Position Title:Principal Compliance Engineer, ECQ
Location:Summit West, NJ
Purpose and Scope of PositionThe 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 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.
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 ResponsibilitiesEnsure 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 ConditionsPhysical/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.
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 terms and conditions of the applicable plans in effect at the time and may require enrollment. Our benefits include:
- 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.
*Eligibility Disclosure: The summer hours program is for United States (U.S.) office-based employees due to the unique nature of their work. Summer hours are generally not available for field sales and manufacturing operations and may also be limited for the capability centers. Employees in remote-by-design or lab-based roles may be eligible for summer hours, depending on the nature of their work, and should discuss eligibility with their manager. Employees covered under a collective bargaining agreement should consult that document to determine if they are eligible. Contractors, leased workers and other service providers are not eligible to participate in the program.
