Be part of a multi-discipline team (in a seconded client role) responsible for Commissioning & Qualification (C&Q) activities on a large Drug Product facility, directing the activities of the C&Q partner on site. The successful candidate will take systems from the Design Phase through Construction Handover stage and carry them through the Commissioning and Validation cycle to allow handover to Manufacturing. The candidate will be required to have an understanding of digital execution methods (KNEAT) for digital execution of C&Q lifecycle deliverables.
- Lead and coordinate a commissioning and qualification program for Drug Product formulation and filling, clean and black utilities, support services, and laboratory equipment.
- Lead the planning and tracking of activities, working with the assigned C&Q partner.
- Liase 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, CLIA etc), as required.
- Review and Input into deliverables such as technical requirement specifications and vendor turnover documentation.
- Owner of pre-requisite C&Q Strategy and deliverables (System Level Impact Assessment, Component Level Impact Assessments, System Boundary Drawings, Requirement Traceability Matrix).
- Oversees the generation, execution and approval of C&Q documentation in electronic format in KNEAT (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.
- Generate C&Q change controls (FPIDCNs 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 C&Q partner / suite team resources.
- Managing vendor engineers and contractors during C&Q activities.
- Managing the site attendance for the vendors, contractors and specialist contractors.
- Confirming all vendor documentation executions are compliant with GxP practices & the executed documentation is acceptable to support C&Q.
- Performing system P&ID walkdown with construction prior to handover.
- Categorisation of punchlist items & tracking to completion.
- Supporting review on all Isometrics, Weld logs, Weld Qualifications, 3rd Party Inspections, Material of Construction and Redlining exercise.
- Confirming the site installation is as per approved design specification and meeting system IQ requirements.
- Facilitating/expediting Mechanical Completion in conjunction with the Construction team. (Liaise with construction contractors towards successful completion of Construction Turn Over Documentation).
- Generating method statements, risk assessments & permit preparation for responsible areas from M/C to handover to site operations.
- Performing pre-start up safety checks, LOTO & ensuring timely loop checking and calibrations.
- Coordinating and supervising third party vendors during SAT execution.
- Reviewing and approving SAT protocols.
- Attending daily communication meetings with suite team lead and reporting progress.
- Assisting in investigations of process equipment, utility systems, and control system anomalies, as well as safety incidents.
- Maintaining a clean and safe working environment by enforcing procedures, policies, and regulations.
- Implement GES C&Q strategies as aligned with the Global C&Q Lead.
- Ensure that system delivery progresses in accordance with the approved project schedule.
- Notify project management, 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.
Qualifications & Experience:
- Bachelor of Engineering or Science Degree in Engineering or Technology related discipline.
- Minimum of 8 years’ experience in commissioning and/or validation of Drug Product/Facilities/Utilities systems within Pharmaceutical industry.
- Technical knowledge of utilities, filling and formulation equipment, biotechnology processes and a working knowledge of FDA and EU regulations is preferred.
- Minimum 5 years of experience with supervisory, project management and budget management are required.
- Working knowledge of process control systems and automation. DeltaV experience beneficial.
- Advanced knowledge of C&Q documentation required for cGMP process equipment and utilities.
- Experience using digital execution methods (i.e. KNEAT) for digital execution of C&Q deliverables.
- 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.
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