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CQV Engineer

Job description

CQV Engineer – Contract Opportunity

A leading biopharma project is seeking an experienced CQV Engineer to support a fast-paced commissioning, qualification, and validation (CQV) program within a GMP drug substance manufacturing environment.

Key Responsibilities:

  • Deliver full CQV lifecycle documentation (URS, DQ, FAT/SAT, IQ/OQ, PQ).

  • Commission and qualify bioprocess equipment and utilities (e.g. bioreactors, CIP/SIP, WFI, clean steam).

  • Collaborate cross-functionally to manage deviations, resolve issues, and ensure system readiness.

  • Apply risk-based approaches (e.g. ASTM E2500) and maintain GMP-compliant documentation.

Requirements:

  • 5+ years’ CQV experience in GMP biologics or drug substance facilities.

  • Expertise with large-scale bioprocess systems and utility qualification.

  • Strong knowledge of GAMP 5, ISPE Baseline Guides, and DeltaV-integrated systems.

  • Able to work independently across all stages of CQV.

Contract Role | Competitive Day Rate

Get in touch with Eanna (eanna.greally@forcerecruitment.com) to discuss this opportunity and join a high-impact project from construction through to GMP handover.