Manager, Principal Compliance Engineer

Principal Compliance Engineer, ECQ

The Principal Compliance Engineer, Equipment Commissioning & Qualification (ECQ), supports the successful operation of facility, laboratory, and business functions at Summit, NJ. This role involves interaction with internal team members, peer-level customers, and external service providers. The Principal Compliance Engineer will lead a team of contract or full-time personnel responsible for performing periodic reviews of equipment, policies, and procedures to ensure they remain in a validated state. Responsibilities include performing gap analyses, and leading small and large-scale projects to achieve departmental objectives.

Required Competencies: Knowledge, Skills, and Abilities

• Advanced knowledge of cGMP, GXP, GAMP, SDLC regulations, including 21CFR part 11, computer systems validation requirements, and good documentation practices.
• Advanced understanding of pharmaceutical, manufacturing, and laboratory systems and equipment.
• Strong attention to detail.
• Exceptional written and verbal communication skills.
• Excellent interpersonal skills; experience working with a inclusive workforce.
• Proven multi-tasking and organizational skills; ability to manage multiple concurrent assignments in a high-paced environment.
• Strong presentation development and delivery skills.
• Highly proficient in Microsoft Office Suite (Word, Excel, PowerPoint, Outlook) and extensive background in database systems.
• Ability to quickly learn new software, such as corporate intranet and enterprise business applications.
• Ability to organize and present information clearly.

Education and Experience

• 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.

Duties and Responsibilities

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

Working Conditions

• Physical/Mental Demands
• Occasional stooping, bending, stretching, pushing, pulling, reaching, and/or lifting up to 25 lbs.
• Ability to sit, stand, walk, and move within workspace for extended periods.
• Ability to perform repetitive tasks, including hand-to-finger manipulations, grasping, pushing, and pulling.
• Environmental Conditions
• Primarily office-based, but will require entry into laboratory or GMP process areas with proper gowning, lab coats, PPE (safety glasses, shoes).
• Ability to work safely and effectively both independently and with others.