Validation Engineer

Job Summary

To support validation processes, the full-time Validation Engineer will develop and execute validation protocols, ensuring quality performance and compliance while working onsite in Boston, Massachusetts.

Key Responsibilities

• Generate and execute life cycle documentation for cleaning, shipping, facilities, utilities, systems, equipment, and processes
• Support validation activities for Tech Transfer projects, including the generation and execution of validation life cycle documents
• Write and review various qualification-related documents, including SOPs, validation master plans, and commissioning test procedures

Required Qualifications

• Bachelor's degree in a related life science field
• 3-10 years of experience in the biotech, pharmaceutical, or medical device industry
• Knowledge of FDA cGMP, FMEA, and Risk Analysis
• Validation expertise in Equipment, CSV, Method, and Process
• Experience in report writing for IQ, OQ, PQ, and CSV