What are the responsibilities and job description for the Commissioning & Qualification Lead - Bioprocessing Equipment position at Warman O’Brien?
C&Q Lead – Bioprocessing Equipment
Warman O’Brien is delighted to partner with a Leading Pharmaceutical Company seeking an experienced C&Q Lead to oversee commissioning, qualification, and validation (CQV) activities for upstream and downstream bioprocessing equipment. This is a long-term, 12-month extendable project.
Responsibilities:
- Develop and execute risk-based C&Q plans for upstream/downstream equipment following ASTM E2500, ISPE C&Q Guide, and GAMP 5.
- Lead DQ/IQ/OQ/PQ for buffer preparation skids, UF/DF filtration, homogenizers, and biotinylation skids.
- Qualify Single-Use Technologies (SUT), including leak detection, extractable/leachable (E/L) studies, and material compatibility assessments.
- Author and approve C&Q protocols, risk assessments (FMEA), and validation reports ensuring FDA/EMA compliance.
- Conduct System Impact Assessments (SIA) to prioritize validation activities based on patient risk and regulatory requirements.
Experience & Skills:
- 10 years of CQV leadership experience in biologics or vaccine manufacturing.
- Hands-on expertise with upstream (media/buffer systems, perfusion bioreactors) and downstream (chromatography, viral filtration, TFF skids) equipment.
- Proficiency in DeltaV, Kneat, or ValGenesis for electronic validation workflows.
1099 Contract
Competitive Hourly Rate
Full time onsite - 40 hours per week
Start Date - April/May 2025
If you would like to be considered, please apply now to arrange for a confidential discussion with one of our recruiters!
