Description
Our client is one of the world leaders in pharmaceuticals for animals. At their campus based in the Netherlands, they have one of the biggest production sites and houses also research and development departments.Within the Engineering Division, they are responsible for the realisation and management of critical investment projects in the worldwide network. Other tasks of the Engineering Division are consultancy activities and troubleshooting.
Job Description:
The Sr. Q/V Engineer will be responsible for managing and coordinating all 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 qualification related issues, under direction of a project manager or Q/V manager.
-Is responsible for the qualification of systems and therefore is in charge (validation leader) of validation teams composed of representatives of relevant departments, QA, QC`s, CTS and stakeholders within ED.
-Is responsible for the qualification management, including planning.
-Writes Validation Project Plans (VPP) and Validation Project Reports (VPR).
-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 / systems should be qualified and reviews this with QA.
-Assesses by others within ED or by external companies established qualification documents and let these documents may change according to his insights.
-Supervises and controls validation activities carried out by third parties.
-Assesses validation packages established by suppliers.
-Is asked for monitoring developments on relevant validation guidelines and communicate them within the Q/V group.
-Can be involved as executive in international investment projects.
Job Criteria:
-Msc or experienced BSc degree in (Bio)chemical Engineering, Biochemistry, Applied Science.
-Strong analytical skills, ability to understand automated systems.
-Excellent communication skills.
-Team player.
-Willingness to travel.
-Preferably experience in the food or pharmaceutical industry, as an engineer or
production supervisor.
-Good writing and planning skills.
-Fluent in English and Dutch.