Commissioning & Qualification Engineer
On-site · Lexington, Kentucky, United States
Job Summary
Commissioning & Qualification Engineer to support startup, testing and qualification of GMP sterile manufacturing systems and utilities at the Lexington, KY facility. Responsibilities include developing and executing commissioning test plans and IQ/OQ protocols, coordinating testing with engineering, quality, and operations teams, assisting with equipment installation verification and turnover, troubleshooting during commissioning/qualification, reviewing vendor documentation and P&IDs, and supporting GMP documentation for regulatory readiness. Project scope includes sterile filling lines, lyophilizers, vial washing/sterilization systems, isolators and aseptic processing equipment, clean utilities (WFI, clean steam, process gases), HVAC and environmental control systems, packaging and supporting production equipment. Qualifications include a Bachelor’s degree in Engineering or related discipline and 2–5 years of commissioning/qualification/validation experience in GMP environments; sterile manufacturing experience is preferred. Strong ability to read engineering drawings and system design documentation; excellent cross-functional collaboration skills are required.
Required Qualifications
- Bachelor’s degree in Engineering or related technical discipline
- 2 - 5 years of experience in commissioning, qualification, or validation
- Experience working in GMP regulated manufacturing environments
- Experience with sterile manufacturing or aseptic processing preferred
- Ability to read engineering drawings, P&IDs, and system design documentation
- Strong communication skills and ability to work within multi-disciplinary project teams
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