CQV Engineer

CQV Engineer

Posted 3 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 commissioning readiness, leading CQV deliverables, and managing project lifecycle systems. This role offers a significant opportunity to contribute to the biopharmaceutical industry through process development and cGMP production. The ideal candidate will have extensive experience with process equipment and expansion projects.

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!