Process Development Engineer

GenDx, experts in transplant diagnostics

GenDx is a global leader in molecular diagnostic laboratory solutions for high resolution tissue typing of both donors and patients and monitoring transplant success. We combine our cutting-edge software solutions, reagents for DNA sequencing-based HLA typing, and Chimerism monitoring strategies with our excellent customer support including a comprehensive education program. Our products are sold all over the world through direct sales and distributors. The GenDx office is based at Utrecht Science Park in The Netherlands, and we have an office in Chicago, IL, USA. Since 2022, GenDx is 100% owned by French entity Eurobio Scientific SA.

With a highly educated and motivated team of about 100 colleagues, we contribute to the quality of life of transplant patients.

The Process Development Engineer at GenDx ensures a smooth implementation of new or changed products into the production pipeline. Also, you drive upscaling and improvements of processes. By setting up new production processes, or adjusting current processes, you ensure that product designs can be produced on a large scale while still maintaining the high quality specifications that our diagnostics tests require. You work closely together with the Production Manager to discover what is needed and which studies need to be performed to create a stable product and process.

To accomplish this, you are creative, detail oriented and you take initiative with a hands-on mentality. Familiarity with setting up automated processes is a plus.

Responsibilities

• Designing and upscaling manufacturing processes
• Managing process development projects and staffing
• Training of personnel on processes
• Troubleshooting regarding manufacturing issues
• Creating and adjusting documentation for processes
• Working according to ISO 13485 standards