About Our Client
Our client, a global leader in the pharmaceutical industry, is seeking a motivated Specialist to join their Manufacturing Operations team in the greater Lucerne area. This full-time, on-site role offers an exciting opportunity to contribute to the implementation and GMP manufacturing of early-phase clinical therapies in a collaborative and forward-thinking environment.
Job Description
The selected candidate will be responsible for the following task area:
* 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.
The Successful Applicant
To be considered for this position, the ideal candidate must have:
* Successfully completed an academic degree in a related field.
* At least 1-3 years of working experience in the pharmaceutical or biotech industry, with experience in GMP biologics manufacturing (upstream or downstream processing).
* Hands-on experience with quality management systems such as Trackwise, SAP QM, or VeevaVault.
* Familiarity with DeltaV and electronic batch record systems (MES).
* Excellent command of English (both written and oral); good German skills (level B1) are required.
* Prior involvement in process scale-up or technology transfer.
* A proactive, reliable, and independent approach to work.
What's on Offer
A challenging and rewarding position in a globally recognized company.
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