Job Details

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.