing priorities.
  • Strong organisational skills.
  • Good aseptic technique and awareness of contamination control.
  • Good verbal and written communication skills.
  • Troubleshooting and problem-solving skills.
  • Good attention to detail.
  • Ability to think logically and be proactive.
  • Ability to work as part of a team and on own initiative in a constructive manner.
  • Flexible and self-motivated.

 

 

11496 – QA IT Specialist - Cork

Purpose:

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

Responsibilities:

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

 

Minimum Qualifications and Experience:

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

 

 

9917361 – QA Specialist III - Dublin

Purpose:

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

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

Responsibilities:

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

 

Minimum Qualifications and Experience:

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

 

 

9060112 – Lab Investigation Specialist - Dublin

Purpose:

This position is responsible for conducting and documenting investigations associated with the company 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

 

 

10465099 – Technical Services Scientist - Dublin

Purpose:

Working as part of the External Technical Services, the manager will be responsible for the technical aspects of Drug Product (Fill Finish) manufacturing at Contract Manufacturing Organisation (CMO) sites. Key deliverables will drive problem solving, shareholder management, process optimization and improvement become the SME.

Responsibilities:

  • Act as subject matter expert in for Drug product processes, including technology transfer, process evaluation, problem solving and investigation.
  • Work through collaborate within the organization to drive for results
  • Provide SME input for IND, BLA and other technical documents for regulatory agency submission in support of manufacturing process operated at CMOs.
  • Provide expertise in trouble shooting activities to support manufacturing either on site or virtually.
  • Identify and lead process optimization initiatives and address opportunities for efficiency and capacity improvements in all areas of manufacturing.
  • International travel may be required.

 

Minimum Qualifications and Experience:

  • Minimum Bachelors’ degree in Engineering (Chemical, Biochemical) or related field. Advanced degree would be an advantage.
  • Minimum of five years’ experience in providing technical support to Drug Product manufacturing (facility design, technology transfer or routine cGMP manufacturing)
  • Comprehensive knowledge of formulation and aseptic fill finish unit operations and freezing drying
  • Good understanding of cGMP requirements for commercial Drug Product manufacturing
  • Experience of technology transfers and scale-up
  • Proven ability to work independently and to build highly effective relationships both within and external to the company
  • Organised analytical thinker with strong attention to detail
  • Excellent oral and written communication skills, including technical writing
  • Experience of working with CMOs would be a distinct advantage

 

 

10570312 – QA Specialist III – Dublin

Purpose:

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

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

Responsibilities:

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

 

Minimum Qualifications and Experience:

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

 

 

2020-330 – Quality Assurance Manager – Fill Finish – Waterford City

Purpose:

The QA Manager Sterile Fill Finish is responsible for all aspects of assigned QA Team; provides leadership and support to direct reports. Provides QA oversight to ensure that all drug product manufacturing activities are compliant with company policies, procedures and in accordance with cGMPs.

Responsibilities:

  • Support the Head of Quality with the quality function oversight
  • Maintain the company Pharmaceutical Quality System to include: Personnel, Premises & Equipment, Production, QC, Outsourced activities, Complaints, Investigations, Self-Inspections
  • Ensure all work carried out is compliant with company standards, cGxP, SOPs, regulations and guidelines, safety and environmental guidelines
  • Continuously promote a positive safety culture. Implement Safety requirements as per site documentation including SOPs, Safety Statement
  • Collaborate cross functionally with all departments and represent Quality on the Sterile Supply Value Stream
  • Investigations management and approval
  • Deviations & Complaints
  • Out-of-Specifications, Out-of-Calibrations, Out-of-Trends
  • Elevate Quality issues to the Head of Quality and Senior Management where required, working collaboratively with the Sterile Fill Finish Manager to provide direction and support in critical interventions
  • Manage Self Inspection Program
  • Manage and host site Inspections (Customer audits / Regulatory inspections etc.)
  • Batch documentation review ensuring compliance to standards and SOP’s
  • Batch package preparation for QP release
  • Manage Vendor Qualification
  • API and excipient disposition
  • Primary & Secondary component disposition
  • Provide oversight of any Contract Manufacturing activities related to Sterile Fill Finish
  • Manage metrics, performance, and review with the Site Leadership Team
  • Quality management representative on the company’s Area Management Team, ensuring effective running of the business
  • Involved in the recruitment, leadership, and career development of Quality Assurance members
  • Creation of Quality department goals aligned with site strategy and objectives
  • Performance evaluations for direct reports
  • Quality department budgeting
  • To perform additional tasks as agreed to support effective running of the business.

