Senior Engineer, It Computer System Validation (csv)

Bristor Myers Squibb

Devens, MA, United States
Base: $99,480 - $120,551; bonus/equity: not specif...
On-site
Computerized system validation (csv)
Regulatory agencies defense
Validation lifecycle documentation
Bristol Myers Squibb is seeking a Senior Engineer for IT Computer System Validation at their Devens, MA facility. The role focuses on managing CSV activities and providing quality support for computerized systems, requiring extensive experience in a regulated environment

Job Summary

  • The Senior Engineer, IT Computer System Validation role will provide support to the Digital Plant team through managing computerized system validation (CSV) activities and supporting deviations and change controls.
  • This position will act as CSV Subject Matter Expert (SME) for computerized system related changes and associated IT/Automation projects, advising operations on CSV matters and defending their work before regulatory agencies.
  • Bristol Myers Squibb offers a wide variety of competitive benefits, services and programs that provide employees with resources to pursue their goals, both at work and in their personal lives.

Matching Summary

Match Score: 85

Bristol Myers Squibb is seeking a Senior Engineer for IT Computer System Validation at their Devens, MA facility. The role focuses on managing CSV activities and providing quality support for computerized systems, requiring extensive experience in a regulated environment.

Salary

Base: $99,480 - $120,551; Bonus/Equity: Not specified; Benefits: Health Coverage, Wellbeing Support, Financial Well-being and Protection, Work-life benefits

Skills & Requirements

Must-have

  • Computerized system validation (CSV)
  • Regulatory agencies defense
  • Validation lifecycle documentation
  • GxP supporting systems
  • Risk assessment principles

Nice-to-have

  • Collaboration with diverse teams
  • Project management experience
  • Paperless validation systems knowledge

Key Requirements

  • 6 years relevant experience
  • 4 years focused on QA, validation, or compliance for computerized systems
  • Knowledge of CSV principles, GAMP 5, FDA 21 CFR Part 11, data integrity
  • BS in science, engineering, biochemistry or related discipline

Work Rights

Not specified

Tailored Resume

Cover Letter