Onsite CQV & Validation Engineer — Aseptic Fill/Finish

Katalyst CRO; Cincinnati (OH); On-site; Full time

Job description

Job Description

• Client is looking for onsite Validation Engineers / CQV Engineers to support upcoming qualification work tied to sterile manufacturing and fill/finish operations. The consultants will support hands‑on OQ/PQ execution, GMP documentation, protocol execution, discrepancy/deviation support, and equipment qualification activities.
• The ideal candidate will have direct validation engineering or CQV experience in a fast‑paced GMP environment, with strong exposure to fill line qualification, aseptic filling, sterile manufacturing equipment, and execution‑heavy validation work. Equipment experience with autoclaves, formulation equipment, fill suites, high‑velocity fillers, isolators, parts washers, tanks, and aseptic process systems is highly relevant.
• Experience with vision systems or automated inspection systems is a strong plus, especially for candidates who have worked around high‑speed fill lines or aseptic manufacturing lines. Candidates should be able to work independently onsite, execute protocols accurately, document in real time, identify discrepancies, and help drive qualification deliverables through completion.

Requirements

• Bachelor’s degree in Engineering, Life Sciences, or a related technical discipline preferred. Equivalent hands‑on validation/CQV experience in GMP manufacturing environments can be considered.
• 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 Skills

• 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.