Manufacturing Operations Specialist
Vor 3 Tagen
The selected candidate will be responsible for the following task area:
- Responsible for setting up, operating, and troubleshooting upstream and downstream processes in continuous and fed-batch manufacturing under GMP guidelines.
- Ensures adherence to GMP and EHS standards by accurately documenting processes, managing deviations, changes, and CAPAs, and collaborating with Quality Assurance and other stakeholders.
- Drives process optimization initiatives and supports the integration of new technologies through non-GMP engineering runs and testing activities.
- Prepares and maintains SOPs and electronic master batch records while performing technical reviews of GMP documentation.
- Manages materials using ERP systems such as SAP to ensure an efficient workflow.
- Participates in sampling activities and is available for on-call duties, which may include occasional weekend work.
To be considered for this position, the ideal candidate must have:
- Successfully 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.
A challenging and rewarding position in a globally recognized company.
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