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
The starting pay range(s) listed above is for full-time employees (FTE). You may also be eligible for additional discretionary incentive cash and stock opportunities. We determine starting pay thoughtfully - carefully considering the nature of the role, required skills, work location, schedule and the knowledge and experience you bring. Final compensation is guided by pay equity principles and applicable employment laws. Compensation programs are reviewed on an ongoing basis and may be adjusted over time to reflect evolving market factors, and individual, team or Company performance.
Benefits:Subject to the terms and conditions of the applicable plans then in effect, you may be eligible to participate in our comprehensive benefit plans - including wellbeing support, retirement and financial protection benefits, and insurance offerings (medical, dental, vision, life and disability).
U.S.-based exempt employees are eligible for Flexible Time Off (FTO), which provides paid time off without a set accrual limit, subject to manager approval, along with 11 paid company holidays each year.
Non-exempt employees, RayzeBio employees, and employees located in Puerto Rico receive 160 hours of paid vacation annually for new hires (subject to manager approval), 11 paid company holidays, and 3 optional holidays.
Depending on eligibility, employees may also have access to additional time-off benefits, including paid sick leave, up to two paid volunteer days per year, summer hours flexibility, and leaves of absence for medical, personal, parental, caregiver, bereavement, or military needs. Eligible employees also enjoy an annual Global Shutdown between Christmas Day and New Year's Day.
U.S.-based job seekers can explore full benefit offerings at https://careers.bms.com/benefits
How We WorkWhere 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.
