Senior Compliance Engineer, Equipment Commissioning

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

Benefits offered by this job

Comprehensive benefits

Flexible Time Off

11 paid holidays

Paid vacation

Job summary

Principal Compliance Engineer, ECQ at Bristol Myers Squibb in Summit, NJ leads QA/compliance for equipment commissioning and qualification. You guide gap analyses, drive projects, and ensure ongoing validation across facility, lab, and business functions.

Role requires deep cGMP/GXP knowledge, regulatory familiarity (FDA/EMA/USP/EP/JP), and strong communication. You will manage teams, create impactful documentation, and work in a fast-paced, highly collaborative setting.

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.

Responsibilities

• Ensure all equipment and technologies comply 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.
• Participate in revisions of departmental procedures to maintain compliance.
• Prepare for internal and external audits.

Skills

GxP knowledge

21 CFR 11

Documentation practices

Regulatory guidelines

Multi-tasking

Communication skills

Team leadership

Project management

Presentation skills

Interpersonal skills

Problem solving

Education

BS in Engineering or Science-related discipline

Tools

Microsoft Office Suite

Database systems

Job description

Principal Compliance Engineer, ECQ at Bristol Myers Squibb in Summit, NJ leads QA/compliance for equipment commissioning and qualification. You guide gap analyses, drive projects, and ensure ongoing validation across facility, lab, and business functions.

Role requires deep cGMP/GXP knowledge, regulatory familiarity (FDA/EMA/USP/EP/JP), and strong communication. You will manage teams, create impactful documentation, and work in a fast-paced, highly collaborative setting.