Engineer - Computer Systems Validation & IT Compliance

Role: Computer Systems Validation (CSV) & IT Compliance Engineer supporting GxP-regulated manufacturing environments, with focus on Cell Therapy and Biologics production. Responsibilities: execute and support CSV activities, including validation, change control, deviation management, risk assessment, and audit readiness for regulated IT systems; support Data Integrity and Quality Risk Management programs; develop procedures and maintain compliance documentation; participate in audits and inspections; identify process improvements and implement new technologies. Requirements: Bachelor’s in Engineering, Science, IT, or related discipline; 1-3 years of experience in CSV and compliance within regulated life sciences manufacturing, preferably in Cell & Gene Therapy or Biologics; knowledge of FDA/EMA regulations, 21 CFR Part 11, GAMP, and Data Integrity standards; familiarity with validation of automated systems and quality systems; project management, communication, and technical writing skills; willingness to support interactions with regulatory agencies. Preferred: experience supporting validation in biologics or cell therapy environments, exposure to risk management and audit processes, working knowledge of Lean Six Sigma and OPEX principles. HighValue: CSV for regulated IT systems in cell/gene therapy or biologics manufacturing; regulatory compliance, audit support, Data Integrity; support for digital plant initiatives; validation lifecycle management. WorkSetup: location unspecified; likely on-site or hybrid based on manufacturing site needs.