Downstream Process Engineer | Germany | Freelance

Role Summary:

We are looking for a Process Engineering Lead with expertise in Downstream Processing (DSP) to join our team near Ulm, Germany. This position focuses on driving DSP initiatives across various ongoing projects within our biopharmaceutical manufacturing operations. With a steady pipeline of projects, we welcome both seasoned professionals and recent graduates with a strong foundation in DSP to contribute to and support multiple concurrent projects.

Key Responsibilities:

Project Leadership:

• Lead DSP process engineering activities, ensuring adherence to project timelines and deliverables.
• Coordinate cross-functional teams, including upstream processing, quality assurance, and regulatory affairs, to ensure alignment on project goals.

Process Design and Optimization:

• Develop and refine DSP workflows, including purification techniques such as chromatography, filtration, and viral clearance steps.
• Conduct experiments to validate process modifications, document results, and adjust protocols as necessary.

Documentation Management:

• Procedures (SOPs), batch records, and technical reports, ensuring compliance with regulatory standards.
• Ensure that all documentation is completed in German and adheres to Good Manufacturing Practices (GMP).

Day-to-Day Operations:

• Oversee the execution of DSP processes, including buffer preparation, chromatography runs, ultrafiltration, and diafiltration operations.
• Monitor critical process parameters (e.g., pH, conductivity, flow rate) during manufacturing runs, ensuring adherence to established specifications.
• Manage troubleshooting and resolution of operational issues, working closely with the production team to implement corrective actions.

Collaboration with Upstream Processing (USP):

• Provide technical support for upstream processing as needed, assisting in scale-up activities and integration of DSP requirements into upstream workflows.
• Ensure that all DSP activities comply with relevant industry regulations, including GLP and GxP standards.
• Prepare for and support audits, inspections, and regulatory submissions by maintaining accurate and up-to-date documentation.

Qualifications:

• Educational Background: Bachelor’s or Master’s degree in Chemical Engineering, Bioprocess Engineering, Biotechnology, or a related field.
• Professional Experience: A strong background in Downstream Processing is required, with a preference for candidates who have experience in contract-based or high-volume project environments. Familiarity with biopharmaceutical manufacturing processes is advantageous.
• Language Skills: Fluency in German is essential for documentation and communication purposes. Proficiency in English is highly valued, as it will facilitate collaboration with international teams.

This role offers a unique opportunity to join a dynamic, project-driven team with a continuous demand for skilled DSP engineers. If you are eager to leverage your process engineering expertise in an environment that promotes professional development and diverse project work, we encourage you to apply.