Engineer - Computer Systems Validation & IT Compliance

Role: Computer System Validation (CSV) Engineer supporting IT compliance and validation activities within a regulated biopharma manufacturing setting, particularly involving Cell Therapy, Biologics, or related life sciences. Responsibilities: execute and support CSV and IT compliance tasks, including change controls, deviation investigations, risk management, audit readiness, and document development; support Data Integrity and Quality Risk Management programs; participate in regulatory inspections and improve validation processes. Requirements: Bachelor's in Engineering, Science, or IT with 1–3 years' experience in CSV, regulated manufacturing, or digital systems; knowledge of FDA, EMA, ICH Q7/Q8/Q9, 21 CFR Part 11, GAMP, and Data Integrity; familiarity with cell/gene therapy or biologics manufacturing environments preferred. Skills: project management, technical writing, collaboration, and regulatory interaction readiness; supporting training and process improvements. HighValue: regulated IT validation, Data Integrity, Cell & Gene Therapy or biologics manufacturing, compliance with GxP and international standards, audit and inspection support, and cross-functional collaboration. WorkSetup: on-site in Devens, MA, with a focus on supporting digital plant systems and compliance activities.