Validation Engineer
Job in
Boston, Suffolk County, Massachusetts, 02298, USA
Listed on 2026-10-29
Listing for:
Katalyst-Healthcares-
Full Time
position Listed on 2026-10-29
Job specializations:
-
Engineering
Validation Engineer, Quality Engineering, Biomedical Engineer, Pharma Engineer
Job Description & How to Apply Below
We are Seeking a Validation Engineer to support the development and execution of validation protocols across processes, equipment, utilities, and systems, ensuring compliance with cGMP and regulatory standards.
Roles & Responsibilities :- Generate and execute lifecycle documentation (FAT, SAT, IOQ, PQ) for equipment, facilities, and processes
- Write, review, and revise validation protocols, SOPs, master plans, and technical documents
- Support validation activities including execution, review, and closure of lifecycle documents
- Perform Pamp;, drawing reviews, ETOP verification, and thermal mapping of chambers
- Assist with regulatory observations, periodic reviews, and requalification activities
- Bachelor's degree in Life Sciences, Engineering, or related discipline
- 2–5yrs of validation/engineering experience in biotech, pharma, or medical device industry
- Knowledge of FDA cGMP, FMEA, and Risk Analysis
- Experience with process equipment, utilities, clean room, and/or computer systems validation
- Strong technical writing and communication skills
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