Description
Our client, one of the world leaders in pharmaceuticals for animals, currently have an urgent requirement for a Senior Qualification/ Validation Engineer to work from their large manufacturing facility in Southern Holland.This division of the business is responsible for the realisation and management of critical investment projects in the worldwide Animal Health network. Other tasks are consultancy activities and troubleshooting.
Job Description:
The Senior 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 ES.
-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 ES 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.
Requirements:
-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.
This is an excellent opportunity to work in a Senior leadership role with a world leading organisation with the scope for long-term work.
Please apply now for further information.