Senior Compliance Engineer Lead, Equipment QC (ECQ)

Bristol-Myers Squibb; Summit (NJ); Hybrid; USD 107,000 - 129,000; Full time

Benefits offered by this job

Health Coverage

Wellbeing Programs

401(k) plan

Paid Time Off

Job summary

Bristol Myers Squibb Summit, NJ seeks a Manager, Principal Compliance Engineer to lead ECQ for equipment validation, review regulatory guidelines, and drive compliance across labs and facilities. You’ll manage internal and external teams to ensure state-of-the-art equipment validation and quality systems adherence.

The role requires extensive cGMP knowledge, regulatory experience, and strong communication and project leadership skills in a fast-paced, highly regulated environment.

Qualifications

• Advanced knowledge of cGMP, GXP, GAMP and SDLC regulations.
• Familiar with 21 CFR Part 11 and computer systems validation practices.
• Experience with QA in FDA-regulated environments and GMP laboratories.

Responsibilities

• Ensure equipment and technologies meet regulatory policies and guidelines.
• Review and revise procedures to stay aligned with global requirements.
• Lead or support compliance projects and regulatory audits.

Skills

cGMP knowledge

GXP

GAMP

SDLC

21CFR Part 11

Computer systems validation

Documentation practices

pharmaceutical manufacturing

laboratory systems

attention to detail

communication skills

interpersonal skills

multi-tasking

MS Office

database systems

learn new software

presentations

Education

BS in Engineering or Science-related discipline

5+ years experience in FDA-regulated industry

2 years experience in QA-related discipline preferred

Regulatory guidelines knowledge (FDA, EMA, USP, EP, JP)

Tools

Calibration management

Environmental monitoring systems

MS Office Suite

Database systems

Job description

Bristol Myers Squibb Summit, NJ seeks a Manager, Principal Compliance Engineer to lead ECQ for equipment validation, review regulatory guidelines, and drive compliance across labs and facilities. You’ll manage internal and external teams to ensure state-of-the-art equipment validation and quality systems adherence.

The role requires extensive cGMP knowledge, regulatory experience, and strong communication and project leadership skills in a fast-paced, highly regulated environment.