Validation Engineer / CQV Engineer
Katalyst CRO · Cincinnati, OH · 1 mo ago
On-siteEngineeringContract
Responsibilities
- Support hands-on OQ/PQ execution
- Create and maintain GMP documentation
- Execute and document protocols accurately
- Identify and resolve discrepancies and deviations
- Drive qualification deliverables through completion
Requirements
- Bachelor's degree in Engineering, Life Sciences, or a related technical discipline
- Equivalent hands-on validation/CQV experience in GMP manufacturing environments
Must Have
- Hands-on validation engineering or CQV experience
- Strong OQ/PQ execution and documentation background
- Fill/finish, aseptic filling, or fill line qualification experience
- Sterilization or sterile manufacturing equipment experience
- GMP documentation experience
- Protocol execution experience
- Deviation/discrepancy support experience
- Ability to work independently in a fast-paced project environment
- Experience supporting equipment qualification in a regulated life sciences environment
Strong Plus
- Aseptic Fill/Finish Equipment Experience: Exposure to isolators, high-velocity fillers, formulation equipment, fill suites, parts washers, tanks, and autoclaves.
- Sterilization / Sterile Manufacturing Systems: Experience with SIP, VHP, autoclaves, and sterile equipment qualification.
- Vision / Inspection System Experience: Background with vision systems or automated inspection systems, especially tied to aseptic filling or high-speed manufacturing lines.
- Validation Tools / Execution Support: Experience using Kaye validators, wireless probes, and supporting hands-on protocol execution.
- Documentation & Closeout: Strong ability to document execution in real time, manage discrepancies, and support protocol package closeout.