Principal Compliance Engineer – Equipment Qualification

Bristol-Myers Squibb; United States; On-site; USD 107,000 - 129,000; Full time

Job summary

Bristol Myers Squibb is seeking a Principal Compliance Engineer, ECQ, to lead equipment commissioning and qualification efforts at Summit, NJ. You will manage a team (contract or full-time) performing periodic reviews to keep equipment in a validated state, drive gap analyses, and lead regulatory-compliance projects.

The role requires strong knowledge of cGMP, FDA regulations, and QA processes, with an emphasis on documentation, training, and cross-functional collaboration across manufacturing

Qualifications

• BS in Engineering or Science-related discipline is required.
• Minimum of 5 years' experience in an FDA-regulated industry.
• 2 years' experience in a quality assurance-related discipline preferred.
• In-depth knowledge of regulatory guidelines (FDA, EMA, USP, EP, JP).
• Excellent verbal and written communication skills; able to work independently.
• Strong interpersonal and communication skills; team player and proactive.

Responsibilities

• Ensure Equipment Compliance with local, global, and regulatory policies.
• Review and implement revisions to USP, EP, JP, FDA, and regulatory guidelines.
• Perform gap analyses on existing equipment and technologies.
• Review new equipment and technologies to ensure compliance.
• Review and revise departmental procedures to maintain compliance.
• Support or lead HPR on-demand board meetings and investigations/deviations.
• Identify, scope, lead, and support projects to maintain equipment and departmental compliance.
• Participate in internal and external audits.

Skills

GXP, cGMP

21 CFR Part 11

Regulatory knowledge

Communication skills

Multi-tasking

Project leadership

MS Office

Enterprise apps knowledge

Organizational skills

Education

BS in Engineering or Science-related discipline

5+ years in FDA-regulated industry

QA discipline experience preferred

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

Tools

Calibration management software

Environmental monitoring systems

Job description

Bristol Myers Squibb is seeking a Principal Compliance Engineer, ECQ, to lead equipment commissioning and qualification efforts at Summit, NJ. You will manage a team (contract or full-time) performing periodic reviews to keep equipment in a validated state, drive gap analyses, and lead regulatory-compliance projects.

The role requires strong knowledge of cGMP, FDA regulations, and QA processes, with an emphasis on documentation, training, and cross-functional collaboration across manufacturing