Senior Specialist, Validation
4 days ago
Job Summary
The Senior Specialist, Validation role at Bristol-Myers Squibb is a critical position that requires a deep understanding of GMP, GDP, GXP, GAMP5 regulations, and data integrity requirements. As a Senior Specialist, you will be responsible for developing and executing validation plans for cGMP critical equipment and systems, ensuring compliance with applicable regulations and industry standards.
Key Responsibilities
- Develop and execute validation plans for cGMP critical equipment and systems
- Ensure compliance with applicable regulations and industry standards
- Partner with cross-functional teams to develop validation plans and ensure their execution and lifecycle management
- Act as a validation Subject Matter Expert (SME) providing support to multi-function teams
- Collaborate with peers within the cross-functional teams to manage workload, address priorities, meet schedules, maximize productivity, reduce costs, and increase efficiencies
Requirements
- Bachelor's Degree in life sciences/Engineering/STEM or equivalent
- 3+ years of commissioning, qualification, and validation (CQV) experience within technical and regulated industries
- Knowledge of cGMP, GDP, GXP, GAMP5 regulations, including 21CFR Part 11, computer systems validation requirements, EU GMP Annex 15, and data integrity requirements
What We Offer
Bristol-Myers Squibb offers a competitive salary range of $82,000 - $102,000, plus incentive cash and stock opportunities (based on eligibility). We also offer a wide variety of benefits, services, and programs that provide our employees with the resources to pursue their goals, both at work and in their personal lives.
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