Senior Specialist QC, CAR-T ELM (1 of 2) in Raritan, New Jersey | DiversityInc Careers
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Senior Specialist QC, CAR-T ELM (1 of 2)

Janssen Research & Development, L.L.C., a division of Johnson & Johnson's Family of Companies is recruiting for a QC Equipment Lifecycle Management Specialist, CAR-T 1 of 2, located in Raritan, NJ.

At the Janssen Pharmaceutical Companies of Johnson & Johnson, what matters most is helping people live full and healthy lives. We focus on treating, curing and preventing some of the most devastating and complex diseases of our time. And we pursue the most promising science, wherever it might be found.

Janssen Research & Development, LLC discovers and develops innovative medical solutions to address important unmet medical needs in oncology, immunology, neuroscience, infectious diseases and vaccines, and cardiovascular and metabolic diseases. Please visit for more information.

We are Janssen. Our mission drives us. Our patients inspire us. We collaborate with the world for the health of everyone in it.

The QC Equipment Lifecycle Management Specialist, CAR-T executes all equipment lifecycle management projects for the QC organization.  This role performs duties for system user rights to support QC analysts. 

In this role, you will support facility qualification in support of testing requirements and release. This role also acts as the SME for the QC site data integrity initiatives.

Main responsibilities include but are not limited to:

  • Work with Process Development team, Quality and Operations organization to successfully transfer process to cGMP facility to manufacture products.
  • Supports Equipment lifecycle management – including appropriation, qualification, and maintenance and decommissioning  
  • Create, review and approve relevant QC documents, SOP’s and WI’s.
  • Act as point of contact for QC access rights for In-Process testing equipment. 
  • Perform tasks in a manner consistent with the safety policies, quality systems and cGMP requirements.
  • Other duties will be assigned, as necessary.

  • A minimum of a Bachelor’s degree in Engineering, Science or equivalent technical discipline is required. Master's degree is preferred
  • A minimum of at least 4 years within the biological and/or pharmaceutical industry with relevant micro experience related to manufacturing is required.
  • Quality Control experience is a must.
  • QC equipment experience in basic multi-color flow cytometry is required.
  • Aseptic processing in ISO 5 clean room and biosafety cabinets is required.
  • Knowledge of cGMP regulations and FDA/EU guidance related to manufacturing is required.
  • Cell based products as well as knowledge of Good Tissue Practices is preferred.
  • Detailed knowledge of routine and non-routine testing and sampling methods, techniques and related equipment is required.
  • Detailed knowledge of the shop floor manufacturing process is required.
  • Comprehensive knowledge of trending using statistical analysis.
  • The successful candidate must maintain written records of work in the form of notebooks, technical reports and protocols specific to lab equipment qualification is required.
  • This position will require occasional travel to Raritan, NJ or Spring House, PA as business demands
  • Candidates must be able to accommodate working outside normal business hours (including nights and weekends) on little to no prior notice
  • This position may require up to travel as business demands.

Do you strive to join an outstanding team that is dynamic and ever-changing? Is career growth and opportunity appealing to you? Apply to this opportunity today.

Johnson & Johnson Family of Companies are equal opportunity employers, and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, genetic information, national origin, protected veteran status, disability status, or any other characteristic protected by law.

Primary Location
United States-New Jersey-Raritan
Janssen Pharmaceuticals, Inc (6062)
Job Function
Quality Control
Requisition ID