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Our client, aglobal CDMO in pharmaceutical manufacturing, is recruiting for aCQV 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.
- 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
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