Manager, Quality Engineering & Validation (QEV)

Bristol Myers Squibb • Bothell, WA

2d • $108,410 - $131,366 • Hybrid

About The Position

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).

Requirements

• 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.
• Bachelor’s 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).

Nice To Haves

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

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.

Benefits

• 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.

What This Job Offers

• Job Type: Full-time
• Career Level: Manager
• Number of Employees: 5,001-10,000 employees