Senior Compliance Engineer, Equipment Qualification

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

Benefits offered by this job

Flexible Time Off

11 paid company holidays

Vacation time (160 hours)

Job summary

Bristol Myers Squibb in Summit West, NJ, seeks a Principal Compliance Engineer, ECQ to lead equipment commissioning and qualification programs, ensuring regulatory compliance across GMP environments. The role will supervise contract or full-time staff, perform gap analyses, and drive projects to compliance goals.

Strong documentation, communication, and cross-functional collaboration are essential as you support audits and continuous improvement in a fast-paced setting.

Qualifications

• BS in Engineering or Science-related discipline required.
• Minimum of 5 years’ experience in an FDA-regulated industry.
• 2 years’ experience in a quality assurance-related discipline preferred.

Responsibilities

• Ensure Equipment Compliance: ensure equipment and technologies comply with local, global, and regulatory guidelines.
• Review and revise USP, EP, JP, FDA, and regulatory guidelines for compliance.
• Perform gap analyses on existing equipment and technologies and review new equipment for compliance.
• Regulatory Responsibilities: participate in internal and external audits and prepare documentation.

Skills

cGMP/GXP

Documentation

Communication

Project management

Education

BS in Engineering or Science

Tools

Microsoft Office

Database systems

Job description

Bristol Myers Squibb in Summit West, NJ, seeks a Principal Compliance Engineer, ECQ to lead equipment commissioning and qualification programs, ensuring regulatory compliance across GMP environments. The role will supervise contract or full-time staff, perform gap analyses, and drive projects to compliance goals.

Strong documentation, communication, and cross-functional collaboration are essential as you support audits and continuous improvement in a fast-paced setting.