Principal Compliance Engineer, ECQ - Equipment Validation Lead

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

Benefits offered by this job

Comprehensive benefits

Flexible Time Off

11 paid company holidays

Job summary

Bristol Myers Squibb in Summit, NJ is seeking a Principal Compliance Engineer, ECQ to lead equipment commissioning & qualification activities and guide a team of personnel in maintaining validated state of equipment.

Responsibilities include performing gap analyses, leading projects, ensuring compliance with FDA, EMA, USP, and regulatory guidelines, and preparing for internal and external audits while collaborating with cross-functional teams.

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 calibration management and environmental monitoring systems.

Responsibilities

• Ensure all equipment and technologies at Bristol Myers Squibb comply 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.

Skills

cGMP/GXP

GAMP knowledge

SDLC regulations

Documentation practices

Effective communication

Education

BS in Engineering or Science

Tools

MS Office

Database systems

Job description

Bristol Myers Squibb in Summit, NJ is seeking a Principal Compliance Engineer, ECQ to lead equipment commissioning & qualification activities and guide a team of personnel in maintaining validated state of equipment.

Responsibilities include performing gap analyses, leading projects, ensuring compliance with FDA, EMA, USP, and regulatory guidelines, and preparing for internal and external audits while collaborating with cross-functional teams.