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Agent guide: [/agents.md](https://www.wearedevelopers.com/agents.md). --- # Engineer - Computer Systems Validation & IT Compliance - **Company:** Bristol Myers Squibb - **Location:** Devens, MA, United States - **Experience:** Starter - **Salary:** $84,150.0 - $101,970.0 - **Contract:** Permanent contract - **Skills:** Data Integrity, Digital Assets, Information Technology Audit, System Testing, Information Technology, GXP - **Published:** September 12, 2026 - **Apply:** https://www.indeed.com/viewjob?jk=fdd5ceb04a0030ce ## About the Role * Bachelor's degree in Engineering, Science, Information Technology, or a related IT/OT discipline, with a minimum of 1-3 years of relevant experience in Compliance and Computer System Validation (CSV), preferably including Cell Therapy, Biologics Manufacturing, or related life sciences experience. * Experience/training in performing internal audits/inspections is not mandatory, but would be an advantage * Working knowledge of regulatory computer system validation requirements, including FDA, EMA, and applicable global requirements (e.g., ICH Q7, Q8, Q9), particularly as applied to Cell & Gene Therapy or Biologics manufacturing. * Working knowledge of 21 CFR Part 11, 21 CFR Parts 210/211, GAMP, for validation of automated systems (working knowledge of the ISO 9001 standard is a plus). * Working knowledge of health authority requirements and regulatory issues pertaining to digital assets, including Data Integrity. * Exposure to or developing experience supporting quality systems, risk management, audit readiness, deviation management, and change management within a fully automated, regulated manufacturing environment. * Developing ability to represent the department before stakeholders and management, with growing exposure to external regulatory agencies. * Willingness to support interactions with US FDA and other regulatory agencies under the guidance of senior staff, as needed. * Good project management, communication, and technical writing skills. * Willingness to support the development of training materials and assist in conducting training * Working understanding of Lean Six Sigma and OPEX principles. * Ability to develop and apply innovative approaches to projects and processes. * Ability to understand business needs and synthesize solutions across functions. * Strong collaboration and cross-functional skills to support continuous improvement, promote knowledge sharing, and implement best practices across the network. * Communicates effectively across different levels of the business; exercises sound judgment within established practices and procedures, escalating to management when necessary. * Ability to work in a dynamic work environment and manage multiple priorities. Eagerness to learn from senior team members and contribute to knowledge-sharing within the team. * ## Description * Execute assigned computer system validation (CSV) and IT compliance activities, including in support of the in alignment with team and site objectives. * Support Computer System Validation (CSV) activities for computerized system changes and associated IT/Automation projects, escalating complex CSV matters to senior team members as needed. * Support the IT Deviation Management, Computer System Audit, Change Management, and Risk Management programs at the site. * Support Digital Plant and site functional groups with CSV process implementation; participate in analyzing process deficiencies under the direction of senior staff. * Support the BMS Data Integrity and Quality Risk Management programs. * Provide IT quality support through review of investigations and change controls, supporting deviation resolution of computerized system events, and CSV activities. * Enter and support deviations, associated actions, root cause analysis, corrective/preventative actions (CAPA), and effectiveness reviews within the Quality Management System, as needed. * Participate in regulatory and internal audits/inspections as a Digital Plant representative and help generate timely responses to audit observations. * Support the implementation and tracking of Service Level Agreements (SLA) for supported business-critical activities. * Develop and maintain procedures, guidance documents, and other GxP-related documents in a high state of compliance and audit readiness. * Execute validation, implementation, and change management activities for regulated IT systems in compliance with applicable regulatory requirements. * Track assigned project progress to meet schedules, maximize productivity, reduce costs, and increase efficiencies; provide updates to management through established tools and dashboards. * Identify opportunities to improve the efficiency and quality of CSV documentation and processes, and evaluate new technologies, tools, and process improvements., Where you work matters - because collaboration, innovation and patient impact happen in many settings. Our roles are structured across four work models: site-essential, site-by-design, field-based and remote-by-design. The model assigned to this role is based on its core responsibilities. Learn more at https://careers.bms.com/ways-of-working. Supporting People with Disabilities BMS is dedicated to ensuring that people with disabilities can excel through a transparent recruitment process, reasonable workplace accommodations/adjustments and ongoing support in their roles. Applicants can request a reasonable workplace accommodation/adjustment prior to accepting a job offer. If you require reasonable accommodations/adjustments in completing this application, or in any part of the recruitment process, direct your inquiries to adastaffingsupport@bms.com . Visit careers.bms.com/eeo-accessibility to access our complete Equal Employment Opportunity statement. 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