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Principal Specialist, Quality Engineering
4 months ago
**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 rich in diversity. Take your career farther than you thought possible.
**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.
- 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.
- 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
