Bristol Myers Squibb · 10 hours ago
Manager, Quality Engineering
Devens - MA - US
Full-time
Onsite
Mid, Senior Level
$105K/yr - $128K/yr
6+ years expBristol Myers Squibb is a company dedicated to transforming patients' lives through science. The Manager, Quality Engineering will provide Quality oversight of qualification and validation activities for the Devens Cell Therapy Facility, ensuring compliance with local and global standards.
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 effectively communicate with team members
Demonstrate strong interpersonal skills, regarding teamwork collaboration, verbal, and written communication
Strong technical and problem-solving skills and the ability to work independently
Knowledge of regulatory requirements, primarily cGMP, GxP, including 21CFR part 11, and good documentation practices
Must be action-oriented, customer-focused, and skilled in decision-making, building relationships, problem solving, conflict management, planning and organizing, coaching others, and analytical thinking
Understanding of quality management systems
Knowledge of science generally attained through studies resulting in a bachelor's degree in a scientific or engineering discipline or its equivalent
A minimum of 6 years' experience in an environment governed by cGMPs, including at least 3 years of validation-related experience, (e.g., equipment qualification, computer system validation, analytical equipment / method validation, or process validation)
Preferred
Knowledge of applicable business systems including SAP, LIMS, Maximo and Veeva Vault is desirable
Knowledge of manufacturing executions systems such as Syncade and distributive control systems such as DeltaV is desirable
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
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.
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
2026-01-09
2026-01-08
Company data provided by crunchbase