Engineer focusing on Downstream Processing in GMP Biopharmaceuticals at Fraunhofer Institute in Leipzig. Responsible for project planning, implementation, and technical documentation under GMP standards.
Responsibilities
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)
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)
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