CQV Engineer

Job Title : CQV Engineer

Location : San Francisco, CA / Vacaville, CA (Onsite)

Key Responsibilities :

• Lead and execute Commissioning, Qualification, and Validation (CQV) protocols for systems, utilities, and equipment in compliance with GMP standards.
• Prepare, review, and execute documentation including URS, FAT, SAT, IQ, OQ, and PQ.
• Oversee commissioning and qualification of essential biotech process systems such as bioreactors, chromatography skids, CIP / SIP units, autoclaves, and clean utilities.
• Collaborate closely with engineering, automation, and operations teams to ensure systems are fully qualified and production-ready.
• Perform risk assessments, change controls, and impact analyses to maintain compliance.
• Generate and maintain high-quality validation documentation and reports for regulatory audits.
• Drive CQV project deliverables on schedule while maintaining a culture of quality and safety.

Qualifications :

Nice to Have :