Manager, Quality Engineering

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:

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.

• Review and approve commissioning and qualification
  
  Think 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.

This role is stationed in Devens, MA and reports to Middle Associate Director of Quality Engineering for the Devens Cell Therapy Facility.

• 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 21
  
  CFR 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 Delta
  
  V is desirable

• Knowledge of science generally attained through studies resulting in a bachelor’s degree in a scientific or engineering discipline or its equivalent

• A coraz minimum of 6 years’ experience in an environment governed by cGMPs, including at least 3 years of validation-related…