Manager Computer System Validation

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. About the Role This position will drive computer system validation activities for the Summit site Manufacturing Execution Systems (MES) supporting the Summit, NJ Cell Therapy manufacturing site. This role is ideal for someone with a strong IT/Computer Science foundation and 5 years or more of hands-on experience in the pharma/biotech industry. You’ll partner with other cross-functional teams such as QA, Business, and IT teams to ensure compliant and efficient deployment of MES & Recipes solutions and support. Key Responsibilities * Lead end-to-end validation activities including test preparation, authoring of IQ/System/UAT scripts, Dry Run, test data setup, environment readiness, test execution facilitation, and post-execution review. * Coordinate recipe configuration, master data setup, and validation in Syncade MES. * 3+ years of experience with Emerson Syncade MES, including knowledge of recipes, equipment and material management, and MES implementations in the pharmaceutical area. * Author, Review and Approve validation documentation lifecycle: Validation & Test Plan, requirement, Test Scripts, Assessment documents, and Summary Reports. * Validate electronic batch records (EBR), MES recipes, interfaces, and integration with systems such as SAP, Oracle, LIMS, CMMS, GPS, and EDMS. * Ensure all activities comply with 21 CFR Part 11, GAMP 5, and internal SOPs. * Strong project management skills (organization, collaboration, multi-tasking and communication), high degree of attention to detail, and the ability to perform well in a team-based environment are required. * Provide assistance as needed to support Health Authority inspections and internal audits. * Assist with investigations, triage deviations, and ensure CAPAs are addressed and implemented for MES. * Assist with program metrics by developing applicable tools and trackers, generating and analyzing quality system data for trending, performance deficiencies, and conformance to KPIs. Develops appropriate action plans as needed to remediate or continually improve on quality system performance. * Collaborate with Business Owners, QA, and IT to align on requirements and ensure CSV deliverables are compliant and audit ready. * Ensure validation practices meet GAMP 5, CSA, 21 CFR Part 11, and ALCOA+ data integrity principles. Required Competencies * Proven ability to manage competing priorities with a flexible workstyle and consistently deliver efficient, compliant results in fast-paced, cross-functional environments. * Experienced in cross-functional communication, with the ability to interpret and convey business and IT needs for Validation; comfortable interacting with QA, business, and technical teams. * Understanding of MES Syncade & Recipes testing phases (IQ, System Testing, Recipe UAT). * Familiarity with cGMP, GAMP, SDLC, 21 CFR Part 11, and Good Documentation Practices (GDP). * Demonstrated ability to independently lead system validation efforts across multiple stakeholder groups. Basic Qualifications * Bachelor’s degree in Computer Science, Information Systems, or a related engineering discipline. * Minimum 5 years of experience or more in pharma/biotech, with focus on IT -Validation and Quality Assurance & Compliance * Experience with MES platforms (Syncade preferred) and electronic batch records (EBR). * Familiar with tools such as ALM, ServiceNow, SQL databases, and document management systems. * Knowledge of shop floor operations, process automation, and manufacturing environments are preferable• * 5+ years of Computer System Validation (CSV) experience in regulated pharmaceutical and biotech environments, with strong knowledge of GAMP 5, 21 CFR Part 11, and Computer Software Assurance (CSA) principles. * 3+ years of hands-on MES experience with Emerson Syncade, including recipe validation, EBR testing, and interface verification with systems such as SAP, LIMS, and Oracle. * Experience with project management, demonstrating the ability to prioritize urgent tasks, manage competing deadlines, and adapt effectively within dynamic, cross-functional teams. * Experience with ALM, ServiceNow, SQL databases, and document management systems (e.g., Veeva, BMSDocs), supporting testing, issue tracking, and controlled documentation. The starting compensation for this job is a range from $90,440- $109,600, 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 where the job is performed. 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 then in effect and may include the following: Medical, pharmacy, dental and vision care. Wellbeing support such as the BMS Living Life Better program and employee assistance programs (EAP). Financial well-being resources and a 401(K). Financial protection benefits such as short- and long-term disability, life insurance, supplemental health insurance, business travel protection and survivor support. Work-life programs include paid national holidays and optional holidays, Global Shutdown Days between Christmas and New Year’s holiday, up to 120 hours of paid vacation, up to two (2) paid days to volunteer, sick time off, and summer hours flexibility. Parental, caregiver, bereavement, and military leave. Family care services such as adoption and surrogacy reimbursement, fertility/infertility benefits, support for traveling mothers, and child, elder and pet care resources. Other perks like tuition reimbursement and a recognition program. 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: $90,440 - $109,592 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. 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. 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. For employees on leave and contractors or contingent workers, refer to related articles. 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.