Engineer, IT Compliance, Devens Cell Therapy Facility

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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 rich in diversity. Take your career farther than you thought possible.

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Position Summary:

• The Engineer - IT Compliance, Cell Therapy at Devens Cell Therapy Facility (CTF) will support the development, implementation, and maintenance of IT/Automation (Digital Plant) processes and ensure the group's adherence to System Life Cycle standards. This role will primarily support the IT Compliance, IT Deviation Management, Computer System Audit, Change Management, Training Management, and the Risk Management Programs at the Devens CTF.

Duties/Responsibilities:

• Supports IT Compliance, IT Deviation Management Program, Computer System Audit, Change Management, Training Management, and Risk Management Programs at the Devens CTF.
• Acts as a CSV Subject Matter Expert (SME) for computerized system related changes and associated IT/Automation projects. This may include developing and executing validation plans, protocols (IQ, OQ, PQ), and reports for computer systems and software applications used in GxP environments.
• Collaborates with cross-functional teams, including IT, Manufacturing Sciences and Technology, Quality Assurance, Manufacturing, and Laboratory, to ensure successful validation of systems.
• Supports regulatory audits and internal audits as a Digital Plant representative, responsible for inspections readiness and finding responses.
• Interacts with Veeva Vault (Quality Management System) to enter deviations and associated actions, investigations and associated root cause analysis, supporting data, corrective action/preventative action (CAPA) and effectiveness checks as needed.
• Provides IT compliance support to Devens CTF Digital Plant team through owning or supporting investigations and change controls, deviation ownership of computerized system events, and CSV activities.
• Provides support to maintaining quality system compliance against established KPIs for the Devens CTF Digital Plant team
• Provides compliance support of Digital Plant programs and system maintenance activities.
• Ensures that Digital Plant standard operating procedures (SOPs) and procedural methodologies employed to maintain the validated state are regularly reviewed and updated, as needed.

Reporting Relationship:

• This position will report into the Devens CTF Site Sr. Manager of IT Quality and Compliance

Qualifications:

• Strong knowledge of regulatory requirements and industry standards related to computer system validation (CSV) requirements (e.g., FDA, EMA, GAMP 5, 21 CFR Part 11, Annex 11) as they apply to Cell & Gene Therapy or Biologics manufacturing.
• Experience with Quality principles and QA methodologies, including ISO 9001 and ICH guidelines (e.g., Q7, Q9, Q10).
• Experience working with global policies/procedures, CGMP requirements, and regulatory guidelines, demonstrating the ability to work within a regulated environment for a fully automated, multi-product, Cell Therapy manufacturing facility.
• Experience in implementing and supporting quality systems including risk management, audit readiness, deviation management, training management, and change management programs.
• Strong in project management, verbal communication, and technical writing skills.
• Proficiency using electronic quality management systems, such as Veeva Vault Quality.
• Knowledge of data integrity principles and practices.

Preferred Qualifications:

• Experience working with Manufacturing Execution Systems (Syncade), Process Automation Systems (DeltaV), and Benchtop IT Systems.
• Experience with Lean Six Sigma and Operational Excellence.
• Experience developing and applying new and innovative approaches to projects and processes.

Education/Experience/Licenses/Certifications:

• Engineering and science experience generally attained through studies resulting in a B.S. in Engineering, Sciences, or a related IT/OT discipline or its equivalent.
• A minimum of 2 years of the above relevant experience preferably in the Cell Therapy or life sciences area is required.

If you come across a role that intrigues you but doesn't perfectly line up with your resume, we encourage you to apply anyway. You could be one step away from work that will transform your life and career.

Uniquely Interesting Work, Life-changing Careers
With a single vision as inspiring as "Transforming patients' lives through science ", every BMS employee plays an integral role in work that goes far beyond ordinary. Each of us is empowered to apply our individual talents and unique perspectives in an inclusive culture, promoting diversity in clinical trials, while our shared values of passion, innovation, urgency, accountability, inclusion and integrity bring out the highest potential of each of our colleagues.

On-site Protocol

BMS has a diverse occupancy structure that determines where an employee is required to conduct their work. This structure includes site-essential, site-by-design, field-based and remote-by-design jobs. The occupancy type that you are assigned is determined by the nature and responsibilities of your role:

Site-essential roles require 100% of shifts onsite at your assigned facility. Site-by-design roles may be eligible for a hybrid work model with at least 50% onsite at your assigned facility. For these roles, onsite presence is considered an essential job function and is critical to collaboration, innovation, productivity, and a positive Company culture. For field-based and remote-by-design roles the ability to physically travel to visit customers, patients or business partners and to attend meetings on behalf of BMS as directed is an essential job function.

BMS is dedicated to ensuring that people with disabilities can excel through a transparent recruitment process, reasonable workplace accommodations/adjustments and ongoing support in their roles. Applicants can request a reasonable workplace accommodation/adjustment prior to accepting a job offer. If you require reasonable accommodations/adjustments in completing this application, or in any part of the recruitment process, direct your inquiries to adastaffingsupport@bms.com. Visit careers.bms.com/eeo-accessibility to access our complete Equal Employment Opportunity statement.

BMS cares about your well-being and the well-being of our staff, customers, patients, and communities. As a result, the Company strongly recommends that all employees be fully vaccinated for Covid-19 and keep up to date with Covid-19 boosters.

BMS will consider for employment qualified applicants with arrest and conviction records, pursuant to applicable laws in your area.

If you live in or expect to work from Los Angeles County if hired for this position, please visit this page for important additional information: https://careers.bms.com/california-residents/

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