Fraunhofer-Gesellschaft

Bioprocess Engineer, GMP Biopharmaceuticals – Downstream Processing

Fraunhofer-Gesellschaft

full-time

Posted on:

Location Type: Office

Location: Leipzig • Germany

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About the role

  • Responsibility for planning and implementing complex projects in a GMP environment
  • Projects with a focus on the downstream processing of biopharmaceutical products — from internal coordination through project management, material and order planning to communication with external partners
  • Designing and supporting the introduction of new downstream processes
  • Providing technical supervision and guidance for technical staff
  • Preparing the necessary technical documentation in accordance with GMP standards

Requirements

  • A successfully completed university degree in natural or engineering sciences, e.g., Biotechnology, Pharmaceutical Engineering, Bioprocess Engineering/Biosystems Engineering, or a comparable discipline
  • Practical experience working in cleanrooms (up to and including cleanroom class A) and under GMP conditions
  • Good knowledge of regulatory requirements in the GMP environment, in particular the EU GMP Guide Annex I
  • Experience in process development for chromatography and filtration (depth filtration through sterilizing filtration), tangential flow filtration, and virus reduction/clearance
  • Confident handling of equipment for chromatographic purification and filtration of biomolecules
  • Good German language skills for documentation tasks and good English skills for communication with international project partners
Benefits
  • 30 days of vacation based on a 5-day week (Christmas Eve and New Year's Eve are additionally non-working days)
  • Annual special payment (year-end bonus)
  • Time off in lieu for overtime
  • Company pension scheme
  • Capital-forming benefits (Vermögenswirksame Leistungen)
  • A subsidized Germany Job Ticket for public transport (ÖPNV)
  • Free parking and secure bicycle parking with charging stations for electric vehicles
  • Discounted employee prices in the institute cafeteria
  • Diverse support offerings to help reconcile family and career (e.g., parent-child office, on-site childcare facility at the institute, care and coaching services from the pme family service)
Applicant Tracking System Keywords

Tip: use these terms in your resume and cover letter to boost ATS matches.

Hard Skills & Tools
project managementdownstream processingbiopharmaceutical productsprocess developmentchromatographyfiltrationtangential flow filtrationvirus reductiontechnical documentationGMP standards
Soft Skills
technical supervisionguidancecommunication
Certifications
university degree in natural sciencesuniversity degree in engineering sciences