 

Minimum Qualifications and Experience:

  • Primary degree in a scientific discipline
  • Minimum 8 years’ experience in the biopharmaceutical industry, 5 of which should be within a Quality function
  • Minimum 4 years leadership experience, including team coaching and development
  • Experience of Quality Assurance of aseptic medicinal products and in particular biopharmaceuticals.
  • Experience in using lean methodologies and / or operating within Value Streams
  • Candidate is eligible to act as a Qualified Person as described in EU Directives, would be an advantage
  • Extensive knowledge of electronic QMS systems – EDMS, ERP, TrackWise etc.
  • Experience preparing and hosting Customer & Regulatory Inspections
  • Lead auditor experience

 

 

11545 – QA Document Control - Cork

Purpose:

This fixed term contract position within the QC Labs will provide an effective document control system by performing issuance and reconciliation cGMP documentation to support testing of our products. You will be responsible for the control, distribution and archiving of cGMP documentation throughout its lifecycle so that we are providing a robust quality focused system.

Quality oversight, support and knowledge to activities relating to Quality Documentation System across QC Labs and in meeting the company priorities of: Compliance, Supply, Strategy and Profit Plan. The team working style is one of collaboration, coaching and facilitation to ensure the success of the site. This role requires the delivery of a robust Quality Documentation System to support a flexible, collaborative, multi-skilled teamwork environment. The Quality Specialist will have proven capability in the development and maintenance of Quality Documentation Systems. The successful candidate will be an active member of cross functional teams and be focused on delivering and championing process improvement. The Quality Specialist will participate and comply with the company Quality Management System (QMS) requirements, including ownership.

Responsibilities:

  • Provides to the site knowledge and experience in Quality Documentation Systems.
  • Responsible for the QC Labs Documentation System including Issuance, reconciliation, storage, archiving and retrieval of cGMP documentation to support the testing of our products.
  • Uses knowledge to improve Quality Documentation Systems, solve problems, provide continuous improvement and execute tasks.
  • Provides compliance contribution to project teams.
  • Complete documentation audits.
  • Understands and applies regulatory / compliance requirements to their role together with remaining current on upcoming regulatory and compliance changes.
  • Responds to non-standard requests from customer needs.
  • Makes decisions within guidelines and policies which impact own priorities and allocation of time to meet deadlines.
  • Ensures supply of high-quality product through the implementation and oversight of the Quality Documentation System for the QC Labs.
  • Champion the highest Quality and Compliance standards for QC Labs.
  • Ensure highest safety standards.

 

 

Minimum Qualifications and Experience:

  • A qualification in a quality discipline is desired with 1-2 years pharmaceutical / documentation experience. However, a combination of experience and/or education will be taken into consideration.
  • Experience in a similar regulated documentation role is strongly preferred.
  • cGMP documentation control SME knowledge, from both operational and educational experience, is required.
  • Must possess excellent communication skills (verbal & written). Must have excellent organizational (Time Management) skills, attention to detail and computer skills including Excel, Word and Sharepoint. Be able to work as a flexible member of a Quality team.
  • Ability to collate and control GMP documentation.
  • Strong proven attention to detail is necessary to be successful in this team.
  • Good organisational skills are required with an ability to manage multiple priorities.
  • Demonstrated ability to work independently and fully realize improvement initiatives with a moderate level of guidance.
  • Understand the business needs and customer asks. Know how to prioritise requests.
  • Demonstrated ability to drive the completion of tasks.
  • Advanced PC skills such as Excel, Word, PowerPoint.
  • Energetic with proactive & positive attitude.
  • Evidence of Continuous Professional Development desirable.

