Manager, Principal Compliance Engineer

About this role

Working with Us Challenging. Meaningful. Life-changing. Those aren’t words that are usually associated with a job. But working at Bristol Myers Squibb is anything but usual. Here, uniquely interesting work happens every day, in every department. From optimizing a production line to the latest breakthroughs in cell therapy, this is work that transforms the lives of patients, and the careers of those who do it. You’ll get the chance to grow and thrive through opportunities uncommon in scale and scope, alongside high-achieving teams. Take your career farther than you thought possible.

Bristol Myers Squibb recognizes the importance of balance and flexibility in our work environment. We offer a wide variety of competitive benefits, services and programs that provide our employees with the resources to pursue their goals, both at work and in their personal lives. Read more: careers.bms.com/working-with-us .

Position Title: Principal Compliance Engineer, ECQ Location: Summit West, NJ

Purpose and Scope of Position 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.

This job description provides a general overview of the responsibilities and requirements for the Principal Compliance Engineer, ECQ position. Additional duties may be assigned as needed.

If you come across a role that intrigues you but doesn’t perfectly line up with your resume, we encourage you to apply anyway. You could be one step away from work that will transform your life and career.

Compensation Overview:

Summit West - NJ - US: $106,630 - $129,214
 The starting compensation range(s) for this role are listed above for a full-time employee (FTE) basis. Additional incentive cash and stock opportunities (based on eligibility) may be available. The starting pay rate takes into account characteristics of the job, such as required skills, where the job is performed, the employee’s work schedule, job-related knowledge, and experience. Final, individual compensation will be decided based on demonstrated experience. 

Eligibility for specific benefits listed on our careers site may vary based on the job and location. For more on benefits, please visit https://careers.bms.com/life-at-bms/.   Benefit offerings are subject to the te

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