Principal Specialist, Quality Engineering

Bristol-Myers Squibb Company

Devens, MA

Working with Us
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Position Summary

The Quality Engineering team is responsible for quality oversight of engineering and validation lifecycle activities, including facility, equipment, and utility commissioning and qualification, computer systems validation, process validation, and technology transfer. The Principle Scientist, Quality Engineering will be responsible for providing Quality oversight to Commissioning, Qualification and Validation (CQV) activities and change control for the Devens Cell Therapy Facility.

Key Responsibilities

  • Provides document review and approval for facility, equipment, and utility commissioning and qualification, process validation, computer system and analytical validation documentation from both technical and compliance perspectives.

  • Ensures that all regulatory and cGMPs compliance items related to validation are satisfied and ensures Validation Master Plan (VMP) adherence.

  • Reviews and approves protocol discrepancies associated with the qualification and startup of the Devens Cell Therapy Facility and participates in resulting investigations and correction / corrective action planning.

  • 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.

  • Responsible for reviewing and approving change control and change actions within the determined time frames within the Quality Management System (QMS).

  • Provides quality oversight for calibration and maintenance activities.

  • Identifies unresolved issues/decisions related to validation documents and coordinates resolution with other departments.

  • 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.

  • Is recognized as a subject matter expert within Quality Engineering.

  • Act as SME and/or Quality reviewer/approver for complex risk assessments, data integrity assessments, and technical reports supporting the manufacturing process and supporting systems.

  • May perform routine quality review/approval activities associated with equipment/system onboarding and status.

  • Represent Quality on large capital projects or technology transfer initiatives and review/approve complex validation or master transfer plans.

  • Identifies improvement opportunities and drives execution of site/cross-functional continuous improvement goals and projects.

  • Support internal and external inspections as required. Participate in the preparation and execution corrective and preventative actions related to inspection findings.

  • Maintain compliance with assigned learning plan. Support development of training content.

  • Act as validation Subject Matter Expert in multiple validation disciplines and provide guidance/ coaching to less experienced staff and cross-functional partners with atypical events during qualification.

  • Lead meetings and represent function at cross functional and network meetings.

Qualifications & Experience

  • Bachelor's degree in STEM field preferred or its equivalence.

  • Over 8 years of experience in a regulated industry, preferably with at least 4 years of experience in validation related experience. (CSV preferred, analytical equipment, equipment qualification). Experience in FDA/EMA regulations in biopharmaceuticals or cell therapy manufacturing is preferred.

  • Demonstrated experience with electronic validation documentation systems.

  • 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

  • Experience in computerized tracking systems, such as Maximo, Valgenesis, INFINITY, Veeva Vault, preferred.

  • Advanced ability to interpret data & results, understand complex problems with multiple variables and critically assess and provide feedback on proposed solution and required documentation.

  • Advanced ability to critically review investigation reports, interpret results, and assess and challenge technical conclusions consistent with Quality risk management principles

  • Excellent verbal and technical writing skills with advanced ability to prepare written communications and present complex technical data to management with clarity and accuracy

  • Ability to work in a fast-paced team environment and lead team and cross-functional peers through changing priorities.

  • Ability to think strategically, meet deadlines and support work prioritization for team.

  • Able to independently work across and influence cross-functional groups and teams to ensure requirements are met.

  • Ability to motivate and foster a positive cross-functional team environment

  • Confident in making decisions, able to anticipate Quality issues and proactively solve critical and/or complex problems.

  • Curious, with the ability to think critically to create innovative solutions

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If you come across a role that intrigues you but doesn’t perfectly line up with your resume, we encourage you to apply anyway. You could be one step away from work that will transform your life and career.

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 an inclusive culture, promoting diversity 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 a diverse 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.

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.

BMS cares about your well-being and the well-being of our staff, customers, patients, and communities. As a result, the Company strongly recommends that all employees be fully vaccinated for Covid-19 and keep up to date with Covid-19 boosters.

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

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