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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 .

Position Summary

Manufacturing Sciences & Technology (MSAT) Automation Compliance Sr. Specialist will be responsible for ensuring quality and promoting efficiency of Manufacturing Automation Systems at BMS. The individual will work to maximize the utility of the system, including streamlining deviation and CAPA processes, as well as document administration activities. The individual will also be called upon to support software release activities, investigations, and providing coordination around complex projects. The individual will support projects at BMS's current multi-product clinical facility in Bothell, WA with potential to support future manufacturing capacity at additional locations.

Key Responsibilities

Lead the compliance program for the MSAT Cell Therapy Engineering Services (CTES) Automation including the following:

• Investigate deviations, performing advanced root cause analysis where required

• Develop mitigation plans, corrective actions, and preventative actions for deviations

• Lead analysis and investigation of deviation trends for automation applications (Syncade, DeltaV, InfoBatch, etc.)

• Ensure written reports contain the technical merit per regulatory expectations

• Own or support the Software Development Lifecycle process for automation and recipe configuration

• Author / contribute content, review and approve applicable Quality Systems records, including Deviations, CAPAs, Change Requests, SOPs, and others as needed

• Partner with Quality, and Business / Technical Owners on continuous improvement efforts to reduce or eliminate adverse trends related to Quality Events impactful to MSAT CTES

• Lead weekly compliance meetings to discuss open investigations, trends, and best practices

• Track and drive to closure quality system records including deviation, CAPA, change controls

• Identify, track, and report on key metrics such as Right First Time

• Represent MSAT Automation on deviation, CAPA review boards and/or PBL meetings

• Identify and implement opportunities for continuous improvement, operational efficiency, and system reliability

• Execute User Access Audits

• Regulatory Inspection/ Internal Audit support

• Attend real-time triage events with an emphasis on quality

Provide backup and support to the MES Business System Owner including:

• Support maintenance of portfolio of active and backlog projects impacting the MES system

• Track and communicate project status throughout the project cycle to customers/stakeholders

• Collaborate with site and corporate functions (Quality, Manufacturing, MSAT, Supply Chain, IT)

• Lead functional and cross functional design and development meetings

• Represent the MES system and provide support during regulatory inspections

Qualifications & Experience

Basic Qualifications:

• Experience with deviation investigation, change control ownership, and corrective action development

• Experience with cGMP/GMP, ICH guidelines, data integrity, computer system validation, and working within a Quality organization

• Excellent written and verbal skills, ability to clearly organize written requirements is essential

• Experience with deviation investigation, change control ownership, and corrective action development

• Strong communication and collaboration skills

• Experience working within electronic document management systems/quality management systems for regulated industries

Preferred Qualifications:

• Experience with Emerson Syncade MES, Emerson DeltaV, InfoBatch or other computerized / automation systems

• Capable of exercising sound judgment while adapting to rapidly changing priorities, challenging situations, and deadlines

• Demonstrated ability to work in a matrixed structure; focused strongly on customer service and communication

• Highly motivated individual with the ability to work independently as well as on a cross-functional site and corporate teams

• Technical understanding of cell culture processing. Familiarity with cell therapy a plus

• Excellent written and presentations skills

Education/Experience/ Licenses/Certifications:

B.A./B.S. in computer science, life sciences, engineering, or equivalent combination of education and work experience with a minimum of 5 years in the pharmaceutical/ biopharmaceutical industry

The starting compensation for this job is a range from $82,000 - $102,000, plus incentive cash and stock opportunities (based on eligibility).

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

For more on benefits, please visit our BMS Careers si te.

Eligibility for specific benefits listed in our careers site may vary based on the job and location.

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.

BMSCART

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

BMS has a diverse 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.

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/ (https://careers.bms.com/eeo-accessibility) eeo-accessibility to access our complete Equal Employment Opportunity statement.

BMS cares about your well-being and the well-being of our staff, customers, patients, and communities. As a result, the Company strongly recommends that all employees be fully vaccinated for Covid-19 and keep up to date with Covid-19 boosters.

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/

Any data processed in connection with role applications will be treated in accordance with applicable data privacy policies and regulations.

Company: Bristol-Myers Squibb

Req Number: R1589791

Updated: 2025-03-10 04:04:20.529 UTC

Location: Bothell-WA

Bristol Myers Squibb is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, age, disability, protected veteran status, pregnancy, citizenship, marital status, gender expression, genetic information, political affiliation, or any other characteristic protected by law.