Process Engineer MSAT (f/m/d)

Job responsibilities:

• 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 routine processes.

Qualifications required:

• Application knowledge of GMP standards;
• 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.);
• 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 if possible with experience in F&F / lyophilisation or protein / polysaccharide purifcation OR interest and experience in Intellectual Property topics related to  (bio)pharmaceutical processes;
• Application knowledge of GMP standards (writing of batch documentation and SOPs) and process validation;
• Document writing skills both in Dutch and English;
• At ease in project teams, interacting with clients, training colleagues, working in weak matrix structures;
• You reside in and are eligible to work in The Netherlands (valid work permit).