Manager, Quality Engineering & Validation; QEV

Manager, Quality Engineering & Validation (QEV)

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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).

• 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.

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

Bothell - WA - US $108,410 - $131,366

• 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.
• Paid Time Off
  • US Exempt Employees: flexible time off (unlimited, with manager…