Manager, Quality Engineering and Validation

3 weeks ago

Bothell, United States Bristol-Myers Squibb Full time
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.

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: careers.bms.com/working-with-us.

At Bristol Myers Squibb we are reimagining the future of cell therapy. With our bold ambition, backed by a best-in-the-industry team and long-term commitment, we are leading the way to unlock the full promise of cell therapy as we strive to put more patients on the path to a cure. If you are ready to challenge yourself, accelerate your career, and give new hope to patients, there's no better place than here at BMS with our Cell Therapy team.

The Quality Engineering and Validation (QEV) team at BMS is responsible for providing Quality Assurance oversight of regulated equipment, facility, utility, site automation (MES, DeltaV, InfoBatch, PI System, etc.), maintenance, process validation and engineering documents, test protocols, CAPAs, deviations, change control records, and additional site-based technical documentation and activities. The Manager, QEV is an individual contributor role, and provides cross-functional support within the department for quality oversight of qualification and validation activities, primarily around computerized systems and automated equipment at the BMS "Jump" site in Bothell, WA.

Shift Available:
  • Monday - Friday, Hybrid Day Shift
Responsibilities:
  • Review and approve records in a Quality Assurance capacity in support of cGMP operations, including but not limited to validation assessments, plans, test protocols and reports, standard operating procedures, and related Quality Management System records (CAPAs, deviations, change controls, etc.).
  • Mentor and be a resource for 1-3 junior coworkers or contractors.
  • Participate in Risk Assessments and complete Risk Analysis deliverables, as appropriate.
  • Ensure adherence to internal procedures and industry / regulatory expectations related to GxP controls and system releases before, during and after production operations (i.e. routine operations - calibration / maintenance, shutdowns, construction projects, etc.).
  • Collaborate with stakeholders within and outside of the Bothell manufacturing facility and communicate status / monitor progress and issue status reports.
  • Act as Quality Engineering Subject Matter Expert for responsible areas / projects during regulatory inspections as needed.
  • Drive continuous improvement and increase efficiency and productivity.
Knowledge & Skills:
  • Knowledge of cGMP regulations, automation / computerized systems standards, FDA, EMA and PMDA guidelines applicable to biologics and cell therapy.
  • Detail oriented, with strong GMP quality and engineering experience.
  • Highly capable individual contributor with demonstrated ability to work independently.
  • Excellent communication, trouble shooting, and problem-solving skills.
  • Direct experience with computerized systems / equipment (analytical and production), facility, and/or utility qualifications, technology transfer and/or process validation in a biopharmaceutical environment.
  • Experience in use of computer systems related to validation, calibration, maintenance, change control, and deviations strongly preferred. (e.g., ValGenesis, ALM, CMMS, D/L/QMS, etc).
  • Must have strong cGMP, and quality knowledge.
  • Experience in the application / use of risk management tools in a regulated industry.
Basic Requirements:
  • Bachelor of Science degree in life science or engineering discipline, or equivalent industry experience (a combination of industry-specific education and work experience may be used to substitute this degree requirement).
  • A minimum of 8 years relevant GMP operations experience.
  • A minimum of 5 years of equipment qualification or computer systems validation experience.
  • A minimum of 5 years of direct experience with providing GxP Quality guidance and support, or Validation project leadership in a commercial, regulated biopharmaceutical organization (cell / gene therapy industry experience strongly preferred).
  • A minimum of 3 years of principals for CSV.
Preferred Requirements:
  • Process Validation oversite.
  • Method transfer experience.
  • QC Analytical experience.
  • Automation validation experience.


The starting compensation for this job is a range from $97,000 to $121,000, plus incentive cash and stock opportunities (based on eligibility).

The starting pay rate takes into account characteristics of the job, such as required skills and where the job is performed.
Final, individual compensation will be decided based on demonstrated experience.

Eligibility for specific benefits listed on our careers site may vary based on the job and location. For more on benefits, please visit our BMS Careers Site.

Benefit offerings are subject to the terms and conditions of the applicable plans then in effect and may include the following: Medical,
pharmacy, dental and vision care. Wellbeing support such as the BMS Living Life Better program and employee assistance programs (EAP).
Financial well-being resources and a 401(K). Financial protection benefits such as short- and long-term disability, life insurance, supplemental health insurance, business travel protection and survivor support. Work-life programs include paid national holidays and optional holidays, Global Shutdown days between Christmas and New Year's holiday, up to 120 hours of paid vacation, up to two (2) paid days to volunteer, sick time off, and summer hours flexibility. Parental, caregiver, bereavement, and military leave. Family care services such as adoption and surrogacy reimbursement, fertility/infertility benefits, support for traveling mothers, and child, elder and pet care resources. Other perks like tuition reimbursement and a recognition program.

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 adastaffingsupport@bms.com. Visit careers.bms.com/eeo-accessibility 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.

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

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