Validation protocols, risk assessments, and qualification plans
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Bristol Myers Squibb is seeking a Validation Engineer for their Bothell, WA location to ensure compliance with regulatory requirements in a GMP manufacturing environment. The role demands hands-on experience in validation processes and collaboration with cross-functional teams to optimize operations.
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Job Summary
The Validation Engineer will play a critical role in ensuring compliance with all regulatory requirements and industry standards related to GMP asset management and validation in a regulated GMP manufacturing facility.
Establish validation protocols, risk assessments, and qualification plans to support GMP operations.
Stay abreast of all relevant GMP regulations, FDA guidelines, and international standards to ensure lab operations remain in full compliance.
Matching Summary
Match Score: 75
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Bristol Myers Squibb is seeking a Validation Engineer for their Bothell, WA location to ensure compliance with regulatory requirements in a GMP manufacturing environment. The role demands hands-on experience in validation processes and collaboration with cross-functional teams to optimize operations.
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Salary
Base: $83,220 - $100,847; Bonus/Equity: Additional incentive cash and stock opportunities may be available; Benefits: Health Coverage, Wellbeing Support, Financial Well-being and Protection, Paid Time Off
Skills & Requirements
Must-have
GMP asset management and validation
regulatory requirements and industry standards
validation protocols, risk assessments, and qualification plans
validation Subject Matter Expert (SME)
cGMP, GDP, GXP, GAMP5 regulations
validation lifecycle deliverables and documents
technical writing skills
Nice-to-have
foster a culture of compliance
drive innovation and improvement
cell therapy industry experience
Key Requirements
2+ years of commissioning, qualification, and validation (CQV) experience
Bachelor’s Degree in life sciences/engineering/STEM or equivalent
Experience with equipment/utility/facility qualifications
Experience with investigations, deviations and CAPA management
Knowledge and experience with electronic document management systems