Engineer - Computer Systems Validation & IT Compliance

At Bristol Myers Squibb, our employees often ask, “Who are you working for?”—a question that fuels collaboration, accountability, and urgency in our work. Our purpose-driven culture inspires us to discover, develop, and deliver innovative medicines to prevail over serious diseases. We offer uniquely interesting and meaningful work, opportunities for growth, and a supportive environment that values inclusion, wellbeing, flexibility, and comprehensive benefits. This is work that transforms the lives of patients, and the careers of those who do it.

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.

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,