CQV Engineer
Intellectt INCSan Francisco, CA, United States5 days ago
Job type
- Full-time
- Quick Apply
Job descriptionBachelor's degree in Engineering, Biotechnology, Chemical Engineering, or related field. 5 6 years of hands-on CQV experience within pharmaceutical or biotech manufacturing. In-depth knowledge of GMP, FDA, and related regulatory requirements. Strong understanding of ISPE Baseline Guides, ASTM E2500, and CQV lifecycle principles. Experience with biotech manufacturing systems (upstream / downstream). Knowledge of automation systems and data integrity practices. Familiarity with Vacaville or Bay Area biotech operations.
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 :
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Engineer • San Francisco, CA, United States