Senior Compliance Engineer, ECQ – Equipment Validation

Bristol Myers Squibb EU Policy; South Hadley Falls (MA); On-site; USD 107,000 - 129,000; Full time

Benefits offered by this job

Health Coverage

Wellbeing Support

401(k) plan

Job summary

Principal Compliance Engineer, ECQ at Bristol Myers Squibb is responsible for leading equipment commissioning and qualification activities to ensure ongoing GMP/compliance across Summit West, NJ operations. The role involves coordinating with internal teams, vendors, and auditors to maintain validated state and drive process improvements.

The candidate should have a BS in engineering or science, 5+ years in FDA-regulated industries, and strong communication skills to support cross-functional

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 computer skills, including knowledge of calibration management and environmental monitoring systems.
• Strong verbal and written communication skills; able to work independently.
• Must possess strong interpersonal and communication skills, be a team player, and demonstrate professional maturity, initiative, and accountability.

Responsibilities

• Ensure Equipment Compliance with local, global, and regulatory policies, procedures, and guidelines.
• 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.
• Participate in revisions of departmental procedures to maintain compliance.
• Ensure departmental procedures and policies are aligned with current local, global, and regulatory requirements.
• Support or lead HPR on-demand board meetings and investigations/deviations.
• Identify, scope, lead, and support projects of varying complexity to maintain equipment and departmental compliance.
• Participate in and prepare for both internal and external audits.

Job description

Principal Compliance Engineer, ECQ at Bristol Myers Squibb is responsible for leading equipment commissioning and qualification activities to ensure ongoing GMP/compliance across Summit West, NJ operations. The role involves coordinating with internal teams, vendors, and auditors to maintain validated state and drive process improvements.

The candidate should have a BS in engineering or science, 5+ years in FDA-regulated industries, and strong communication skills to support cross-functional