2h ago

CQV Engineer

Italy

$55k-$75k / yearest.

full-timemid HybridLife Sciences

🛠 Tech Stack

💼 About This Role

You'll join CAI's growing operations in Italy as a CQV Engineer, developing documentation for commissioning, qualification, and validation of pharmaceutical facilities and equipment. You'll be responsible for protocol writing, field verification, and summary reports at client sites.

🎯 What You'll Do

  • Write and execute qualification protocols (IQ/OQ/PQ)
  • Perform field verification and system walkdowns
  • Develop summary reports for CQV activities
  • Support FATs, SATs, and system startups

📋 Requirements

  • BS or MS in science or engineering
  • 4-8 years commissioning/qualification in FDA regulated industry
  • Experience with facilities, utilities (WFI, RO, HVAC), and equipment startup
  • Proficiency in cGMP and life sciences manufacturing processes

✨ Nice to Have

  • Familiarity with Baseline Guide 5 (Second Edition)
  • Experience with isolators qualification and VHP cycle development

🚩 Heads Up

  • Requires European citizenship or valid residence permit, limiting applicant pool
  • Mentions extensive general management skills not typically expected for an engineer
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