Bristol Myers Squibb

Senior Manager, Computer Systems Validation

Summit West - NJ - US Full time

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.

  • Senior Manager, Computer Systems Validation (CSV) – Cell Therapy

    Location: Summit, NJ
    Department: Equipment Commissioning and Qualification Organization

    Position Summary

    The Senior Manager, Computer Systems Validation (CSV), Equipment Commissioning & Qualification supports design, development, delivery, validation, maintenance, and support of GMP computerized systems at multi-use sites. This individual interacts with internal team members, peer-level customers, and external service providers, supporting multiple projects and ongoing activities to ensure regulatory compliance. The Senior Manager supervises contract and/or full-time staff to facilitate departmental deliverables and directly supports CTDO Summit.

    Key Responsibilities

    Management:

    • Lead a team of up to 9 people.
    • Interview and hire internal/external personnel as needed.
    • Provide direction to team members.
    • Set individual and team contributions.
    • Ensure appropriate training for all team members.
    • Promote safety and adherence to site EHS procedures and guidelines.
    • Ensure full compliance with BMS policies and procedures.
    • Staff team appropriately and ensure technical competence across equipment technologies and groups.

    Commissioning, Qualification, and Validation Activities:

    • Manage and allocate resources for CSV activities on laboratory and manufacturing computerized systems.
    • Provide technical input for validation deviations, technical assessments for change requests, and identify qualification/validation requirements for GMP compliance.
    • Assist in design, analysis, execution, and approval of IQ, OQ, PQ, and UAT protocols and reports.
    • Perform technical reviews of validation deliverables.
    • Develop technical support manuals and address system troubleshooting pre and post system release.
    • Build and manage a team capable of learning and configuring new applications, system architectures, and instrumentation.
    • Identify regulatory gaps and provide technical/procedural mitigations.
    • Address technical and compliance challenges across the System Validation Lifecycle; research, test, and generate solutions.
    • Perform 21 CFR Part 11 and system risk assessments.
    • Define needs, benefits, and technical strategy within the project life-cycle and processes.
    • Ensure CSV resources are knowledgeable of latest industry regulations and initiatives.
    • Lead Continuous Improvement efforts for the program.
    • Promote and provide excellent customer service and support.
    • Provide technical support and guidance on equipment and computer systems qualification and validation issues.
    • Foster a positive team environment within the Equipment Commissioning & Qualification department and with site customers.

    Regulatory:

    • Ensure computerized standalone systems are implemented and maintained in compliance with regulatory requirements.
    • Serve as subject matter expert during internal audits or external regulatory inspections.

    Reporting:

    • Reports to Equipment Commissioning and Qualification Organization.

    Qualifications

    • BS in Computer Engineering, Computer Science, or related discipline preferred.
    • Minimum 10 years’ experience in a GMP environment.
    • Minimum 7 years’ experience in pharmaceutical computer systems validation in a GMP environment.
    • Minimum 5 years’ experience managing personnel and/or projects.
    • Experience interacting with regulatory agents and auditors in compliance audit environments, including direct face-to-face interactions.
    • Thorough knowledge of cGMP in the pharmaceutical industry.
    • Advanced computer skills with demonstrated knowledge of validating computer systems used in the pharmaceutical industry.
    • Strong problem-solving, verbal, and written communication skills.
    • Ability to work independently.
    • Strong interpersonal skills, team orientation, and professional maturity.

    Apply now to join a team dedicated to innovation and excellence in cell therapy!

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.

Compensation Overview:

Summit West - NJ - US: $125,740 - $152,368

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.

R1598863 : Senior Manager, Computer Systems Validation