Job Responsibilities
1. Set up, practical execution and troubleshooting of upstream, downstream and support unit operations in continuous manufacturing and fed-batch processes under Good Manufacturing Practices (GMP)
2. Knowledge of and compliance to GMP principles and EHS standards in the area of responsibility
3. Management and documentation of process execution, deviations, changes and CAPAs. Partnering with Quality Assurance and other internal stakeholders during investigations and technical discussions
4. Involvement in continuous improvement efforts and support for the implementation of new technologies, including non-GMP engineering runs or testing activities
5. Creation and updates of SOPs and (electronic) master batch records. Technical review of various documentation related to process transfer and GMP manufacturing
6. Material management using ERP systems (SAP)
7. Participation in sampling activities or on-call duties, which may include weekend work
Minimum Requirements
1. A bachelor’s or master’s degree in a relevant discipline
2. Experience in a GMP environment in the pharmaceutical or biotech industry
3. Experience with quality management and compliance systems (Trackwise/SAP QM/VeevaVault)
4. Familiarity with the use of automated systems in manufacturing (DeltaV) or electronic batch records (MES)
5. Prior experience with process development or process scale-up is beneficial
6. Ability to work efficiently as part of a team, as well as willingness to take responsibility for independent projects
7. General knowledge of unit operations in manufacturing processes for biologics.
8. Ability to solve problems and take new perspectives on existing solutions with a desire to continuously learn, improve and develop.
9. Business Fluent in English and German: Effective oral/written communication skills in English (C1) / Oral/written communication skills in German (B2)
Company Overview
International environment. Top Employer in Switzerland.
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