The Technical Engineer will be responsible for managing and coordinating all commissioning and qualification activities within the investment projects in order to deliver qualified systems, according to cGMP, and monitoring the quality of these activities. Acts as subject matter expert in projects for C&Q related issues, under direction of a project manager. Is responsible for the commissioning and qualification of systems and therefore is in charge of the C&Q teams composed of representatives of relevant departments, like local QA, QC's, technical supporting groups and stakeholders. Is responsible for the C&Q management, including planning, C&Q deliverables and setting out C&Q related strategies. Writes Validation Project Plans, project close-out Validation Project Reports. Writes protocols and summary reports and performs qualification activities on the basis of the protocols or have them being written and or performed by others. Assesses independently whether equipment or systems should be qualified and reviews this with QA. Reviews commissioning and qualification documents established by others or by external companies and has these documents to be changed according to his insights. Supervises and controls C&Q activities carried out by third parties. Reviews turn over packages established by suppliers. Is asked for monitoring developments on relevant C&Q guidelines and communicate them within the C&Q group.
MSc or experienced BSc degree in (Bio)chemical Engineering, Biochemistry, Applied Science. Strong analytical skills, ability to understand automated process systems. Excellent communication skills. Team player. Willing to travel. Willing to work outside office hours. Preferably experience in the food or (bio)pharmaceutical industry, as a technical or C&Q engineer or production supervisor. Good writing and planning skills. Fluent in English and Dutch, German is a plus.
XDES projects is specialist in recruitment van technisch personeel.