Manager, Principal Compliance Engineer
Bristol Myers Squibb
August 13, 2026
Remote friendly (Summit, NJ)
United States
Corporate Functions
Principal Compliance Engineer, ECQ (Equipment Commissioning & Qualification) — Summit West, NJ
Purpose and Scope
- Support facility, laboratory, and business operations at Summit, NJ.
- Lead a team (contract or full-time) performing periodic reviews of equipment, policies, and procedures to keep them in a validated state.
- Perform gap analyses and lead small/large-scale projects to meet departmental objectives.
Responsibilities
- Ensure all equipment/technologies comply with local, global, and regulatory policies.
- Review and implement updates to USP/EP/JP/FDA and other regulatory guidelines.
- Perform gap analyses; review new equipment/technologies for compliance.
- Maintain ECQ departmental procedural compliance; align procedures/policies with current requirements.
- Support or lead Historical Performance Review (HPR) activities, investigations, and deviations.
- Identify, scope, and lead compliance projects of varying complexity.
- Participate in and prepare for internal and external audits.
Required/Preferred Qualifications & Skills
- BS in Engineering or Science-related field (required).
- 5+ years in an FDA-regulated industry (required); 2 years in a quality assurance discipline (preferred).
- In-depth regulatory knowledge (FDA, EMA, USP, EP, JP).
- Advanced cGMP/GXP/GAMP/SDLC knowledge, including 21 CFR Part 11; computer systems validation; good documentation.
- Strong attention to detail; exceptional written/verbal communication; interpersonal skills.
- Strong multitasking/organizational skills; presentation development/delivery.
- Proficient in Microsoft Office; extensive database systems background; ability to learn new software.
Compensation & Benefits (as stated)
- $106,630–$129,214; additional incentive opportunities may be available.
- Health coverage; wellbeing support; 401(k); disability/life insurance; PTO (flexible time off or annual vacation/holidays by location/role).
Working Conditions
- Office-based; may require entry into lab/GMP areas with proper gowning/PPE.
- Occasional lifting up to 25 lbs; ability to perform repetitive tasks.
Purpose and Scope
- Support facility, laboratory, and business operations at Summit, NJ.
- Lead a team (contract or full-time) performing periodic reviews of equipment, policies, and procedures to keep them in a validated state.
- Perform gap analyses and lead small/large-scale projects to meet departmental objectives.
Responsibilities
- Ensure all equipment/technologies comply with local, global, and regulatory policies.
- Review and implement updates to USP/EP/JP/FDA and other regulatory guidelines.
- Perform gap analyses; review new equipment/technologies for compliance.
- Maintain ECQ departmental procedural compliance; align procedures/policies with current requirements.
- Support or lead Historical Performance Review (HPR) activities, investigations, and deviations.
- Identify, scope, and lead compliance projects of varying complexity.
- Participate in and prepare for internal and external audits.
Required/Preferred Qualifications & Skills
- BS in Engineering or Science-related field (required).
- 5+ years in an FDA-regulated industry (required); 2 years in a quality assurance discipline (preferred).
- In-depth regulatory knowledge (FDA, EMA, USP, EP, JP).
- Advanced cGMP/GXP/GAMP/SDLC knowledge, including 21 CFR Part 11; computer systems validation; good documentation.
- Strong attention to detail; exceptional written/verbal communication; interpersonal skills.
- Strong multitasking/organizational skills; presentation development/delivery.
- Proficient in Microsoft Office; extensive database systems background; ability to learn new software.
Compensation & Benefits (as stated)
- $106,630–$129,214; additional incentive opportunities may be available.
- Health coverage; wellbeing support; 401(k); disability/life insurance; PTO (flexible time off or annual vacation/holidays by location/role).
Working Conditions
- Office-based; may require entry into lab/GMP areas with proper gowning/PPE.
- Occasional lifting up to 25 lbs; ability to perform repetitive tasks.