Validation Engineer

Bristol Myers Squibb

Bothell, WA, United States
Base: $83,220 - $100,847; bonus/equity: + incentiv...
On-site
Gmp asset management and validation
Regulatory requirements and industry standards
Validation protocols, risk assessments, and qualification plans
Bristol Myers Squibb is seeking a Validation Engineer for their Bothell, WA facility. The role involves ensuring compliance with GMP regulations and requires hands-on experience in validation processes within a regulated manufacturing environment

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 and act as a validation Subject Matter Expert (SME) providing support to multi-function teams.
  • The company offers a wide variety of competitive benefits, services and programs that provide employees with the resources to pursue their goals, both at work and in their personal lives.

Matching Summary

Match Score: 85

Bristol Myers Squibb is seeking a Validation Engineer for their Bothell, WA facility. The role involves ensuring compliance with GMP regulations and requires hands-on experience in validation processes within a regulated manufacturing environment.

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

Nice-to-have

  • foster a culture of compliance, quality, and continuous improvement
  • learn from others and consistently steps up proactively
  • demonstrate BMS values
  • experience with electronic document management systems
  • cell therapy industry experience

Key Requirements

  • Bachelor’s Degree in life sciences/engineering/STEM or equivalent
  • 2+ years of commissioning, qualification, and validation (CQV) experience
  • Experience with equipment/utility/facility qualifications
  • Experience with investigations, deviations and CAPA management
  • Excellent project and program management, communication skills, and technical writing skills

Work Rights

Not specified

Tailored Resume

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