 

 

11534 – Process Project Engineer - Carlow

Purpose:

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

Responsibilities:

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

 

Minimum Qualifications and Experience:

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

 

 

11530 – Quality Technical Specialist - Cork

Purpose:

Our client in Cork is hiring a Technical Specialist within the Lab Operations Technical IPT. This position requires someone with strong technical knowledge and experience in Chemistry/Raw Material analytical methods with multidisciplinary expertise to provide technical support to the commercial testing laboratories. The Technical Specialist will provide technical expertise and coaching to the Quality Laboratories for routine technical support and investigations. The Technical Specialist is accountable for the effective and efficient running of projects within cross-functional multi-skilled teamwork environment, collaborating effectively with stakeholders.

Responsibilities:

  • Good knowledge of protein chemistry analytical and compendial methods.
  • Abreast with EU/US regulations for analytical and compendia methods within in GMP environment.
  • Provide technical expertise and coaching to support lab operations.
  • Lead the delivery and of projects whilst adhering to project timelines through the use of project management tools.
  • Prepare, review and approval of technical documents, procedures, CAPAs, change control, deviations, in accordance with GDP (good documentation practice) and site procedures.
  • Lead cross-functional problem-solving teams for troubleshooting, and investigations within local Quality, other company Sites and contract laboratories as required.
  • Lead continuous improvement initiatives to drive efficiencies within the department.
  • Preparation of documentation associated with the projects in accordance with GDP (good documentation practice) and site procedures.

 

Minimum Qualifications and Experience:

  • Degree or 3rd level qualification (Science, Engineering, Quality). Masters preferred.
  • Knowledge of protein chemistry and analytical and compendial methods.
  • Desired;
    • D./M.Sc. qualification (Science)
    • Knowledge of and experience in applying Six Sigma and Lean methodologies.
    • Project management qualification such as Project Management Professional etc.

 

 

11529 – Validation Engineer - Cork

Purpose:

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

Responsibilities:

  • Ensure highest Quality, Compliance and Safety standards are adhered to.
  • Validation protocol/report authoring/execution/oversight/approval as appropriate.
  • Recommend and approve technical approaches in line with global and local standards.
  • Maximize team member performance through continuous process improvement initiatives, coaching, and providing guidance to team members.
  • Benchmark and remain current with development of new technologies in the vaccine and biopharmaceutical processing field of expertise and seek to deploy process improvements through innovation and utilization of these technological advances.
  • Participate in problem solving teams across all areas of the Vaccine IPT.
  • Lead process related deviations and reports.

 

Minimum Qualifications and Experience:

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

 

 

11528 – Validation Engineer - Cork

Purpose:

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

Responsibilities:

  • Ensure highest Quality, Compliance and Safety standards are adhered to.
  • Validation protocol/report authoring/execution/oversight/approval as appropriate.
  • Recommend technical approaches in line with global and local standards.
  • Conduct detailed technical assessments of materials and supplier changes and proactively manage the implementation of changes.
  • Maximize team member performance through continuous process improvement initiatives.
  • Benchmark and remain current with development of new technologies in the vaccine and biopharmaceutical processing field of expertise and seek to deploy process improvements through innovation and utilization of these technological advances.
  • Participate in problem solving teams across all areas of the Vaccine IPT.
  • Support process related deviations and reports.

 

Minimum Qualifications and Experience:

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

 

 

11527 – Health & Safety (COVID Site Coordinator) - Dublin

Purpose:

The COVID Site Co-ordinator will be responsible for the leading, implementation and monitoring of the site response measures to the pandemic. The role will involve engagement with both the company sustain team and the GES/JV project team and JV site representative.

