Job Description
Job Title: CQV Engineer
Location: San Francisco, California
Long-Term Project
Key Responsibilities
- Lead commissioning of impact and non-impact utility systems, including:
- Industrial Water, Sanitary Waste, Refrigerated Water & Distribution
- WFI & AWFI generation systems, pretreatment skids, WFI storage tanks
- Autoclaves, Clean Steam & Clean Air Distribution
- AHUs supporting Grade B & C cleanrooms
- Ensure compliance with GMP, FDA/EMA regulations, and client PQS.
- Apply ASTM E2500 and Quality Risk Management (QRM) principles.
- Prepare and review commissioning documentation: plans, protocols, test scripts, reports, and turnover packages.
- Support inspection readiness, audits, start-up, troubleshooting, and system handover.
- Collaborate with engineering, validation, quality, automation, facilities, and operations teams.
Qualifications
- Bachelor’s degree in mechanical, chemical, or related engineering field.
- 8+ years of pharmaceutical commissioning experience.
- Strong experience with GMP utilities and cleanroom HVAC systems.
- Knowledge of GMP, PQS, risk management, and regulatory compliance.
- CCP certification preferred.
- Strong communication and documentation skills.