Process Expert, Drug Product 80-100%
On-siteStein, Aargau, Switzerland
Job Summary
Lead technical troubleshooting on an aseptic filling and lyophilization line, ensuring efficient and effective production while establishing and maintaining good cleanroom management practices. Coordinate and support the qualification of the manufacturing line from PQ through Swissmedic approval, identifying weaknesses and determining solutions to fix or investigate issues. Drive and maintain process improvements by collaborating with team members and internal functions such as MSAT and QA to implement new processes. Manage deviations and train Operators on the line as the technical expert for this brand-new ADC production environment.
Required Qualifications
- Degree or equivalent experience in Life Science or Engineering
- Proven experience in EITHER aseptic filling or aseptic manufacturing in the GMP controlled environment
- Proficiency in English
- Ability to agilely move between various tasks during this dynamic and exciting project phase
Desired Qualifications
- Experience in the qualification of manufacturing equipment
- Experience with lyophilization processes
- German language skills
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