Manufacturing Operations Specialist
Vor 4 Tagen
To be successful in this role, you will need to have a strong background in aseptic and sterile pharmaceutical manufacturing, as well as expertise in process engineering and management. You will also need to have a proven track record of driving continuous improvement initiatives and supporting investigations related to process robustness.
Essential Qualifications:
- Advanced degree (Master's or PhD preferred) in Engineering, Biotechnology, or a related scientific field
- 9+ years of experience in aseptic/sterile pharmaceutical manufacturing, process engineering, or MSAT
- Expertise in isolator technology, single-use systems, filtration setup (including PUPSIT), and visual inspection (manual, semi-automated, and automated)
- Deep understanding of Annex 1 and sterility assurance principles within an operations or engineering setting
- Strong problem-solving skills with experience in GMP, process monitoring, and data analysis
- Fluency in German and English is required
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