Job Description

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.

Position Summary

The Manager, Quality Engineering at the Cell Therapy Facility (CTF) in Devens, MA will be responsible for providing Quality oversight of qualification and validation activities and change control for the startup and continuing operations of the Devens Cell Therapy Facility, including commissioning, qualification, and validation (CQV), computer systems validation (CSV) and process validation per established local and global standards.

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.

    Qualifications

  • 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 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

    • Education/Experience/ Licenses/Certifications:

  • 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)

    • Compensation Overview:

    Devens - MA - US: $105,450 - $127,782

    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.

    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 . Visit 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.

    Data Protection

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

    R1597924 : Manager, Quality Engineering

    Apply for this Position

    Ready to join ? Click the button below to submit your application.

    Submit Application