Automation Engineer I

Bristol Myers Squibb • Princeton, NJ

2d

About The Position

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. Role Summary The Senior Engineer I, serves as the system owner and lifecycle steward for integrated automation systems supporting analytical methods in late-stage and commercial cell therapy programs. This role is responsible for maintaining systems in a validated and inspection-ready state across GMP and non-GMP laboratories. The position drives governance of technology transfers from Analytical Development/QC into ASAT, oversees system validation activities, and provides operational ownership, end-user support, and training. The role works cross-functionally with Analytical Development, Quality Control, Quality Assurance, IT, and manufacturing stakeholders to ensure automation systems meet business needs while maintaining compliance with cGMP and data integrity requirements.

Requirements

• BS or MS in engineering, computer science, or a related scientific discipline with 4+ years of experience in automation systems within a regulated environment.
• Demonstrated experience governing system validation activities (IQ, OQ, PQ) and lifecycle management in GMP environments.
• Experience supporting technology transfer of automated analytical methods from development to commercial operations.
• Working knowledge of integrated automation platforms such as Biosero, HighRes Biosolutions, Thermo Scientific, or equivalent systems.
• Experience in Automating Filling, capper decapper is plus.
• Strong understanding of 21 CFR Part 11, Annex 11, data integrity principles, and cGMP requirements.
• Experience authoring and maintaining validation documentation, SOPs, change controls, and deviation reports.
• Experience programming or troubleshooting liquid handling and automation workflows.
• Excellent problem-solving, verbal, written, and interpersonal communication skills.

Nice To Haves

• Experience deploying and maintaining automation systems in GxP environments.
• Experience managing and coordinating multiple automation vendors.
• Experience supporting regulatory inspections or audits related to automated systems.
• Familiarity with LIMS integration and laboratory informatics systems

Responsibilities

• System Ownership & Lifecycle Management Serve as the designated system owner for automated analytical platforms within ASAT, maintaining systems in a validated and inspection-ready state.
• Govern the full validation lifecycle (IQ, OQ, PQ), including protocol approval, execution oversight, periodic reviews, and revalidation activities.
• Maintain validation documentation including validation master plans, traceability matrices, SOPs, change controls, and deviation reports.
• Ensure compliance with 21 CFR Part 11, Annex 11, data integrity principles, and applicable cGMP regulations.
• Coordinate planned and unplanned system maintenance, upgrades, patches, and configuration changes through formal change control processes.
• Method & Technology Transfer Lead the technical transfer of automated analytical methods from Analytical Development into ASAT for commercial support.
• Collaborate with development teams to define transfer requirements and assess platform readiness for commercial operation.
• Oversee development and execution of technology transfer protocols, gap assessments, and comparability studies.
• Ensure transferred methods and systems meet commercial manufacturing and regulatory filing requirements.
• End-User Support & Training Provide day-to-day technical support to laboratory users operating automated systems.
• Develop and deliver training programs on system operation, troubleshooting, and compliance requirements.
• Create and maintain user guides, quick-reference materials, and training documentation.
• Serve as the primary escalation point for system issues, coordinating with vendors and IT.
• Cross-Functional Collaboration & Continuous Improvement Partner with QA, QC, IT, and manufacturing teams to support regulatory inspections, audits, and CAPA activities.
• Identify opportunities to optimize system performance, improve throughput, and reduce assay variability.
• Evaluate and recommend system upgrades and new automation technologies in collaboration with development teams and vendors.
• Foster User community of best practice and drive multisite harmonization.
• Should be able to work across cross functional team and across sites.

Benefits

• 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.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Number of Employees: 5,001-10,000 employees