Biopharma Upstream Processing Specialist | Mitarbeiter*in Biopharma Upstream Processing (USP) (m,w,d)
Proclinical GmbH
Job Summary
This role involves supporting biopharmaceutical production within an Upstream Processing (USP) environment for a 1.5-year fixed-term contract. The successful candidate will perform GMP-compliant in-process control (IPC) analytics, such as measuring pH, osmolality, cell count, and viability. Key responsibilities include managing inoculum activities, cell cultivation, and maintaining rigorous GMP-compliant documentation in both paper and electronic formats. The specialist will also oversee specific IPC and inoculum equipment, including calibration and maintenance, while contributing to deviation management and SOP development. This position is ideal for a professional with a strong background in biotechnology or bioengineering who thrives in a highly regulated GMP environment, values quality standards, and enjoys mentoring new team members. You will work closely with cross-functional USP teams to ensure production efficiency and process improvement.
Required Skills
Education
Completed vocational training or degree in Biotechnology, Bioprocess Engineering, Bioengineering, Chemical Technology, or Pharmaceutical Technology; or a Master/Technician certification with relevant qualifications.
Experience
- Professional experience in Upstream Processing within a biopharmaceutical production environment
- Experience in GMP-regulated industrial production
- Practical experience with cell culture, inoculum, and IPC processes
- Experience with laboratory and production equipment qualification and maintenance
Languages
Additional
- Must adhere to GMP guidelines and safety regulations. Position is a fixed-term contract for 1.5 years located in the Ulm area.
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