5-10 years of CQV, equipment validation, or equipment qualification experience
Hands-on experience with IQ/OQ and equipment qualification protocols
Background in pharmaceutical, biotechnology, or biopharmaceutical manufacturing
Experience qualifying manufacturing and laboratory equipment
Proficient in reviewing protocols and documenting test results
Familiarity with GMP documentation and best practices
Responsibilities
Support onsite GMP equipment qualification program
Conduct hands-on commissioning and qualification activities
Review and execute established qualification protocols
Document test results and identify execution issues
Collaborate with Engineering, Validation, Manufacturing, Quality, and equipment vendors
Ensure equipment readiness for manufacturing and engineering activities
Benefits
Opportunity to work in a regulated GMP environment
Hands-on experience within a biopharmaceutical manufacturing facility
Collaboration with a diverse range of professionals
Potential for quick advancement through multiple equipment packages
Engagement in meaningful work that ensures quality in biopharmaceutical processes
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.
