Sr Engineer Computer Systems Validation

Role: Senior Engineer in IT Compliance and CSV supporting regulated computerized systems at Bristol Myers Squibb's Devens Campus, including the Cell Therapy Facility. Responsibilities: execute system validation, serve as CSV SME, support deviation, audit, change, and risk management programs; advise on CSV process implementation; support Data Integrity and Quality Risk Management initiatives; participate in audits and generate regulatory responses; develop GxP documentation, track project progress, and identify process improvements. Qualifications: Bachelor's in Engineering, Science, or IT with 3-5 years in Compliance and CSV, preferably in Cell Therapy, Biologics, or life sciences; detailed knowledge of FDA/EMA regulations, GAMP, 21 CFR Part 11, Data Integrity, and validated automated systems; experience with quality systems, audit support, risk management, and working cross-functionally. High-Value: regulated IT systems in cell therapy or biologics manufacturing, GxP compliance, FDA/EMA regulations, validation activities, audit readiness, and risk management. WorkSetup: primarily on-site at Devens with site- and role-specific flexibility.