Commissioning & Qualification Lead - Bioprocessing Equipment

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

Full Time