GMP Manufacturing Engineer
vor 1 Tag
As a skilled Process Engineer - II - P2 Specialist, Manufacturing Operations, you will play a critical role in supporting GMP manufacturing activities and ensuring seamless integration within the existing team.
Responsibilities:
- Setting up, executing, and troubleshooting upstream, downstream, and support unit operations in continuous and fed-batch manufacturing processes under GMP guidelines.
- Managing documentation for process execution, deviations, changes, and CAPAs while collaborating with Quality Assurance and other internal stakeholders.
- Contributing to continuous improvement initiatives and supporting the implementation of new technologies, including non-GMP engineering runs or testing activities.
- Creating and updating SOPs and electronic master batch records, as well as reviewing technical documentation for process transfer and GMP manufacturing.
- Mentoring and training junior team members and actively participating in knowledge transfer.
Requirements:
- Relevant educational background.
- 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.
- Fluent English communication skills (C1 level).
- Intermediate German skills (B2 level).
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