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.
Responsibilities
- ✓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.
Requirements
- ✓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.
We hire for skills and capabilities, not just credentials – if this role excites you, but doesn’t perfectly match your resume, we encourage you to apply anyway.
Compensation Overview
Devens - MA - US: $84,150 - $101,970