Bristol Myers Squibb · 1 day ago
Senior Specialist
Devens, MA
Full-time
Onsite
Mid, Senior Level
$85K/yr - $102K/yr
4+ years expBristol Myers Squibb is a company dedicated to transforming patients' lives through science. The Senior Specialist, Quality Engineering is responsible for quality oversight of engineering and validation lifecycle activities, ensuring compliance and supporting continuous improvement initiatives within the team.
BiotechnologyHealth CareMedicalPharmaceuticalPrecision Medicine
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
Qualification
Required
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
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
Preferred
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
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.
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
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.
Company
Bristol Myers Squibb
At Bristol Myers Squibb, we work every day to transform patients’ lives through science.
10001+ employees
H1B Sponsorship
Bristol Myers Squibb has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (247)
2024 (278)
2023 (231)
2022 (180)
2021 (181)
2020 (169)
Funding
Current Stage
Public CompanyTotal Funding
$29.32BKey Investors
Venrock
2025-11-05Post Ipo Debt· $5.74B
2024-02-14Post Ipo Debt· $13B
2023-10-30Post Ipo Debt· $4.5B
Leadership Team
Charles Bancroft
CFO
Cristian Massacesi
Executive Vice President, Chief Medical Officer and Head of Development
Recent News
2026-01-08
2026-01-07
2026-01-07
Company data provided by crunchbase