Manager, Principal Compliance Engineer

Bristol Myers Squibb • Summit, NJ

42d

About The Position

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.

Requirements

• 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 diverse 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.
• BS in Engineering or Science-related discipline is required.
• Minimum of 5 years’ experience in an FDA-regulated industry.
• 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.

Nice To Haves

• 2 years’ experience in a quality assurance-related discipline preferred.

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.

Benefits

• Health Coverage: Medical, pharmacy, dental, and vision care.
• Wellbeing Support: Programs such as BMS Well-Being Account, BMS Living Life Better, and Employee Assistance Programs (EAP).
• Financial Well-being and Protection: 401(k) plan, short- and long-term disability, life insurance, accident insurance, supplemental health insurance, business travel protection, personal liability protection, identity theft benefit, legal support, and survivor support.
• Work-life benefits include: Paid Time Off US Exempt Employees: flexible time off (unlimited, with manager approval, 11 paid national holidays (not applicable to employees in Phoenix, AZ, Puerto Rico or Rayzebio employees) Phoenix, AZ, Puerto Rico and Rayzebio Exempt, Non-Exempt, Hourly Employees: 160 hours annual paid vacation for new hires with manager approval, 11 national holidays, and 3 optional holidays Based on eligibility, additional time off for employees may include unlimited paid sick time, up to 2 paid volunteer days per year, summer hours flexibility, leaves of absence for medical, personal, parental, caregiver, bereavement, and military needs and an annual Global Shutdown between Christmas and New Years Day. All global employees full and part-time who are actively employed at and paid directly by BMS at the end of the calendar year are eligible to take advantage of the Global Shutdown.

What This Job Offers

• Job Type: Full-time
• Career Level: Principal