Downstream Process Transfer Engineer | Biologe (m/w/d)
Randstad Professional
Job Summary
This role involves leading complex transfer projects for early and late-stage biologicals within a global pharmaceutical environment in Biberach. As a Downstream Process Transfer Engineer, you will be responsible for the high-quality creation of transfer documentation, including process descriptions, facility fit analyses, and risk assessments, while ensuring compliance with international regulatory guidelines. You will manage product transfer activities for clinical production facilities focusing on purification (downstream) and serve as a technical expert for biopharmaceutical manufacturing. The position is highly collaborative, requiring you to interface with internal development teams, commercial production sites, and external contract manufacturing clients. This is an attractive opportunity for a professional looking to work at the intersection of science and project management, offering a permanent contract with a leading global personnel service provider and a chance to represent critical projects in cross-functional international meetings.
Required Skills
Education
University degree in Biology, (Bio-)Chemistry, (Bio-)Pharmacy, Bioinformatics, or a comparable qualification with relevant professional experience.
Experience
- Professional experience in biopharmaceutical manufacturing processes (Upstream or Downstream)
- Experience in the development and production of biologicals
- Proven track record in project management within a pharmaceutical context
- Experience in creating regulatory documents and responding to authority inquiries
- Several years of relevant professional experience if applying with a non-degree equivalent qualification
Languages
Additional
- Must have a deep understanding of GMP-regulated environments. Role requires the ability to manage site-to-site process transfers within a global biopharma network.
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