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| Advertiser Name | Warman OBrien | | Advertiser Type: | Agency |
| Classification: | 6227 | | Subclassification: | |
| Country: | United States | | Location: | United States |
| Language: | English - United Kingdom (en-GB) | | Contact Name: | |
| Employment Type: | Permanent | | Workhours: | Full Time |
Position: Commissioning & Qualification Lead - Bioprocessing Equipment |
Description:
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!
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