CQV Engineer

CQV Engineer

Posted 2 days ago by QCS Staffing

Negotiable
Undetermined
Undetermined
York, England, United Kingdom

Summary: The CQV Engineer role involves supporting a large-scale CAPEX investment program within a global pharmaceutical manufacturing company. The position focuses on ensuring the commissioning readiness of systems, leading CQV deliverables, and managing project lifecycle activities. This role offers an opportunity to contribute significantly to the biopharmaceutical industry through process development and cGMP production.

Key Responsibilities:

  • Liaise with CQV PM and Lead Scheduler.
  • Ensure Commissioning readiness of all Systems to support Equipment Start-up and IOQ Testing.
  • Lead CQV interface with EIDA / or Master Project Database equivalent system, ensuring full traceability at all times for all systems within the fill finish building.
  • Liaise with all Project Groups to ensure all Systems are managed appropriately for the Project Lifecycle.
  • Lead execution of all CQV deliverables; IOQ, field execution.
  • Responsible for the generation of Test Protocols for the verification of process equipment.
  • Execution of the protocols utilizing data generated by equipment vendors.
  • Execution of any remaining testing requirements.
  • Oversight of vendor testing.
  • Generation of reports.

Key Skills:

  • Extensive experience including experience with expansion projects.
  • Experience working with process equipment including filtration systems, chromatography equipment and consumables, bioreactors, cell culture systems, mixing systems, bioprocessing.

Salary (Rate): undetermined

City: York

Country: United Kingdom

Working Arrangements: undetermined

IR35 Status: undetermined

Seniority Level: undetermined

Industry: Other

Detailed Description From Employer:

CQV Engineer- UK, Yorkshire - 9 Month Contract

Our client, a global CDMO in pharmaceutical manufacturing, is recruiting for a CQV Engineer to join their new and exciting large-scale CAPEX investment programme. With a mission to provide process development and cGMP production in cell culture, microbial fermentation, and gene therapies, this is an outstanding opportunity make a genuine contribution to the biopharmaceutical industry.

Responsibilities Include

  • Liaise with CQV PM and Lead Scheduler.
  • Ensure Commissioning readiness of all Systems to support Equipment Start-up and IOQ Testing.
  • Lead CQV interface with EIDA / or Master Project Database equivalent system, ensure full traceability at all times for all systems within the fill finish building
  • Liaise with all Project Groups to ensure all Systems are managed appropriately for the Project Lifecycle.
  • Lead execution of all CQV deliverables; IOQ, field execution
  • Responsible for the generation of Test Protocols for the verification of process equipment.
  • Execution of the protocols utilising data generated by equipment vendors.
  • Execution of any remaining testing requirements.
  • Oversight of vendor testing.
  • Generation of reports.

Key requirements include:

  • Extensive experience including experience with expansion projects.
  • Experience working with process equipment including; filtration systems, chromatography equipment and consumables, bioreactors, cell culture systems, mixing systems, bioprocessing

If this role is of interest, please apply now!