What are the responsibilities and job description for the Equipment CQV Engineer position at Stark Pharma Solutions Inc?
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.