Manager, Sr. Engineer Computer Systems 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 rich in diversity. 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

Purpose and Scope of Position:

The Manager, Sr. Engineer, CSV works cross-functionally to lead and execute validation activities for GxP electronic systems and applications used in cell therapy manufacturing. This role is primarily an individual contributor but will routinely lead supporting contract resources on project work. The Manager, Sr. Engineer, CSV is supported by a local CSV team and will partner with site Business Owners, Technical Owners and Quality as well as the global BMS IT / CSV network to create, manage, and improve computerized systems validation deliverables for electronic systems (including data management), applications and associated controls to maintain data integrity supporting ALCOA+ principles throughout the validation lifecycle. The Manager, Sr. Engineer, CSV will have responsibility to ensure the validation of electronic systems and applications are done in accordance with the relevant BMS procedures and global health authority regulations, and works to improve processes for greater control and efficiencies over time.

Duties and Responsibilities:

• Author, review and approve applicable CSV documentation
• Assist Business Owners and Technical Owners to develop requirements and specifications for computerized systems used in GxP operations
• Assist Business Owners and Technical Owners during system assessments, test executions, documentation of test failures and ensure testing aligns with internal procedures and global health authority regulations
• Partner with IT Operations, Business Owners, Technical Owners and Quality on continuous improvement of data management practices and documentation relating to the application of ALCOA+ principles of GxP data integrity throughout the data lifecycle, including data mapping and criticality assessments
• Support regulatory inspections as a subject matter expert (SME) as needed
• Conduct impact assessments for changes related to validated computerized systems
• Support Quality Systems records investigations and analyses
• Perform periodic reviews of applicable procedures and system validations
• Manage supporting contract resources as needed
• Assist with site integration and enterprise harmonization activities as needed

Education:

Bachelor's degree in a life sciences, engineering or technology discipline preferred, or equivalent combination of education, training, and experience.

Experience:

• 3+ years of direct experience with validation activities in a health authority regulated environment, strong knowledge of GAMP, risk-based approaches to validation, including Computer Software Assurance (CSA) principles
• Strong knowledge of health authority regulations, current industry practices, and experience with application of guidelines and regulations related to control of computerized systems, electronic records and electronic signatures
• 2+ years of direct experience with Quality Systems records (Deviations, CAPAs, Change Requests, SOPs) and related activities
• Demonstrated understanding of management of electronic records / signatures in alignment with the ALCOA+ principles of data integrity
• Strong knowledge of global health authority regulations, current industry practices, and experience with application of guidelines and regulations related to control of computerized systems, electronic records and electronic signatures
• Familiar with development of CSV documentation (Validation Plans, Requirements, Design / Configuration Specifications, Test Scripts [IQ / OQ / PQ/UAT], Summary Reports, Trace Matrices, SOPs)
• Familiar with database constructs and data storage systems / hosting technologies

#LI-Hybrid

The starting compensation for this job is a range from $92,000 - $115,000, plus incentive cash and stock opportunities (based on eligibility).

The starting pay rate takes into account characteristics of the job, such as required skills and the where the job is performed. Final individual compensation will be decided based on demonstrated experience.

For more on benefits, please visit our https://careers.bms.com/working-with-us.

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
Physical presence at the BMS worksite or physical presence in the field is a necessary job function of this role, which the Company deems critical to collaboration, innovation, productivity, employee well-being and engagement, and it enhances the Company culture.

COVID-19 Information
To protect the safety of our workforce, customers, patients and communities, the policy of the Company requires all employees and workers in the U.S. and Puerto Rico to be fully vaccinated against COVID-19, unless they have received an exception based on an approved request for a medical or religious reasonable accommodation. Therefore, all BMS applicants seeking a role located in the U.S. and Puerto Rico must confirm that they have already received or are willing to receive the full COVID-19 vaccination by their start date as a qualification of the role and condition of employment. This requirement is subject to state and local law restrictions and may not be applicable to employees working in certain jurisdictions such as Montana. This requirement is also subject to discussions with collective bargaining representatives in the U.S.

BMS is dedicated to ensuring that people with disabilities can perform complex functions through a transparent recruitment process, reasonable workplace adjustments and ongoing support in their roles. Applicants can request an accommodation prior to accepting a job offer. If you require reasonable accommodation 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 will consider for employment qualified applicants with arrest and conviction records, pursuant to applicable laws in your area.

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