Manager, Principal Compliance Engineer

Bristol Myers Squibb

Summit, New Jersey, United States
Base: $106,630 - $129,214; bonus/equity: + incenti...
50% onsite
Advanced knowledge of cgmp and gxp regulations
Experience with fda 21cfr part 11 compliance
Strong background in computer systems validation
The Principal Compliance Engineer will lead a team responsible for ensuring equipment and technologies remain in a validated state through periodic reviews

Job Summary

  • The Principal Compliance Engineer will lead a team responsible for ensuring equipment and technologies remain in a validated state through periodic reviews.
  • This role requires advanced knowledge of regulatory guidelines including FDA, EMA, USP, EP, and JP to ensure global compliance.
  • Bristol Myers Squibb offers competitive benefits including health coverage, financial protection, and flexible time off options.

Matching Summary

The Principal Compliance Engineer will lead a team responsible for ensuring equipment and technologies remain in a validated state through periodic reviews.

Salary

Base: $106,630 - $129,214; Bonus/Equity: Additional incentive cash and stock opportunities available; Benefits: Health, dental, vision, 401(k), paid time off

Skills & Requirements

Must-have

  • Advanced knowledge of cGMP and GXP regulations
  • Experience with FDA 21CFR Part 11 compliance
  • Strong background in computer systems validation
  • Ability to perform gap analyses on equipment
  • Proven experience leading compliance projects

Nice-to-have

  • Excellent written and verbal communication skills
  • Experience working with diverse workforce
  • High proficiency in Microsoft Office Suite
  • Ability to quickly learn new enterprise software
  • Strong presentation development and delivery skills

Key Requirements

  • BS in Engineering or Science-related discipline
  • Minimum 5 years' experience in FDA-regulated industry
  • 2 years' experience in quality assurance preferred

Work Rights

Not specified

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