The CQV (Commissioning, Qualification & Validation) Engineer is responsible for planning, executing, and documenting commissioning, qualification, and validation activities for equipment, utilities, facilities, systems, and processes within a GMP-regulated pharmaceutical, biotechnology, or life sciences environment. The role supports projects from design through startup and qualification, ensuring systems meet approved specifications, regulatory requirements, and company quality standards. The CQV Engineer works closely with Engineering, Quality Assurance, Manufacturing, Automation, Validation, and vendors to develop and execute protocols, resolve discrepancies, complete documentation, and maintain inspection readiness.
- Approximately 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.
- Ability to review protocols, execute testing, document results, and address discrepancies or deviations encountered during execution.
- Understanding of GMP documentation and good documentation practices.
- 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.