Manufacturing Operations Specialist
Vor 6 Tagen
The selected candidate will be responsible for the following task area:
- Executes and troubleshoots manufacturing processes under GMP regulations
- Ensures compliance with GMP and EHS standards
- Documents process execution, deviations, and changes; collaborate with Quality Assurance
- Supports process improvements and new technology implementation
- Manages SOPs, batch records, and technical documentation
- Handles material management using ERP systems (SAP)
- Mentors junior team members and facilitate knowledge transfer
- Participates in sampling activities and on-call duties, including weekend
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
- Willingness to work on weekends as required
A challenging and rewarding position in a globally recognized company.
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