Bristol Myers Squibb · 1 month ago
Manager, Quality Engineering & Validation (QEV)
Bothell - WA - US
Full-time
Hybrid
Senior Level, Lead/Staff
$108K/yr - $131K/yr
8+ years expBristol Myers Squibb is a biopharmaceutical company dedicated to transforming patients’ lives through science. The Manager, QEV will provide Quality Assurance oversight for validation programs and collaborate with cross-functional teams to ensure compliance with GMP and regulatory requirements.
BiotechnologyHealth CareMedicalPharmaceuticalPrecision Medicine
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
Qualification
Required
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
Preferred
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
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.
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)
Paid Time Off: 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
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.
Company
Bristol Myers Squibb
At Bristol Myers Squibb, we work every day to transform patients’ lives through science.
10001+ employees
H1B Sponsorship
Bristol Myers Squibb has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (247)
2024 (278)
2023 (231)
2022 (180)
2021 (181)
2020 (169)
Funding
Current Stage
Public CompanyTotal Funding
$29.32BKey Investors
Venrock
2025-11-05Post Ipo Debt· $5.74B
2024-02-14Post Ipo Debt· $13B
2023-10-30Post Ipo Debt· $4.5B
Leadership Team
Charles Bancroft
CFO
Cristian Massacesi
Executive Vice President, Chief Medical Officer and Head of Development
Recent News
Pharmaceutical Technology
2026-01-22
Company data provided by crunchbase