MSAT - Process Engineer

Job requirements

• Ensuring technology transfer from and to production by being the production representative in the relevant project core-team(s) by ensuring that the execution of the production (associated) work within the company is scientifically and technologically correct, efficient, and cost-competitive (within the boundaries of SHE and cGMP requirements, as well as client´s expectations);
• Ensuring life-cycle management of a process from transfer, via process validation to continuous process verification;
• Ensuring, if needed, process related support to shop-floor for production activities.

Qualifications Required

• Academic or HLO level - bioprocess field of expertise;
• Working for 5 years or more in a (Bio-) pharmaceutical environment or in a relevant (bioprocess) research field;
• Extensive knowledge of (bio)pharmaceutical processes with experience in downstream processing, specifically protein / polysaccharide purification;
• Document writing skills in English;
• At ease in project teams, interacting with clients, training colleagues, working in matrix structures;
• Application knowledge of GMP standards (writing batch documentation and SOPs);
• Familiar with process validation, trending, data analysis;
• Capability to coordinate and perform technology transfer and process validation activities within the manufacturing organization;
• Capability to prepare accurate documentation (batch documentation, validation documentation, scientific reports);
• Capability to resolve problems;
• Capability to summarize and present complex information in an audience-appropriate format (operators, clients, management etc.);
• You reside in and are eligible to work in The Netherlands (valid work permit).