Commission & Qualification Senior Specialist- Drug Product Facility
An expanding pharmaceutical plant based in Cork is looking a Commission & Qualification Senior Specialist for their Drug Product Facility.
Ideal candidate will be working closely with a cross-functional team and coordinate activities between Construction, Process, Technical Operations, IPT and QA
Commission & Qualification Senior Specialist will report to C&Q Technical Lead on the project.
- 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
- Manage the site attendance for the vendors, contractors and specialist contractors.
- 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.
- Bachelor of Engineering or Science Degree in Engineering or Technology related discipline.
- 3 years + experience in commissioning and/or validation of Drug Product Facilities/Utilities systems within Pharmaceutical industry.
- Technical knowledge of black utilities and clean utilities systems and equipment, biotechnology processes and a working knowledge of FDA and EU regulations is preferred.
- Experience in C&Q of Drug Product Facility
- Working knowledge of process control systems and automation. DeltaV, syringe & vial line experience beneficial.
- Fluent in English, written and verbal.
- Knowledgeable with latest industry standards and guidelines on C&Q, including ISPE/ASTM
For a confidential discussion on this or any other current job opportunity please contact Marcel Skolimowski on 021 4847 138 / email@example.com
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