Sr Engineer Computer Systems Validation

Role: Senior Engineer, IT Compliance and CSV, supporting computerized system validation, IT compliance, and change management at Bristol Myers Squibb's Devens Campus, including the Cell Therapy Facility. Responsibilities: execute CSV activities, serve as SME on computerized system changes, support deviation, audit, change, and risk management programs, guide digital plant teams, and ensure GxP compliance; develop procedures, support audits, and track project progress to improve CSV processes. Qualifications: Bachelor's in Engineering, Science, IT, or related field; 3-5 years in CSV, compliance, or regulated biotech/biologics environments, with knowledge of FDA, EMA, GAMP, and Data Integrity; experience in Cell & Gene Therapy or biologics manufacturing preferred. HighValue: CSV for regulated IT systems supporting cell therapy and biologics manufacturing, GxP compliance, regulatory audits, risk management, and cross-functional collaboration within a regulated biopharma setting. WorkSetup: on-site at Devens, with potential for site-specific occupancy requirements.