Senior Validation Specialist

3 weeks ago


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

We are seeking a highly skilled Validation Specialist to join our team at Bristol-Myers Squibb. As a key member of our validation team, you will be responsible for ensuring the quality and integrity of our cell therapy products.

Key Responsibilities
  • Develop and execute validation plans for cGMP critical equipment and systems
  • Establish validation protocols, risk assessments, and qualification plans to support GMP operations
  • Act as a validation Subject Matter Expert (SME) providing support to multi-function teams
  • Collaborate with cross-functional teams to manage workload, prioritize tasks, and meet schedules
  • Regularly review, prioritize, and respond to customer equipment qualification and support requests
Requirements
  • Bachelor's Degree in life sciences, engineering, or a related field
  • 3+ years of commissioning, qualification, and validation (CQV) experience in a regulated industry
  • Knowledge of cGMP, GDP, GXP, GAMP5 regulations, and data integrity requirements
  • Experience with equipment/utility/facility qualifications and general CQV practices
What We Offer

Bristol-Myers Squibb offers a competitive salary, incentive cash, and stock opportunities, as well as a comprehensive benefits package, including medical, pharmacy, dental, and vision care, wellbeing support, and financial well-being resources.



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