Responsibilities:

  • Develop, implement and maintain the Site Response Plan based on HSE, Government, Corporate and other best practice requirements, guidance and advice.
  • Work with COVID Champions site representatives and People Managers to;
    • Review and Trend Safety Observations relating to COVID 19.
    • Develop Weekly Metrics report and share with Senior Leaders and COVID Champions.
    • Complete Site GEMBA’s and inspections.
    • Act on any deficiencies noted on GEMBA’s (COVID focus.)
    • Work with other company sites to share practices and develop common approaches to response measures where applicable.
    • Attending regulatory inspections, communication and co-action plans.
  • Provide Daily and Weekly updates to Site Teams and Leadership Group as required.

 

Minimum Qualifications and Experience:

  • 8-10 years’ experience.
  • Knowledge of Government Regulations and Recommendations, working of Agencies and regulatory bodies, legal requirements and controls.
  • Compliance auditing / Inspection experience with regulatory agency such as HAS.
  • Experience in risk management.
  • Experience in basic statistical analysis, trending and reporting.
  • Previous experience in a safety and/or compliance role.
  • Some knowledge of manufacturing operations and construction activities.
  • Strong leadership ability.
  • Integrity and professional ethics.
  • Ability to develop communications and roll out to site teams.
  • Trending of information and using data to drive decision.

 

 

11455 – Validation 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 site 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 the company Global Policies, Procedures and Guidelines, regulatory requirements and execute current Good manufacturing Practices (cGMP) in the performance of day to day activities and all applicable job functions, ensuring consideration of the impact on GMP and compliance and decisions made.
  • Accountable for compliance via documentation completion, risk assessments, closing out corrective action, participate in audits and inspections and proactively highlighting any issues around compliance.
  • Work collaboratively to drive a safe and compliant culture in Carlow.
  • May be required to perform other duties as assigned.

 

Minimum Qualifications and Experience:

  • Bachelor’s Degree or higher preferred; ideally in a Science, Engineering or other Technical discipline.
  • Knowledge of regulatory/code requirements to Irish, European and International Codes, Standards and Practices.
  • Report, standards, policy writing skills required.
  • Equipment and process validation.
  • Sterile filling processes and equipment.
  • Proficiency in Microsoft Office and job-related computer applications required.
  • Lean Six Sigma Methodology experience desired.

 

 

10456804 – QA Manager (QP) - Dublin

Purpose:

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

Responsibilities:

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

 

Minimum Qualifications and Experience:

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

 

 

11445 – QA Technical Specialist - Cork

Purpose:

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

Responsibilities:

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

 

Minimum Qualifications and Experience:

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

 

 

2020-323 – QC & Stability Chemist – Waterford City

Purpose:

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

Responsibilities:

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

 

Minimum Qualifications and Experience:

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

 

 

10203763 – QC Compliance Optimisation Specialist - Athlone

Purpose:

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

Responsibilities:

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

 

Minimum Qualifications and Experience:

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

 

 

11269 – C&Q Project Manager - Carlow

Responsibilities:

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

 

Minimum Qualifications and Experience:

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

 

 

10755 – Validation Engineer - Cork

Purpose:

The Validation Engineer/ Technical Specialist will be required to collaborate and facilitate running of activities (PPQ batch manufacture, validation activities, investigations, change control) in the Vaccine IPT to ensure the effective and efficient on-time delivery of these activities for the Vaccine IPT. This requires the delivery of technical excellence to deliver components of a stable process, supported by a flexible, collaborative, multi-skilled teamwork environment.

Responsibilities:

  • Ensure the highest Quality, Compliance and Safety standards primarily not only with Technical/Validation activities but relating to all activities to enable the team’s performance in the Vaccine Technical group within the Vaccine IPT.
  • Project validation support including conducting equipment performance qualifications (cleaning and sterilization validation periodic reviews, re-qualifications, temperature mapping.)
  • Authoring project validation master plans, SOP and documentation updates, authoring validation protocols and final reports, executing validation studies, analysis of validation data.
  • Resolving technical issues encountered during study execution. Lead and close process related deviations and reports and participate in problem solving teams across all areas of the Vaccine IPT (e.g. reliability, Safety, Quality (e.g. CAPA/DN/MDNs etc.)
  • This individual will be required to work in a cross-functional team and independently to accomplish validation project objectives.
  • Experience with audits and preparation for audits.
  • Works with moderate work direction and is skilled and knowledgeable to the position.
  • Responsible for the technical support of manufacture in the Vaccine IPT.
  • Technical review, ownership of and approval of Global Change Management records as required.
  • Recommend technical approaches in line with global and local standards.
  • Contribute for driving a culture of Continuous Improvement by deploying Our Company Six Sigma tools and MPS within the IPT on projects such as: problem solving, reducing cycle time, lean principles within the new processes.
  • Stakeholder management of multiple decision makers, corporate colleagues, cross-functional team by demonstrating the ability to maintain and strengthen trust relationships with people on all levels.
  • Participate and comply with the Manufacturing Division Quality Management System (QMS) requirements, including ownership, as relevant.

