Manager, Quality Engineering & Validation; QEV

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.

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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,…