Senior Engineer, It Computer System Validation (csv)

Bristol Myers Squibb

Devens, MA, United States
Base: $99,480 - $120,551; bonus/equity: not specif...
On-site
Computer system validation (csv)
Gxp supporting systems
Regulatory audits support
Bristol Myers Squibb is seeking a Senior Engineer for IT Computer System Validation (CSV) at their Devens, MA facility. The role involves managing computerized system validation activities, collaborating with various teams, and ensuring compliance with regulatory standards

Job Summary

  • The Senior Engineer, IT Computer System Validation role will provide support to the Digital Plant team at the Devens Cell Therapy Facility (CTF) through managing computerized system validation (CSV) activities and major projects.
  • This position will work closely with Digital Plant (IT/Automation) subject matter experts and other key stakeholders such as Manufacturing Science and Technology (MS&T), Quality Engineering (QE), and Manufacturing Operations.
  • Bristol Myers Squibb 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 Senior Engineer for IT Computer System Validation (CSV) at their Devens, MA facility. The role involves managing computerized system validation activities, collaborating with various teams, and ensuring compliance with regulatory standards.

Salary

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

Skills & Requirements

Must-have

  • Computer System Validation (CSV)
  • GxP supporting systems
  • Regulatory audits support
  • Quality risk management principles
  • Data integrity knowledge

Nice-to-have

  • Collaboration with diverse teams
  • Proactive problem resolution
  • Continuous improvement mindset

Key Requirements

  • Minimum of six (6) years of relevant experience
  • At least four (4) years focused on quality assurance, validation, or compliance for computerized systems
  • B.S. in science, engineering, biochemistry or related discipline
  • Knowledge of CSV principles, GAMP 5 concepts, FDA 21 CFR Part 11

Work Rights

Not specified

Tailored Resume

Cover Letter