Senior, Cryopreservation Process Engineer CAR-T
Job in
Raritan, Somerset County, New Jersey, 08869, USA
Listed on 2026-09-14
Listing for:
Scorpion Therapeutics
Full Time
position Listed on 2026-09-14
Job specializations:
-
Engineering
Validation Engineer, Quality Engineering, Pharma Engineer -
Manufacturing / Production
Validation Engineer, Pharmaceutical Manufacturing, Quality Engineering
Job Description & How to Apply Below
Role
Senior Cryopreservation Process Engineer leading technical and operational aspects of cell processing and cryopreservation manufacturing within a GMP-regulated environment.
Responsibilities- support development, scale-up, technology transfer, facility design, startup, qualification, and operational readiness;
- optimize processes for cell and gene therapies;
- develop and implement GMP support procedures;
- lead process validation, risk assessment, and change control strategies;
- oversee equipment qualification, manufacturing IT systems, and continuous improvement initiatives;
- act as a technical expert during inspections and troubleshooting;
- collaborate across functions to ensure scalable, compliant, and cost-effective manufacturing.
- Bachelor's degree in Engineering, Bioscience, or related field;
- minimum 4 years’ experience in cGMP manufacturing, process development, validation, or quality management;
- strong understanding of aseptic processing, cell/gene therapy manufacturing, and GMP regulations.
experience in cell/gene therapy (CAR-T), equipment CQV, technology deployment, and continuous improvement methodologies like Lean or Six Sigma.
High Valueexpertise in cell/gene therapy manufacturing, cryopreservation, GMP operations, validation, and automation systems.
Work Setupbased in Raritan, NJ, with an emphasis on cross-functional collaboration and operational excellence.
Position Requirements
10+ Years
work experience
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