5-10 years of direct CQV, equipment validation, or qualification experience
Strong hands-on execution of IQ/OQ qualification protocols
Experience in pharmaceutical, biotechnology, or biopharmaceutical GMP environments
Proven ability to qualify both manufacturing and laboratory equipment
Skilled in reviewing protocols and documenting test results
Familiarity with GMP documentation and good documentation practices
Responsibilities
Execute equipment commissioning and qualification activities on-site
Review and execute established qualification protocols
Document test results accurately and promptly
Identify and resolve execution issues during equipment qualification
Support equipment readiness for manufacturing and engineering operations
Collaborate with multidisciplinary teams including Engineering, Validation, and Quality
Quickly move through multiple equipment qualification packages
Benefits
Opportunity to work in a cutting-edge biopharmaceutical manufacturing facility
Hands-on experience with diverse types of manufacturing and laboratory equipment
Collaboration with a variety of industry professionals and vendors
Engagement in a regulated GMP environment ensuring high standards of quality
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.
