Automation Engineer I
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. Key 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.
- 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.
- 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.
- 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.
- 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.
- 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
Princeton - NJ - US: $100,100 - $121,293 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 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.
- 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
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 [email protected] . 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: 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 . 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 [email protected] . 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. R1600097 : Automation Engineer I
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