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;ID walkdowns, drawing reviews, ETOP verification, and thermal mapping of chambers
• Assist with regulatory observations, periodic reviews, and requalification activities
Education & Experience :
• Bachelor's degree in Life Sciences, Engineering, or related discipline
• 2–5 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
| Location | Boston, MA |
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