Process Engineer (Cell and Gene Therapy) | Verfahrensingenieur (m/w/d)

Job Summary

This role involves joining ProBioGen, an international BioTech company based in Berlin, specializing in the development and manufacturing of biopharmaceutical active ingredients and vaccines. The Process Engineer will play a pivotal role in the planning, construction, and commissioning of a new production facility for Cell and Gene Therapy, which ProBioGen will operate. Key responsibilities include defining technical specifications (requirements catalogs), selecting, purchasing, and commissioning necessary equipment for cell therapy, as well as Upstream Processing (USP) and Downstream Processing (DSP) for gene therapy products. A significant part of the job involves planning and overseeing the qualification of this equipment, including Factory Acceptance Tests (FAT), Site Acceptance Tests (SAT), Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ). The ideal candidate must hold a Master's degree in Bioprocess Engineering or Biotechnology, possess experience in equipment qualification and plant planning, and have foundational knowledge of GMP environments. This position offers a chance to drive innovation in life-saving medical therapies within a highly collaborative setting.