CQV Engineer Job at Staftonic LLC, San Francisco, CA

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  • Staftonic LLC
  • San Francisco, CA

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.

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