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Manufacturing Operations Specialist
vor 1 Woche
We are seeking a highly skilled Process Engineer - II - P2 Specialist, Manufacturing Operations to join our team. This full-time, on-site position is focused on supporting GMP manufacturing activities and ensuring seamless integration within the existing team.
About the Role- Set up, execute, and troubleshoot upstream, downstream, and support unit operations in continuous and fed-batch manufacturing processes under GMP guidelines.
- Manage documentation for process execution, deviations, changes, and CAPAs while collaborating with Quality Assurance and other internal stakeholders.
- Contribute to continuous improvement initiatives and support the implementation of new technologies, including non-GMP engineering runs or testing activities.
- Create and update 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).
- Mentor and train 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.