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Sr Supervisor, QC Equipment Maintenance CAR-T

Req #: 1800856
Location: Summit, NJ US
Job Category: Quality
Work Location: 556 Morris Avenue CELSUMWEST 07901
Organization: Celgene Corporation
Schedule: 40
Employee Status: Full time
Job Type: Regular
Job Level:
Other Locations:US- NJ- Summit West


Celgene is a global biopharmaceutical company leading the way in medical innovation to help patients live longer, better lives. Our purpose as a company is to discover and develop therapies that will change the course of human health.  We value our passion for patients, ​quest for innovation, spirit of independence and love of challenge. With a presence in more than 70 countries, and growing - we look for talented people to grow our business, advance our science and contribute to our unique culture.

QC Sr Supervisor Equipment Maintenance, QC Systems and Services CAR-T

Summit, NJ

1.      Purpose and Scope of Position

The QC Senior Supervisor Equipment Maintenance is responsible for the management of all calibration and maintenance activities for all Quality Control equipment in support of analytical and microbiology CAR-T QC laboratories. This includes, but is not limited to, interfacing with SMEs, facilities, and vendors to facilitate equipment maintenance activities and the scheduling and performance of routine calibration activities in support QC equipment. The QC Senior Supervisor for Equipment Maintenance will serve as a backup for management as needed.

2.      Required Competencies: Knowledge, Skills, and Abilities

  • Advanced competency with computers and enterprise applications
  • Proficient in the use of LIMS, SAP, and BMRAM
  • Working knowledge of analytical and microbiology laboratory equipment. For example; Multisizer, Flow cytometer, BSC, BACTEC, etc.
  • Working knowledge of Lean Labs
  • Advanced ability to work in a collaborative team environment
  • Advanced ability to accurately and completely understand, follow, interpret and apply Global

Regulatory and cGMP requirements

  • Advanced problem-solving ability/mentality, technically adept and logical
  • Ability to adapt and adjust to changing priorities and to manage multiple assignments with challenging/conflicting deadlines
  • Ability to interact with regulatory auditors as a Subject Matter Expert (SME)
  • Ability to think critically to support quality decision making
  • Ability to do basic equipment troubleshooting
  • Ability to represent the interests of the QC group on cross-functional teams
  • Ability to set priorities for the equipment maintenance group and manage timelines
  • Ability to mentor and develop personnel

3.      Duties and Responsibilities

Manage equipment Calibration and maintenance

  • Responsible to ensure that all calibration and maintenance are performed for all QC lab equipment
  • Responsible for the maintenance of equipment calibration and maintenance records in accordance with cGMP requirements and written procedures
  • Responsible for the scheduling of equipment calibration and maintenance and to facilitate vendor visits for repairs, maintenance, etc.
  • Responsible for the performance of in-house maintenance activities including, but not limited to, incubator cleaning, freezer defrost and cleaning, etc.
  • Train laboratory personnel on the equipment calibration and maintenance processes.
  • Maintain all related SOPs

Function as QC equipment owner/SME

·      Responsible for QC activities as it relates to equipment change management

  • Collaborate with other departments for commissioning and decommissioning equipment

·      Assist management with investigations and deviations related to equipment

  • Responsible for the maintenance of equipment logs, equipment status labels, etc.
  • Function as primary support for equipment troubleshooting
  • Perform approvals for relevant equipment activities
  • Maintain equipment metrics

      Team Leadership

  • Manage personnel schedule as needed
  • Provide guidance and leadership
  • Assist management with the development, implementation and deployment of training
  • Serve as author or technical reviewer of appropriate departmental procedures
  • Perform approvals for relevant laboratory activities

      Performs other tasks as assigned.

4.      Education and Experience

  • Bachelor’s Degree required, preferable in Science
  • Advanced Degree preferred
  • 7-10 years of relevant work experience, preferable in a regulated environment
  • 3+ years leadership experience
  • An equivalent combination of education and experience may substitute

5.      Working Conditions

  • The incumbent will be working in a laboratory setting up to six (6) hours per day
  • The incumbent will be working around biohazardous materials, including chemical agents, up to six (6) hours per day
  • The incumbent will be working with equipment up to six (6) hours per day

This job description is intended to describe the general nature and level of work being performed by the person assigned to this positionThe primary duties and responsibilities are intended to describe those functions that are essential to the performance of this job.

This job description does not state or imply that the above are the only duties and responsibilities assigned to this positionThere are other duties and responsibilities that are considered incidental or secondary to the overall purpose of this jobEmployees holding this position will be required to perform any other job-related duties as requested by management.


Celgene is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, disability or veteran status. Celgene complies with all applicable national, state and local laws governing nondiscrimination in employment as well as employment eligibility verification requirements of the Immigration and Nationality Act. All applicants must have authorization to work for Celgene in the U.S.
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About Celgene

Celgene is a global biopharmaceutical company committed to improving the lives of patients worldwide. At Celgene, we seek to deliver truly innovative and life-changing treatments for our patients.

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