Manager, Principal Compliance Engineer

Celgene • Summit, NJ

3d • $106,630 - $129,214 • Onsite

About The 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 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.
• Participate in revisions of departmental procedures to maintain compliance.
• Ensure departmental procedures and policies are aligned with current local, global, and regulatory requirements.
• Support or lead HPR on-demand board meetings and investigations/deviations.
• Identify, scope, lead, and support projects of varying complexity to maintain equipment and departmental compliance.
• 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: Mid Level
• Number of Employees: 5,001-10,000 employees