Senior CQV Engineer

Global Compliance Partners is hiring a Senior CQV Engineer for a major cell therapy capacity expansion at a leading biopharma manufacturing site in the Greater Seattle area. The program runs multiple concurrent projects taking new suites, utilities, and process equipment from installation through GMP release.

This is hands-on qualification work on some of the most interesting equipment in the industry, at a site that is actively launching product.

• Author and execute qualification deliverables across the full lifecycle: qualification plans, system level impact assessments, system requirements, DQ, component and design specifications, IOQ, PQ, traceability matrices, and qualification summary reports.
• Execute commissioning deliverables for utilities and rooms:
  Cx plans, installation verification, operational verification, performance verification, and turnover packages.
• Own qualification for single-use ATMP COTS equipment, leveraging vendor IOQ packages and developing wrapper protocols where appropriate.
• Support clean utility C&Q including LN2 expansion, CO2, and clean compressed air, plus BAS point additions.
• Support classified room commissioning and qualification for suite, airlocks, cryo, and material transfer spaces.
• Execute protocols electronically in Val Genesis, following good documentation practices, and manage deviations and discrepancies to closure.
• Participate in daily scrum via JIRA with system owners, quality, and validation support teams, and keep deliverables moving inside a five business day review and approval cycle.
• Coordinate with engineering, MSAT, QA, and manufacturing operations to sequence work around live production

• 7+ years of hands-on experience in CQV within biopharma or advanced therapies.
• Demonstrated experience validating utilities, QC laboratory systems and GMP manufacturing systems.
• Strong knowledge of FDA, EMA, and ICH regulations with emphasis on 21 CFR Part 11 and Annex 11.
• Familiarity with Valgenesis and Veeva platforms.