Manager, Quality Engineering & Validation (QEV)

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Challenging. Meaningful. Life-changing. Those arent 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. Youll 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: Summary:

The Quality Engineering and Validation (QEV) team at BMS is responsible for providing Quality Assurance oversight of validation programs for regulated equipment facility utility IT/automation and related maintenance and engineering records as well as some process validation deviation / CAPA / change control (Quality Management System) records and additional site-based GMP technical documentation and activities. The Manager QEV is an individual contributor role and provides cross-functional support for Quality oversight of qualification and validation activities primarily around commissioning & qualification of facilities / utilities and equipment including automated filling machines and processes and cleaning / sterilization cycle development (with VHP). This role is located at the BMS Cell Therapy manufacturing site in Bothell WA. Hybrid position (50% on-site in Bothell WA USA).

Duties / Responsibilities:

• Provide Quality Assurance oversight for qualification and validation activities related to equipment facilities utilities and automated systems.

• Review and approve validation protocols reports and related documentation to ensure compliance with GMP and regulatory requirements.

• Support commissioning and qualification of new and existing manufacturing systems including automated filling machines and VHP sterilization processes.

• Collaborate with Engineering Manufacturing and Quality teams to ensure timely execution of validation deliverables.

• Participate in investigations.

• Ensure adherence to site and global validation standards and procedures.

• Provide guidance on risk assessments and validation strategies for new projects and process improvements.

• Maintain accurate and complete GMP documentation for validation activities.

• Participate in investigations and support regulatory inspections / internal audits by providing validation-related documentation and expertise.

• Drive continuous improvements to increase efficiency and productivity.

• Other related duties as assigned.

Qualifications:

• Specific Knowledge Skills Abilities:

  • Strong knowledge of commissioning qualification and validation principles for facilities utilities and equipment.

  • Experience with automated filling systems aseptic processes and sterilization methods (including VHP).

  • Familiarity with Quality Management Systems (deviation CAPA change control) and regulatory requirements (FDA EMA ICH).

  • Ability to interpret and apply GMP regulations and industry standards (e.g. ISPE ASTM USP).

  • Excellent communication documentation and organizational skills.

  • Proven ability to work independently and collaboratively in a fast-paced environment.

• Education/Experience/ Licenses/Certifications:

  • Bachelors degree in Engineering Life Sciences or a related technical discipline. Equivalent industry experience (a combination of industry-specific education and work experience) may be used to substitute this requirement.

  • 8 years relevant biopharmaceutical industry experience.

  • 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).

  • Direct experience with automated filling systems / equipment facility and/or utility qualifications technology transfer and/or process validation in a biopharmaceutical environment strongly preferred.

If you come across a role that intrigues you but doesnt 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.

The starting compensation range(s) for this role are listed above for a full-time employee (FTE) basis. Additional incentive cash and stock opportunities (based on eligibility) may be available. The starting pay rate takes into account characteristics of the job such as required skills where the job is performed the employees work schedule job-related knowledge and experience. 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 offerings are subject to the terms and conditions of the applicable plans in effect at the time and may require enrollment. Our benefits include:

• Health Coverage: Medical pharmacy dental and vision care.

• Wellbeing Support: Programs such as BMS Well-Being Account BMS Living Life Better and Employee Assistance Programs (EAP).

• Financial Well-being and Protection: 401(k) plan short- and long-term disability life insurance accident insurance supplemental health insurance business travel protection personal liability protection identity theft benefit legal support and survivor support.

Work-life benefits include:

Paid Time Off

• US Exempt Employees: flexible time off (unlimited with manager approval 11 paid national holidays (not applicable to employees in Phoenix AZ Puerto Rico or Rayzebio employees)

• Phoenix AZ Puerto Rico and Rayzebio Exempt Non-Exempt Hourly Employees: 160 hours annual paid vacation for new hires with manager approval 11 national holidays and 3 optional holidays

Based on eligibility* additional time off for employees may include unlimited paid sick time up to 2 paid volunteer days per year summer hours flexibility leaves of absence for medical personal parental caregiver bereavement and military needs and an annual Global Shutdown between Christmas and New Years Day.

All global employees full and part-time who are actively employed at and paid directly by BMS at the end of the calendar year are eligible to take advantage of the Global Shutdown.

*Eligibility Disclosure: The summer hours program is for United States (U.S.) office-based employees due to the unique nature of their work. Summer hours are generally not available for field sales and manufacturing operations and may also be limited for the capability centers. Employees in remote-by-design or lab-based roles may be eligible for summer hours depending on the nature of their work and should discuss eligibility with their manager. Employees covered under a collective bargaining agreement should consult that document to determine if they are eligible. Contractors leased workers and other service providers are not eligible to participate in the program.

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 a supportive culture promoting global participation 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 an 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.

Supporting People with Disabilities

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.

Candidate Rights

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

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