Commissioning, Qualification, and Validation (CQV) Engineer

📋 Description

• Author and execute commissioning and qualification protocols — IQ, OQ and PQ — for utilities
• Perform field verification and walkdowns against P&IDs, and log discrepancies for resolution.
• Execute qualification sampling programs and maintain complete, accurate records — sample logs
• Write deviation reports and summary reports, and support investigations.
• Support risk assessments and FMEAs, and the sampling plans that follow from them.
• Support change control, and help close out qualification packages.

🎯 Requirements

• Two or more years of hands-on experience in a GMP-regulated environment, with direct involvement in
• A working understanding of IQ, OQ and PQ, and of why qualification documentation matters.
• Ability to read and work from technical drawings, particularly P&IDs.
• Clear technical writing. Much of this role is producing documents that a regulator may read.
• Familiarity with cGMP under 21 CFR Parts 210 and 211, and with good documentation practice.
• Degree in engineering, microbiology or a life science is preferred. Equivalent hands-on experience

🎁 Benefits

• Excellent full time benefits including comprehensive medical coverage, dental, and vision options
• Life and disability insurance
• 401(k) with company match
• Paid vacation and holidays