Equipment CQV Engineer

About the Role

We are seeking experienced Equipment CQV Engineers to support an onsite GMP equipment qualification program at a biopharmaceutical manufacturing facility. The role focuses on hands-on execution of equipment commissioning and qualification activities across manufacturing, laboratory, and support equipment in a regulated GMP environment.

Responsibilities

• Review and execute established equipment qualification protocols (IQ/OQ).
• Document test results and identify/resolve execution issues.
• Support equipment readiness for manufacturing and engineering activities.
• Qualify various manufacturing, laboratory, and support equipment.
• Partner with Engineering, Validation, Manufacturing, Quality, and equipment vendors.
• Work independently, moving quickly through multiple equipment packages.

Requirements

• 5–10 years of CQV, equipment validation, or equipment qualification experience.
• Strong hands-on experience executing IQ/OQ and other equipment qualification protocols.
• Pharmaceutical, biotechnology, biopharmaceutical, cell therapy, or other GMP-regulated manufacturing experience.
• Experience qualifying manufacturing and/or laboratory equipment.
• Ability to review protocols, execute testing, document results, and address discrepancies/deviations.
• Understanding of GMP documentation and good documentation practices.