Senior Engineer, It Computer System Validation (csv)

Bristol Myers Squibb

Devens, MA, US
Base: $99,480 - $120,551; bonus/equity: + incentiv...
Hybrid (50% onsite)
Six years regulated environment experience
Four years computerized system validation
Gamp 5 and fda 21 cfr part 11 knowledge
Bristol Myers Squibb is seeking a Senior Engineer for IT Computer System Validation in their Devens, MA facility. The role focuses on managing computerized system validation activities and collaborating with various departments to support regulatory compliance in a dynamic environment

Job Summary

  • This role supports the Digital Plant team at the Devens Cell Therapy Facility by managing CSV activities and major projects.
  • The position requires acting as a Subject Matter Expert to defend work before regulatory agencies and participate in audits.
  • Bristol Myers Squibb offers competitive benefits including health coverage, financial protection, and flexible time off policies.

Matching Summary

Match Score: 85

Bristol Myers Squibb is seeking a Senior Engineer for IT Computer System Validation in their Devens, MA facility. The role focuses on managing computerized system validation activities and collaborating with various departments to support regulatory compliance in a dynamic environment.

Salary

Base: $99,480 - $120,551; Bonus/Equity: Additional incentive cash and stock opportunities available; Benefits: Medical, dental, vision, 401(k), paid time off

Skills & Requirements

Must-have

  • Six years regulated environment experience
  • Four years computerized system validation
  • GAMP 5 and FDA 21 CFR Part 11 knowledge
  • Data integrity principles application
  • Validation lifecycle documentation ownership

Nice-to-have

  • Project management for automation systems
  • Experience with DeltaV and Syncade systems
  • Knowledge of ValGenesis paperless validation
  • Team-based collaboration skills
  • Risk assessment expertise

Key Requirements

  • Bachelor's degree in science or engineering
  • Minimum six years relevant experience
  • At least four years focused on QA/validation
  • Understanding of cGMPs and FDA guidelines

Work Rights

Not specified

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