Senior Specialist, Validation

4 days ago


Bothell, Washington, United States Bristol-Myers Squibb Full time

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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