Generate and execute lifecycle documentation (FAT, SAT, IOQ, PQ) for equipment, facilities, and processes. Perform Pamp;ID walkdowns, drawing reviews, ETOP verification, and thermal mapping of chambers.
Numbers & Facts
Location
Boston, MA
Description
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.
Bachelor's degree in Life Sciences, Engineering, or related discipline
2-3 yrs 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
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;ID walkdowns, drawing reviews, ETOP verification, and thermal mapping of chambers
Assist with regulatory observations, periodic reviews, and requalification activities