Senior Engineer, It Computer System Validation (csv)

Bristol Myers Squibb

Devens, MA, US
Base: $99,480 - $120,551; bonus/equity: + incentiv...
50% onsite
Six years regulated environment experience
Four years computerized system validation
Gamp 5 and fda 21 cfr part 11 knowledge
This role supports the Digital Plant team at the Devens Cell Therapy Facility by managing computerized system validation activities and major projects

Job Summary

  • This role supports the Digital Plant team at the Devens Cell Therapy Facility by managing computerized system validation activities and major projects.
  • The position requires acting as a Subject Matter Expert to advise operations on CSV matters and defend work before regulatory agencies like the FDA.
  • Bristol Myers Squibb offers competitive benefits including flexible time off, health coverage, and a supportive culture focused on transforming patients' lives.

Matching Summary

This role supports the Digital Plant team at the Devens Cell Therapy Facility by managing computerized system validation activities and major projects.

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 SAP systems
  • Knowledge of ValGenesis paperless tools
  • Team-based diverse collaboration skills
  • Strong technical writing proficiency

Key Requirements

  • Bachelor's degree in science or engineering
  • Minimum six years relevant experience
  • At least four years in QA/validation/compliance
  • Understanding of cGMPs and SOPs
  • Proficiency in project management and communication

Work Rights

Not specified

Tailored Resume

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