Equipment CQV Engineer

Equipment CQV Engineer

Role:

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 of equipment in a regulated GMP environment.

Key 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.

Required:

• 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 for manufacturing and/or laboratory equipment.

• Ability to review protocols, execute testing, document results, and address discrepancies/deviations.

• Understanding GMP documentation and good documentation practices.