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