Biologics Process Expert
vor 8 Stunden
We are looking for a talented Process Engineer - II - P2 Specialist, Manufacturing Operations to join our team. As a key member of our Manufacturing Operations team, you will play a critical role in supporting GMP manufacturing activities.
Key Responsibilities- Develop and implement process improvements to ensure seamless integration within the existing team.
- Collaborate with Quality Assurance and other internal stakeholders to manage documentation for process execution, deviations, changes, and CAPAs.
- Support the implementation of new technologies, including non-GMP engineering runs or testing activities.
- Develop and maintain SOPs and electronic master batch records, as well as review technical documentation for process transfer and GMP manufacturing.
- Manage material using ERP systems (e.g., SAP).
- Train and mentor junior team members and actively participate in knowledge transfer.
- Participate in sampling activities or be on-call, including potential weekend duties.
- Educational background in a relevant discipline.
- 2-5 years of experience in the pharmaceutical or biotech industry.
- Minimum of 2 years of practical experience in the GMP manufacturing of biologics (upstream or downstream).
- Expert knowledge in specific unit operations for biologics manufacturing.
- Understanding of GMP principles and ability to work under pressure in a complex environment.
- Fluent English communication skills (C1 level).
- Intermediate German skills (B2 level). Candidates with German A1/B1 proficiency may be considered if other skills strongly align with the role.
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Vor 2 Tagen
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GMP Operations Expert
vor 22 Stunden
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vor 8 Stunden
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