Senior Engineer, IT Computer System Validation (CSV)

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.

Summary:

The Senior Engineer, IT Computer System Validation, Cell Therapy Devens role will provide support to the Digital Plant team at the Devens Cell Therapy Facility (CTF) through managing the computerized system validation (CSV) activities / major projects and supporting deviations and change controls related to computerized systems. This position work closely with the Digital Plant (IT/Automation) subject matter experts and other key stakeholders, such as Manufacturing Science and Technology (MS&T), Quality Engineering (QE), and Manufacturing Operations.

Major Duties & Job Responsibilities:

• Gain a thorough understanding of computer systems deployed at Devens CTF.

• Act as CSV Subject Matter Expert (SME) for computerized system related changes and associated IT/Automation projects – advising operations on CSV matters and defending their work before regulatory agencies.

• Day-to-day oversight of the CSV program, ensuring standardization and consistency of qualification testing documents and associated testing deviations, providing escalations to CSV Lead as appropriate.

• Drive and own the validation lifecycle documentation for newly implemented computerized systems

• Assist in development of appropriate validation methodologies in collaboration with Operations Management and Quality Assurance for novel projects.

• Review and approve validation lifecycle documents as part of CSV activities, supporting the risk assessments, specifications, pre- and post-approval of qualification testing.

• Participates in regulatory audits as Digital Plant secondary representative and assists in generating responses to audit observations.

• Provides IT quality support to Devens CTF Digital Plant team through quality review and approval of investigations or change controls, deviation ownership of computerized system events, and CSV activities.

• Interact with Infinity (Quality Management System) to enter deviations and associated actions, investigations and associated root cause analysis, supporting data, corrective action/preventative action (CAPA) and effectiveness reviews as needed.

• Interact with ServiceNow to review and approve digital changes.

• Provide quality support of Digital Plant programs and system maintenance activities.

• Responsible for routine completion of quality events, quality actions, risk assessments, and other compliance documentation associated to computerized systems

• Ability to support on-call deviations on a rotational basis.

• Perform project audits as the needs arise.

• Ensure that Digital Plant standard operating procedures (SOPs) and procedural methodologies employed to maintain the validated state are regularly reviewed and updated as it pertains to CSV responsibilities as needed

Knowledge & Skills:

• Knowledge of science generally attained through studies resulting in a B.S., in science, engineering, biochemistry or related discipline, or its equivalent is required.

• A minimum of six (6) years of relevant experience in a regulated environment with at least four (4) years focused on quality assurance, validation, or compliance for computerized systems.

• Knowledge of CSV principles, GAMP 5 concepts, FDA 21 CFR Part 11, and data integrity is required.

• Knowledge of various Manufacturing IT systems such as: Process Automation System (DeltaV), Manufacturing Execution Systems (Syncade), Data Historians (OSI PI), Enterprise Resource Planning (SAP), Laboratory Information Management System (Celabs) is preferred.

• Knowledge of various GxP supporting systems, such as Quality Management System (Infinity) and Document Management Systems (CelDox) is desirable.

• Knowledge of paperless validation systems, such as ValGenesis is preferred, not required.

• Project Management experience around manufacturing automation systems is desired.

• Experience working in a team-based environment with a diverse group of people.

• Experience managing multiple large projects and staffing resources accordingly.

• High quality assurance mindset with Quality Assurance experience in the computer system and pharmaceutical computerized systems field and understanding of quality risk management principles.

• Understanding of SOPs, cGMPs and other compliance requirements including guidelines within a regulatory environment (FDA, EU).

• Proficiency in project management, oral communication, and technical writing skills are required.

Decision Making:

• Exercises sound judgment in making decisions and recommendations. Routinely makes decisions and takes or influences action on typical and atypical cases.

• Works on assignments that are extremely complex in nature where independent action and a high degree of initiative are required in resolving problems and developing recommendations. Erroneous decisions or failure to achieve results will have significant financial implications, compliance implications or cause significant delays in schedules.

• Coordinates with higher level IT CSV personnel on decisions and applies appropriate notification to management as appropriate.

Supervision Received:

• Incumbent typically manages a complete function or process, either through staff, the coordination of a team, or individual efforts. Receives assignments in the form of objectives and establishes goals to meet objectives. Work is measured based on meeting established objectives and schedules.

• Receives assignments which require the application of a defined process to complete the assignment. As such, specific assignments are allocated based upon the recipient’s demonstrated capabilities with the degree of supervisory attention determined accordingly.

Contacts:

• Work both independently and in a team environment at all levels of the organization, in particular Digital Plant, MS&T, Validation, Quality and Manufacturing Operations.

Working Conditions:

• Work within Site Facilities, which requires one to give a high attention to detail and on occasion to properly use Personal Protective Equipment (PPE). May work on cross-site initiatives to drive policy.

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.

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.

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 a supportive culture, promoting global participation 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 an 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.

Supporting People with Disabilities

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.

Candidate Rights

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/

Data Protection

We will never request payments, financial information, or social security numbers during our application or recruitment process. Learn more about protecting yourself at https://careers.bms.com/fraud-protection.

Any data processed in connection with role applications will be treated in accordance with applicable data privacy policies and regulations.

If you believe that the job posting is missing information required by local law or incorrect in any way, please contact BMS at TAEnablement@bms.com. Please provide the Job Title and Requisition number so we can review. Communications related to your application should not be sent to this email and you will not receive a response. Inquiries related to the status of your application should be directed to Chat with Ripley.

R1596107 : Senior Engineer, IT Computer System Validation (CSV)