Position SummaryThe 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 materials and 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.
• Experience/training in performing internal audits/inspections is not mandatory, but would be an advantage
• Willingness to mentor junior team members and contribute to knowledge-sharing within the team.
Compensation Overview:Devens - MA - US: $99,480 - $120,551
The starting compensation range(s) for this role are listed above for a full-time employee (FTE) basis. Additional incentive cash and stock opportunities (based on eligibility) may be available. The starting pay rate takes into account characteristics of the job, such as required skills, where the job is performed, the employee's work schedule, job-related knowledge, and experience. Final, individual compensation will be decided based on demonstrated experience.
Eligibility for specific benefits listed on our careers site may vary based on the job and location. For more on benefits, please visit https://careers.bms.com/life-at-bms/.
Benefit offerings are subject to the terms and conditions of the applicable plans in effect at the time and may require enrollment. Our benefits include:
- Health Coverage: Medical, pharmacy, dental, and vision care.
- Wellbeing Support: Programs such as BMS Well-Being Account, BMS Living Life Better, and Employee Assistance Programs (EAP).
- Financial Well-being and Protection: 401(k) plan, short- and long-term disability, life insurance, accident insurance, supplemental health insurance, business travel protection, personal liability protection, identity theft benefit, legal support, and survivor support.
Work-life benefits include:Paid Time Off
- US Exempt Employees: flexible time off (unlimited, with manager approval, 11 paid national holidays (not applicable to employees in Phoenix, AZ, Puerto Rico or Rayzebio employees)
- Phoenix, AZ, Puerto Rico and Rayzebio Exempt, Non-Exempt, Hourly Employees: 160 hours annual paid vacation for new hires with manager approval, 11 national holidays, and 3 optional holidays
Based on eligibility*, additional time off for employees may include unlimited paid sick time, up to 2 paid volunteer days per year, summer hours flexibility, leaves of absence for medical, personal, parental, caregiver, bereavement, and military needs and an annual Global Shutdown between Christmas and New Years Day.
All global employees full and part-time who are actively employed at and paid directly by BMS at the end of the calendar year are eligible to take advantage of the Global Shutdown.
*Eligibility Disclosure: The summer hours program is for United States (U.S.) office-based employees due to the unique nature of their work. Summer hours are generally not available for field sales and manufacturing operations and may also be limited for the capability centers. Employees in remote-by-design or lab-based roles may be eligible for summer hours, depending on the nature of their work, and should discuss eligibility with their manager. Employees covered under a collective bargaining agreement should consult that document to determine if they are eligible. Contractors, leased workers and other service providers are not eligible to participate in the program.
