Manager, Principal Compliance Engineer

Bristol Myers Squibb

Summit, NJ, United States
Base: $106,630 - $129,214; bonus/equity: + incenti...
50% onsite
Cgmp, gxp, gamp, sdlc regulations
21cfr part 11 compliance
Computer systems validation
This role involves interaction with internal team members, peer-level customers, and external service providers

Job Summary

  • This role involves interaction with internal team members, peer-level customers, and external service providers.
  • The Principal Compliance Engineer will lead a team of contract or full-time personnel responsible for performing periodic reviews of equipment, policies, and procedures to ensure they remain in a validated state.
  • Bristol Myers Squibb recognizes the importance of balance and flexibility in our work environment.

Matching Summary

This role involves interaction with internal team members, peer-level customers, and external service providers.

Salary

Base: $106,630 - $129,214; Bonus/Equity: Additional incentive cash and stock opportunities may be available; Benefits: Health Coverage, Wellbeing Support, Financial Well-being and Protection, Work-life benefits

Skills & Requirements

Must-have

  • cGMP, GXP, GAMP, SDLC regulations
  • 21CFR part 11 compliance
  • Computer systems validation
  • Good documentation practices
  • Pharmaceutical manufacturing and laboratory systems
  • Microsoft Office Suite proficiency

Nice-to-have

  • Experience with diverse workforce
  • Ability to learn new software quickly
  • Initiative and accountability
  • Team player mentality

Key Requirements

  • BS in Engineering or Science-related discipline
  • Minimum 5 years' experience in FDA-regulated industry
  • 2 years' experience in quality assurance-related discipline
  • In-depth knowledge of regulatory guidelines (FDA, EMA, USP, EP, JP)
  • Knowledge of calibration management and environmental monitoring systems

Work Rights

Not specified

Tailored Resume

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