Sr Engineer Computer Systems Validation

Bristol-Myers Squibb; United States; On-site; USD 120,000 - 150,000; Full time

Job summary

Bristol Myers Squibb seeks a Senior Engineer, IT Compliance and CSV to support validated, regulated computerized systems at the Devens Campus, including the Cell Therapy Facility (CTF). You will implement CSV practices and collaborate with Quality, Validation, Manufacturing, and enterprise teams.

The role requires hands-on experience with CSV, IT compliance, and risk management in a fully automated manufacturing environment, plus strong writing and communication skills.

Qualifications

• Minimum of 3-5 years of relevant experience in Compliance and CSV, preferably including Cell Therapy or Biologics Manufacturing.
• Solid knowledge of regulatory computer system validation requirements (FDA/EMA) and global requirements.
• Experience with 21 CFR Part 11, 21 CFR Parts 210/211, and GAMP.

Responsibilities

• Execute CSV and IT compliance activities for Devens Cell Therapy Facility (CTF) in alignment with site objectives.
• Serve as CSV SME for computerized system changes and advise operations on CSV matters.
• Support IT Deviation Management, Computer System Audit, Change Management, and Risk Management programs at the site.
• Provide guidance to Digital Plant and site functional groups on CSV processes; analyze process deficiencies.
• Track project progress and provide updates to management through dashboards.

Skills

CSV expertise

Regulatory compliance

Project management

Technical writing

Communication skills

Education

Bachelor's degree in Engineering/Science/IT or related IT/OT

Tools

Quality Management Systems

Job description

Working with Us

Challenging. Meaningful. Life-changing. Those aren't words that are usually associated with a job. But working at Bristol Myers Squibb is anything but usual. Here, uniquely interesting work happens every day, in every department. From optimizing a production line to the latest breakthroughs in cell therapy, this is work that transforms the lives of patients, and the careers of those who do it. You'll get the chance to grow and thrive through opportunities uncommon in scale and scope, alongside high-achieving teams. Take your career farther than you thought possible.

Bristol Myers Squibb recognizes the importance of balance and flexibility in our work environment. We offer a wide variety of competitive benefits, services and programs that provide our employees with the resources to pursue their goals, both at work and in their personal lives. Read more: careers.bms.com/working-with-us .

Position Summary

The Senior Engineer, IT Compliance and CSV, supports computerized system validation, IT compliance, and change/deviation management for regulated computerized systems across the Devens Campus, including the Cell Therapy Facility (CTF). This role executes System Life Cycle deliverables, serves as a CSV subject matter expert for computerized system changes, and supports the IT Deviation Management, Computer System Audit, Change Management, and Risk Management programs. The Senior Engineer works collaboratively with Quality, Validation, Manufacturing, Engineering, and enterprise teams, and interfaces with global compliance and validation initiatives, serving as a site delegate as needed.

Duties/Responsibilities

• Execute assigned computer system validation (CSV) and IT compliance activities, including in support of the Devens Cell Therapy Facility (CTF), in alignment with team and site objectives.
• Serve as a Computer System Validation (CSV) subject matter expert (SME) for computerized system changes and associated IT/Automation projects, advising operations on CSV matters.
• Support the IT Deviation Management, Computer System Audit, Change Management, and Risk Management programs at the site.
• Provide guidance to Digital Plant and site functional groups on CSV process implementation; participate in analyzing and addressing process deficiencies.
• Support the BMS Data Integrity and Quality Risk Management programs.
• Provide IT quality support through review and approval of investigations and change controls, deviation ownership 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.

Qualifications

• Bachelor's degree in Engineering, Science, Information Technology, or a related IT/OT discipline, with a minimum of 3-5 years of relevant experience in Compliance and Computer System Validation (CSV), preferably including Cell Therapy, Biologics Manufacturing, or related life sciences experience.
• Solid 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 and ISO 9001 standard is a plus).
• Working knowledge of health authority requirements and regulatory issues pertaining to digital assets, including Data Integrity.
• Experience implementing and supporting quality systems, risk management, audit readiness, deviation management, and change management within a fully automated, regulated manufacturing environment.
• Demonstrated ability to represent the department before stakeholders, external regulatory agencies, and management.
• Ability to support interactions with US FDA and other regulatory agencies, as needed.
• Strong project management, communication, and technical writing skills.
• Past experience in developing training mater