Onsite Bioprocess Engineer – GMP Biopharmaceuticals, Upstream Processing

Posted 16 hours ago

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About the role

  • Biomedical engineer focusing on upstream processing for biopharmaceuticals at Fraunhofer IZI. Responsible for project planning and execution in GMP environments located in Leipzig.

Responsibilities

  • Responsibility for planning and implementing complex projects within a GMP environment
  • Projects focused on the upstream processing of biopharmaceutical products — from internal coordination and project management, through material and procurement planning, to communication with external partners
  • Design and support of the introduction of new upstream processes and further development of manufacturing workflows
  • Preparation of the necessary technical documentation according to GMP standards and ensuring traceability and quality of all process steps
  • Close collaboration with the team’s downstream and fill‑finish engineers on larger cross‑functional projects

Requirements

  • A completed university degree in natural sciences or engineering, e.g., Biotechnology, Pharmaceutical Engineering, Bioprocess Engineering/Biosystems Engineering, or a related field
  • Practical experience working in cleanrooms (including cleanroom class A) and under GMP conditions
  • Good knowledge of regulatory requirements in the GMP environment, in particular the EU GMP Guideline Annex I
  • Confident handling of mammalian cell cultures and operation of wave reactors and stirred‑tank bioreactors up to 200 liters
  • Good German language skills for documentation tasks and good English skills for communication with international project partners

Benefits

  • 30 days’ annual leave based on a 5‑day workweek (Christmas Eve and New Year’s Eve are additionally days off)
  • Annual special payment/bonus
  • Compensatory time off for overtime
  • Company pension scheme
  • Capital‑forming benefits (employer contributions to employee savings plans)
  • Discounted Deutschland ticket for public transport
  • Free parking and secure bicycle parking with charging stations for electric vehicles
  • Discounted staff prices in the institute canteen

Job title

Bioprocess Engineer – GMP Biopharmaceuticals, Upstream Processing

Job type

Experience level

Mid levelSenior

Salary

Not specified

Degree requirement

Bachelor's Degree

Location requirements

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