 

Minimum Qualifications and Experience:

  • Degree or Masters in a Science or Engineering discipline (preferably Biotechnology.)
  • 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.

 

 

10069 – 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 revalidation.
  • Design/Author/Review/Approve/Execute qualification/validation documentation and studies in line with the standard approval process.
  • Perform data analysis and make informed decisions/recommendations around conclusions reached from data analysis.
  • Support continuous improvement through Lean Six Sigma methodologies.
  • Leading and active participation in projects, system failure investigations and investigation reports.
  • Execution/development of change controls.
  • Contribution to Kaizen events as appropriate.
  • Perform root cause analysis of system failures, substandard performance, using standard tools and methods, to resolve machine and system issues e.g. FMEA, Fishbone diagrams, 5 why’s etc.
  • Implement subsequent corrective action through the change management system.
  • Serve as technical engineering representative for internal technical group discussions and represent the company at global technical forums.
  • Participate and/or lead cross functional or single function teams including liaising with vendors or above site groups.
  • Drive compliance of company Global Policies, Procedures and Guidelines, regulatory requirements and execute current Good manufacturing Practices (cGMP) in the performance of day to day activities and all applicable job functions, ensuring consideration of the impact on GMP and compliance and decisions made. Accountable for compliance via documentation completion, risk assessments, closing out corrective action, participate in audits and inspections and proactively highlighting any issues around compliance.
  • Work collaboratively to drive a safe and compliant culture in Carlow.
  • May be required to perform other duties as assigned.

 

Minimum Qualifications and Experience:

  • Bachelor’s Degree or higher preferred; ideally in a Science, Engineering or other Technical discipline.
  • Relevant experience and a particular skill set in their area of expertise that adds value to the business; ideally in a manufacturing, preferably in a GMP setting.
  • Knowledge of regulatory/code requirements to Irish, European and International Codes, Standards and Practices.
  • Report, standards, policy writing skills required.
  • Equipment and process validation.
  • Sterile filling processes and equipment.
  • Proficiency in Microsoft Office and job related computer applications required.
  • Lean Six Sigma Methodology experience desired.

 

 

10120867 – Planning Specialist - Dublin

Purpose:

Position drives the planning of Working Cell Bank, Drug Substance, Drug Product and Finished Product production schedules for the internal and external manufacturing sites to ensure product needs of Commercial and Clinical Operations are met for all Complement products. Provides both short and long term planning oversight and optimization of product inventories, manages data, and provides reports to internal and external leaderships teams. The successful applicant will have very strong leadership competencies and capabilities and therefore possess the capability to progress through the organization into roles of increasing responsibility in the future.

Responsibilities:

  • Provides short and long term planning oversight and optimization of inventories of working cell bank, drug substance, drug product and finished product in the relevant suppliers, countries and distribution centers, including New Product Introduction.
  • To perform key scenario planning analysis based on supply chain challenges for GSC Leadership team review.
  • Drives the commercial demand review process with relevant commercial stakeholders.
  • Supports reconciliations for all stock locations and provides end of month data/reporting to Corporate Finance and External Audit Partners.
  • Work closely with regional commercial partners to understand sales forecasts, both performance against plan and anticipated changes, insuring inventory levels and production schedules can support market requirements.
  • Monitors compliance to the plan across the entire supply network.
  • Ensures data accuracy in all aspects of planning, as well as in the global planning ERP system.
  • Support the design and implementation of Supply planning metrics.
  • Ensuring compliance to Standard Operating Procedures and Good Distribution Practices.

