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Manufacturing Operations Expert
vor 1 Woche
We aim to find a skilled Manufacturing Operations specialist to join our client's team in Lucerne.
This challenging role involves contributing to the implementation and GMP manufacturing of early-phase clinical therapies in a collaborative environment.
Key Responsibilities:
- Setting up, operating, and troubleshooting upstream and downstream processes in continuous and fed-batch manufacturing under GMP guidelines.
- Ensuring adherence to GMP and EHS standards by accurately documenting processes, managing deviations, changes, and CAPAs, and collaborating with Quality Assurance and other stakeholders.
- Driving process optimization initiatives and supporting the integration of new technologies through non-GMP engineering runs and testing activities.
- Preparing and maintaining SOPs and electronic master batch records while performing technical reviews of GMP documentation.
- Managing materials using ERP systems such as SAP to ensure an efficient workflow.
- Participating in sampling activities and being available for on-call duties, which may include occasional weekend work.
Requirements:
- Academic degree in a relevant field.
- 1-3 years of experience in the pharmaceutical or biotech industry, with experience in GMP biologics manufacturing.
- Experience with quality management systems such as Trackwise, SAP QM, or VeevaVault.
- Familiarity with DeltaV and electronic batch record systems (MES).
- Excellent English language skills and good German skills (level B1).
- Prior involvement in process scale-up or technology transfer.
- A proactive, reliable, and independent approach to work.
