5-10 years of experience in CQV or equipment validation.
Hands-on experience with IQ/OQ qualification protocols.
Background in GMP-regulated environments such as biopharmaceuticals or cell therapy.
Proven track record of qualifying manufacturing and lab equipment.
Strong documentation skills for test results and compliance with GMP standards.
Responsibilities
Execute equipment commissioning and qualification activities.
Review and implement established qualification protocols.
Document test results and outcomes accurately.
Identify and resolve any issues during the qualification process.
Collaborate with cross-functional teams to ensure equipment readiness.
Benefits
Opportunity to work on-site in a cutting-edge biopharmaceutical facility.
Hands-on involvement with a variety of manufacturing and lab equipment.
Engagement with multiple departments including Engineering and Quality.
Possibility to influence equipment readiness and manufacturing effectiveness.
Full Job Description
Job Description:
Seeking experienced Equipment CQV Engineers to support an onsite GMP equipment qualification program at a biopharmaceutical manufacturing facility.
Consultants will be responsible for hands-on execution of equipment commissioning and qualification activities, including reviewing and executing established qualification protocols, documenting test results, identifying and resolving execution issues, and supporting equipment readiness for manufacturing and engineering activities.
The role will involve qualification of various manufacturing, laboratory, and support equipment in a regulated GMP environment.
Candidates should be comfortable working independently, moving quickly through multiple equipment packages, and collaborating with Engineering, Validation, Manufacturing, Quality, and equipment vendors.
Qualifications:
pproximately 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.
bility to review protocols, execute testing, document results, and address discrepancies or deviations encountered during execution.
Understanding of GMP documentation and good documentation practices.