 

 

Minimum Qualifications and Experience:

  • Third Level Degree qualification in a relevant discipline is desired.
  • 6 years+ in Supply Planning or associated experience.
  • Advanced level in MS Excel and intermediate level in other MS applications essential.
  • OMP Plus Planning Software Experience essential.
  • Advanced analytical skills and high attention to detail essential.
  • Strong knowledge of Supply Chain Planning concepts and strategies.
  • Prior experience with Advanced Supply Chain Planning Systems essential.
  • Knowledge of planning processes and distribution planning principles.
  • Ability to cope with fast-paced and dynamic business environment.
  • Prior SAP functional skills are preferred but not essential.
  • Familiarity with concepts of cGMP.
  • Ability to communicate and lead cross functional projects.

 

9751 – Project Manager Non-IT - Tipperary

Purpose:

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

Responsibilities:

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

 

Minimum Qualifications and Experience:

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

 

 

11153 – QC Instrumentation Specialist - Dublin

Purpose:

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

Responsibilities:

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

 

 

Minimum Qualifications and Experience:

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

 

 

2020-328 – QA Specialist - Waterford

Purpose:

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

Responsibilities:

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

 

Minimum Qualifications and Experience:

  • Bachelor’s degree in a science related subject is essential.
  • 3 years’ experience in a Quality Assurance role is preferable.
  • Operational experience of quality systems in a dynamic manufacturing environment.
  • Knowledge of requirements for cGMP, US and EU regulatory requirements.
  • Full understanding of relevant quality and compliance regulations.
  • Able to manage projects to plan/budget.
  • Effective facilitator.
  • Good communication skills at organisation, team and individual levels.
  • Understands KPI’s for the team and site.
  • Must be able to respond quickly to unplanned events, technical issues and changing needs from development programs.
  • All applicants must be open to shift work.

 

 

2020-327 – Statistician – Waterford City

Purpose:

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

Responsibilities:

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

 

Minimum Qualifications and Experience:

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

 

 

10016773 - Supply Chain Distribution Specialist - Dublin

Purpose:

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

Responsibilities:

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

 

 

Minimum Qualifications and Experience:

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

 

 

11027 - Process Engineer - Cork

Purpose:

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

Responsibilities:

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

 

Minimum Qualifications and Experience:

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

 

 

10784 - Talent Acquisition Specialist – Carlow

Purpose:

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

Responsibilities:

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

 

Minimum Qualifications and Experience:

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

 

 

9966920 – LIMS Specialist - Dublin

Purpose:

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

Responsibilities:

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

 

Minimum Qualifications and Experience:

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

 

 

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

Purpose:

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

Responsibilities:

  • To review raw data from testing of components/raw materials/finished products and stability in a timely & efficient manner.
  • To manage and control all raw data presented for review and file once completed.
  • To complete required release documentation including commercial stability summary sheets.
  • Trending of finished product and API testing.
  • Complete investigations in a timely and efficient manner where applicable.
  • Identify and action recommendations for improvements.
  • Implement 5S and Lean lab initiatives.
  • To support all other on-going laboratory functions & requirements.
  • To ensure that all work carried out is in compliance with the required standards conforming to company, cGxP, SOPs, regulatory regulations and guidelines, safety and environmental guidelines.
  • To identify and make recommendations for improvements as part of a team within or outside the department in order to ensure continuous improvement.
  • To perform additional team tasks as agreed to support effective running of the Business.
  • To assist in the preparation for customer/ regulatory inspections.
  • Health & Safety;
    • Implement safety requirements as per site documentation including SOPs, Safety Statement and COPs.
    • Report any defects.
    • If unsure about safety requirements – ask.

