Senior Bioprocess Engineer m/f/d,We are seeking a process engineer with a solid experience within the biopharmaeutical industry.
Your responsibilities: - Manage operational activities in Upstream and Downstream or BioConjugates manufacturing, e.g. tech transfer support, material planning, document and batch record preparation, training and troubleshooting, deviation handling
- Role out of new SAP functionality, a strong expertise in Change Management documentation as well as thorough updates of manufacturing documentation (e.g. SOPs, batch records) is key
- Functional lead for an interdisciplinary team of production personnel, supervisors and specialists
- Establish training documentation for manufacturing personnel
- Guide and support activities for clinical and/or commercial manufacturing in one or more defined DSP areas, e.g. capture, intermediate purification, polishing or drug substance filling
- Ensure implementation of procedures which enable efficient operation of single-use and/or stainless steel equipment for the purification of therapeutic proteins from either microbial or mammalian expression systems
Key requirements: - Bachelor, Master's Degree or PhD e.g in Biotechnology, Biochemistry
- Significant work experience in Manufacturing in the biotech/biopharma industry
- Very good GMP understanding, strong experience in SAP, aspects of material management (BOM)
- Profound knowledge as End-User of MES
Excellent communication skills in English and German
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