Lead Engineer

About the Role

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. Bristol Myers Squibb recognizes the importance of balance and flexibility in our work environment, offering a wide variety of competitive benefits, services, and programs that provide employees with resources to pursue their goals, both at work and in their personal lives.

Responsibilities

• Commissioning and Qualification Activities:
  • Maintain qualified equipment systems in compliance with policies, guidelines, and procedures.
  • Develop qualification protocols and associated reports while adhering to a change management process.
  • Execute equipment qualifications and validation protocols.
  • Supervise vendors for qualification functions.
  • Support development of equipment operational procedures.
  • Support equipment validation activities.
  • Develop validation/qualification deliverables such as Validation Plans, Requirements Specifications, Design Specifications, Traceability Matrices, and Summary Reports.
  • Support Change Management process.
• Project Work Support:
  • Manage equipment implementation projects including scheduling, site prep, installation, qualification, and turnover to business area.
  • Support internal customer groups in the operation, calibration, and preventive maintenance of equipment to meet business needs in accordance with required schedules or dates.
  • Lead and oversee contract project teams to ensure timely execution and adherence to all compliance and quality requirements.
  • Complete all qualification and validation documentation with accuracy, completeness, and compliance to BMS standards.
• Customer Service and Support:
  • Regularly review, prioritize, and promptly respond to customer equipment qualification and support requests.
  • Provide technical support and guidance on equipment qualification issues.
  • Interface with customers to ensure all expectations are being met.
  • Provide technical support and guidance on equipment, utilities, facilities, and computerized systems qualification and validation issues.
  • Maintain a positive relationship with all team members and site customers while promoting a positive team environment.
• Regulatory Responsibilities:
  • Ensure equipment, facilities, and programs are maintained in compliance.
  • May participate in deviation investigations as a Subject Matter Expert (SME).

Qualifications

• Knowledge of cGMP, GXP, GAMP, SDLC regulations, including 21 CFR Part 11, computer systems validation requirements, and good documentation practices.
• Knowledge of pharmaceutical, manufacturing, and laboratory systems.
• Understanding of investigations, deviations, and CAPA management in a regulated pharmaceutical industry.
• Strong written and verbal communication skills.
• Excellent interpersonal skills with experience dealing with a diverse workforce.
• Strong multitasking ability in conjunction with proven organizational skills.
• Ability to organize assigned tasks in a high-paced environment and concurrently monitor tasks/assignments with others that may impact timely completion.
• Ability to effectively manage multiple tasks and activities simultaneously.
• Highly proficient computer skills in Microsoft Office Suite – Word, Excel, PowerPoint, and Outlook, with extensive background in database systems.
• Innate ability to learn new software, such as corporate intranet and enterprise business tools.

Education and Experience

• BS in Engineering or Science-related discipline preferred but can be substituted with sufficient relevant experience.
• Minimum of 4 years of experience performing/supporting activities in a GMP environment.
• Minimum of 3 years of experience in equipment, facility, or utility qualification.
• Minimum of 2 years of project management experience in a GMP environment.

Pay

Summit West - NJ - US: $88,450 - $107,182. The starting compensation range(s) for this role are listed 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.

Benefits

Eligibility for specific benefits may vary based on the job and location. 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:
  • 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 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 Year's 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.