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Senior Specialist
- Bristol Myers Squibb (Devens, MA)
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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 .
Position Summary
The Quality Engineering team is responsible for quality oversight of engineering and validation lifecycle activities, including facility, equipment, and utility commissioning and qualification, computer systems validation, process validation, and technology transfer. The Senior Specialist, Quality Engineering is responsible for quality oversight.
Duties/Responsibilities
+ Review and approve commissioning and qualification lifecycle documentation associated with manufacturing site facilities/equipment/and utilities, including but not limited to system/component impact assessments, user requirements, configuration specifications, installation/operational qualification, performance qualification, requalification etc.
+ Review and approve computer systems validation lifecycle documentation associated with manufacturing site, standalone and site based computerized systems, including but not limited to system classification, user requirements, functional specifications, installation qualification, operational qualification / system testing, user acceptance testing, performance qualification, periodic review, etc.
+ May participate in and review/approve risk assessments, data integrity assessments, and technical reports supporting qualification
+ Perform routine quality review/approval activities associated with equipment/system onboarding and status
+ Identify improvement opportunities and support execution of team continuous improvement goals and projects
+ May review and approve or provide impact assessment for site change controls
+ Support internal and external inspections as required
+ Maintain compliance with assigned learning plan
+ Support integration of newer team members
+ Lead meetings and represent function at cross functional meetings. Share data/ knowledge within and across team. Build & maintain strong relationships with partner functions.
Reporting Relationship
+ This role is stationed in Devens, MA and reports to the Associate Director of Quality Engineering for the Devens Cell Therapy Facility.
Specific Knowledge, Skills, Abilities:
+ Ability to research, understand, interpret and apply internal policies and regulatory guidelines
+ Proficient computer skills with knowledge of several digital tools like MS Office, etc., and ability to learn and work with new software applications
+ Ability to interpret data & results, understand problems with multiple variables and critically assess and provide feedback on proposed solution and required documentation.
+ Ability to critically review reports, interpret results and assess and challenge technical conclusions consistent with Quality risk management principles
+ Excellent verbal and technical writing skills with ability to prepare written communications and present technical data to management with clarity and accuracy
+ Ability to work in a fast-paced team environment and changing priorities.
+ Detail oriented and task focused with ability to meet deadlines and prioritize work
+ Able to work across functional groups and teams to ensure requirements are met
+ Self motivated and contribute to a positive team environment
+ Confident in making decisions for minor issues and able to recognize Quality issues and solve problems.
+ Curious and ability to think critically to create innovative solutions
Education/Experience/ Licenses/Certifications:
+ Bachelor's degree in STEM field preferred. High school diploma/ Associates degree with equivalent combination of education and work experience may be considered.
+ 4+ years of experience in a regulated industry with 1+ year experience. Experience in FDA/EMA regulations in biopharmaceuticals or cell therapy manufacturing is preferred.
+ Demonstrated experience with electronic validation documentation systems.
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:
Devens - MA - US: $84,510 - $102,403
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.
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:** T he 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.
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 [email protected] . Visit careers.bms.com/ (https://careers.bms.com/eeo-accessibility) 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.
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.
R1597925 : Senior Specialist **Company:** Bristol-Myers Squibb
**Req Number:** R1597925
**Updated:** 2026-01-09 03:20:31.761 UTC
**Location:** Devens-MA
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.
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