ECQ Engineer Q3

Bristol Myers SquibbSummit, NJ
22d$36 - $43Onsite

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. The Equipment Engineer, Equipment Commissioning & Qualification (ECQ) Operations supports laboratory, clinical, and commercial manufacturing operations at Summit West. This role involves interaction with internal team members, customers, and external service providers. The ideal candidate works independently, solves common problems, and helps build collaborative relationships across teams. Responsibilities include leading small to medium projects, creating and revising work processes or procedures, writing deviations and investigations, and supporting change controls. The role requires the ability to support 12-hour day shift operations 3 to 4 days per week.

Requirements

  • Knowledge of cGMP, GXP, GAMP, SDLC regulations (including 21CFR part 11), computer systems validation requirements, and good documentation practices.
  • Advanced knowledge of pharmaceutical, manufacturing, and laboratory systems and equipment.
  • Strong written and verbal communication skills.
  • Excellent interpersonal skills; experience with diverse workforce, individual initiative, accountability, and professional maturity.
  • Strong multi-tasking and organizational skills; ability to manage multiple tasks and activities simultaneously in a fast-paced environment.
  • Highly proficient in Microsoft Office Suite (Word, Excel, PowerPoint, Outlook) and database systems.
  • Ability to quickly learn new software applications, such as corporate intranet and enterprise business systems.
  • Working knowledge of scheduling software and inventory management systems, mainly Blue Mountain RAM.
  • Ability to interact effectively with laboratory, QA, and Facilities groups.
  • Bachelor’s degree in Engineering or Science-related discipline preferred.
  • Minimum 2 years’ experience in FDA-regulated industry.
  • Excellent computer skills, including knowledge of calibration management and environmental monitoring systems.
  • Strong problem-solving skills, verbal and written communication skills, and ability to work independently.
  • Strong interpersonal and team skills; willingness to work in an environment requiring initiative and accountability.
  • 2 years of maintenance coordinating/planning experience, preferably in a laboratory environment.

Nice To Haves

  • Experience working directly with bench top manufacturing and laboratory equipment (cell counters, liquid handlers, Flow Cytometry, UPLC, HPLC, etc.) preferred.
  • Knowledge of cGMP in the pharmaceutical industry.
  • Experience working in a commercial environment preferred.

Responsibilities

  • Execute equipment calibration, preventive maintenance, performance verification, and repair activities in laboratory and manufacturing areas.
  • Supervise vendors performing calibration, maintenance, and repair functions.
  • Review and approve vendor records for calibration, maintenance, repair, and performance verification for accuracy and compliance with Bristol-Myers Squibb standards.
  • Enter data into the site CMMS system and ensure records are filed appropriately after approval.
  • Write and support deviations resulting from calibration or performance verification failures, including developing and supporting corrective and preventative actions.
  • Support development, revision, and review of procedures for calibration, preventive maintenance, and performance verification.
  • Support development, review, and approval of calibration and maintenance plans, including asset induction requests/modifications in the site CMMS system.
  • Support execution of equipment performance verification and process improvement studies.
  • Adhere to all ECQ team policies and procedures to ensure compliance is held to the highest standard.
  • Promote and provide excellent customer service and support.
  • Regularly review, prioritize, and promptly respond to customer equipment performance verification and support requests.
  • Provide technical support and guidance on calibration, equipment performance verification, and validations issues.
  • Interface with customers to ensure all expectations are being met.
  • Maintain positive relationships with Equipment Commissioning & Qualification department members and site customers, promoting a positive team environment.
  • Work with planning group to ensure the system is updated as calibration, maintenance, and performance verification activities are performed.
  • Maintain required Corporate, Facilities, and EHS training.
  • Adhere to all safety procedures and hazard communication.
  • May act as SME in internal and regulatory 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.
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