 

Minimum Qualifications and Experience:

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

 

 

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

Purpose:

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

Responsibilities:

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

 

Minimum Qualifications and Experience:

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

 

 

2020-323 - QC & Stability Chemist - Waterford City

Purpose:

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

Responsibilities:

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

 

Minimum Qualifications and Experience:

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

 

 

2020-322 - QA Team Lead - Waterford City

Purpose:

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

Responsibilities:

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

 

 

Minimum Qualifications and Experience:

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

 

 

2020-321 - Maintenance Technician - Waterford City

Purpose:

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

Responsibilities:

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

 

 

Minimum Qualifications and Experience:

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

 

 

2020-320 - Junior Process Engineer - Clonmel

Purpose:

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

Responsibilities:

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

 

 

Minimum Qualifications and Experience:

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

 

 

2020-319 - Project Engineer - Clonmel

Purpose:

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

Responsibilities:

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

 

Minimum Qualifications and Experience:

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

 

 

2020-318 - Technical and Process Specialist - Clonmel

Purpose:

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

Responsibilities:

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

 

Minimum Qualifications and Experience:

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

 

 

9741959 – Senior QA Specialist – Dublin

Purpose:

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

Responsibilities:

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

 

 

Minimum Qualifications and Experience:

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

 

 

10573 - Process Engineer - Tipperary

Purpose:

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

Responsibilities:

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

 

Minimum Qualifications and Experience:

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

 

 

10555 - Automation Engineer - Tipperary

Responsibilities:

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

 

Minimum Qualifications and Experience:

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

 

 

2020-312 - QC Chemist - Waterford City

Purpose:

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

Responsibilities:

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

 

Minimum Qualifications and Experience:

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

 

 

9741959 - Senior QA Specialist - Dublin

Purpose:

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

Responsibilities:

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

 

 

Minimum Qualifications and Experience:

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

 

 

 

2020-306 - Engineering Project Manager - Waterford City

Purpose:

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

Responsibilities:

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

 

Minimum Qualifications and Experience:

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

 

10264 - Scientific Technical Specialist - Cork

Purpose:

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

Responsibilities:

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

 

 

Minimum Qualifications and Experience:

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

 

Associate Director (MPS) - Leinster

Purpose:

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

 

Responsibilities:

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

 

 

Minimum Qualifications and Experience:

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

 

 

Senior Microbiologist - Cork

Purpose:

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

 

Responsibilities:

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

 

 

Minimum Qualifications and Experience:

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

 

 

2019-298 - 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.

 

 

2019-297 - Senior Microbiologist - Waterford City

Purpose:

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

 

Responsibilities:

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

 

Minimum Qualifications and Experience:

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

 

Clinical Affairs Manager (Veterinary) - Waterford City

Purpose:

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

 

Responsibilities:

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

    Clinical Studies –

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

    Dossier preparation –

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

     Leadership

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

     Veterinary Business Strategy –

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

 

Minimum Qualifications and Experience:

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

 

QCQA Chemist - Waterford City

Responsibilities:

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

 

Minimum Qualifications and Experience:

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

 

9444 - Automation Engineer - Carlow

Purpose:

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

 

Responsibilities:

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

 

Minimum Qualifications and Experience:

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

 

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

Responsibilities:

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

 

Minimum Qualifications and Experience:

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

 

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

Purpose:

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

 

Responsibilities:

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

 

Minimum Qualifications and Experience:

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

 

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.

 

2019-236 - Senior Regulatory Affairs Specialist - Waterford City

Responsibilities:

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

 

Minimum Qualifications and Experience:

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

 

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

Description:

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

Responsibilities:

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

Minimum Qualifications and Experience:

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

 

2019-232 - Engineering Project Manager - Waterford City

Description:

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

Responsibilities:

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

Minimum Qualifications and Experience:

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

 

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

Responsibilities:

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

Minimum Qualifications and Experience:

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

 

2019-225 - Senior Molding Engineer - Clonmel

Description:

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

Responsibilities:

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

Minimum Qualifications and Experience:

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

Senior Quality Engineer (R&D) – Waterford City

Description:

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

Responsibilities:

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

Scope of Position:

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

Minimum Qualifications and Experience:

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