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Commission & Qualification Senior Specialist

Job description

Commission & Qualification Senior Specialist- Drug Product Facility

Cork

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.

Job Responsibilities

  • 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.

Job Requirements

  • 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 / marcel@sigmar.ie

 

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