Process Engineer

Beschreibung

Process Engineer



Our biopharmaceutical manufacturing client has undertaken a large expansion of its manufacturing facilities to allow for its first commercial production runs. They are looking for process engineers to support them during the full life cycle of the project. You will be involved with process design, GMP compliance, drafting (Quality) documents, organizational matters, development and practical execution. This is a dynamic and challenging assignment with both a technical component and a strong emphasis on driving quality compliance.



The Role:



- The design, and implementation, evaluation, documentation and reporting of commissioning, qualification and validation studies of processes for the expansion project.

- The processes and equipment involved include fermentation, chromatography, UF, bioreactors and centrifuges.

- Contribute to troubleshooting for process-related problems.

- Represent results in a clear way to capture information for drafting, study protocols and research reports.

- Maintaining discussions with suppliers on technical content areas.



 Requirements:



- Knowledge of bio-manufacturing or bio-technology production environments is essential.

- Knowledge of advanced process equipment and production processes for upstream or downstream production in fermentation, chromatography, UF, bioreactors and centrifuges.

- Experience working to tight project schedules and deadlines.

- Both a strong team player and able to work independently.

- Strong GMP and FDA knowledge.