- Deliver end-to-end CQV lifecycle documentation: URS, DQs, FAT/SAT, IQ, OQ, and support for PQ where applicable.
- Perform equipment and system commissioning, including verification of installation, utilities integration, control functionality, and safety systems.
- Lead CQV efforts on systems including (but not limited to): - Bioreactors and single-use technologies - Chromatography Columns - Clean-in-place (CIP) and steam-in-place (SIP) systems - WFI, clean steam, and process gases - Process tanks, skids, and associated piping
- Conduct impact assessments, risk assessments (e.g. ASTM E2500), and define appropriate qualification strategies.
- Bachelor's degree in Engineering, Life Sciences, or related technical field.
- Minimum 5 years' CQV experience in a GMP-regulated drug substance or biologics manufacturing environment.
- Demonstrated hands-on experience with commissioning and qualification of: - Large-scale bioprocess equipment - Utility systems (WFI, HVAC, compressed gases, clean steam) - Automation-integrated equipment (DeltaV)
