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Job Details

Bristol Myers Squibb

Manager, Quality Engineering - Change Control

Engineering and Architecture

Architectural Engineering


Devens, Massachusetts, United States

At Bristol Myers Squibb, we are inspired by a single vision – transforming patients’ lives through science. In oncology, hematology, immunology and cardiovascular disease – and one of the most diverse and promising pipelines in the industry – each of our passionate colleagues contribute to innovations that drive meaningful change. We bring a human touch to every treatment we pioneer. Join us and make a difference.


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.

  • This particular role will be for the Change Control Business Process Owner role, although other responsibilities listed here may also apply

REQUIRED COMPETENCIES: Knowledge, Skills, and Abilities

  • 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


  • Ensures that all regulatory and cGMPs compliance items related to validation are satisfied and ensures Validation Master Plan (VMP) adherence.
  • Demonstrates appropriate examples for compliance behaviors and attitudes, thereby shaping the culture.
  • Meets and exceeds all safety expectations and adheres to all BMS behaviors.
  • Provides guidance and mentorship to less experienced staff and onboards consulting staff, as necessary.
  • Identifies, advocates for, and support opportunities for continuous improvement.
  • Responds to inquiries from audits and inspections from world health authorities.
  • Verifies compliance with applicable BMS Policies, Guidelines and Directives and ensures consistency with other site procedures and/or specifications.
  • Supports the administration and maintenance of the site change control system, assuring consistency with establishing standards for local and global change control systems, and leads the local change review board, as necessary.
  • Additionally, the Manager, Quality Engineering may contribute to or supervise a small team of quality engineers overseeing activities in one or more of the following disciplines:

CSV Role: Provides oversight on following

  • Computer System Lifecycle Documents, risk assessments and strategies
  • User Acceptance Testing / Installation Qualification / Operational Qualification protocols/ deviations/ reports
  • Support Tech Transfer initiatives
  • Responsible for maintenance of the site technical review board and IT change management process, assuring consistency with establishing standards for local and global change control systems

Process/Equipment Roles: Provides oversight on following

  • Process Validation Master Plans, risk assessments and strategies
  • Process performance qualification (PPQ) protocols/deviations/reports
  • Tech Transfer, scale-up and supporting studies
  • Commissioning and Qualification Lifecycle Documents, risk assessments and strategies
  • Installation Qualification/Operational Qualification protocols/deviations/reports, as applicable
  • Calibration and maintenance activities, as applicable

Change Control Business Process Owner Role:

  • Owns and leads the local change review board
  • Serves as site representative for Global Change Review Board and ensures site impact is captured on applicable multi-site changes
  • Ensures change control program compliance with local and global governance
  • Responsible for change control metrics and system health
  • Identifies and drives continuous improvement for the change control program
  • Works closely with site and global process owners to align and drive best practices
  • Regularly presents to site leadership
  • Provide general guidance and change expertise to site members


  • 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)


  • Must be able to gown for ISO 8 and ISO 7 rooms (medical scrubs, safety shoes, safety glasses, gloves, coveralls, booties, etc.).

This job description is intended to describe the general nature and level of work being performed by the person assigned to this position. The primary duties and responsibilities are intended to describe those functions that are essential to the performance of this job.

This job description does not state or imply that the above are the only duties and responsibilities assigned to this position. There are other duties and responsibilities that are considered incidental or secondary to the overall purpose of this job. Employees holding this position will be required to perform any other job-related duties as requested by management


Around the world, we are passionate about making an impact on the lives of patients with serious diseases. Empowered to apply our individual talents and diverse perspectives in an inclusive culture, our shared values of passion, innovation, urgency, accountability, inclusion and integrity bring out the highest potential of each of our colleagues.

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.

Physical presence at the BMS worksite or physical presence in the field is an essential job function of this role which the Company deems critical to collaboration, innovation, productivity, employee well-being and engagement, and enhances the Company culture.

To protect the safety of our workforce, customers, patients and communities, the policy of the Company requires all employees and workers in the U.S. and Puerto Rico to be fully vaccinated against COVID-19, unless they have received an exception based on an approved request for a medical or religious reasonable accommodation. Therefore, all BMS applicants seeking a role located in the U.S. and Puerto Rico must confirm that they have already received or are willing to receive the full COVID-19 vaccination by their start date as a qualification of the role and condition of employment. This requirement is subject to state and local law restrictions and may not be applicable to employees working in certain jurisdictions such as Montana. This requirement is also subject to discussions with collective bargaining representatives in the U.S.

Our company is committed to ensuring that people with disabilities can excel through a transparent recruitment process, reasonable workplace adjustments and ongoing support in their roles. Applicants can request an approval of accommodation prior to accepting a job offer. If you require reasonable accommodation in completing this application or if you are applying to a role based in the U.S. or Puerto Rico and you believe that you are unable to receive a COVID-19 vaccine due to a medical condition or sincerely held religious belief, during or any part of the recruitment process, please direct your inquiries to Visit to access our complete Equal Employment Opportunity statement.

BMS will consider for employment qualified applicants with arrest and conviction records, pursuant to applicable laws in your area.

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