Validation Engineer / CQV Engineer

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.