Periode: 1 year, with possible permanent extension
Our client is a leading Project Management and Engineering Company serving industry around the world. Their reputation is based on forming successful partnerships with their clients, providing them with innovative designs and cost effective solutions in the context of sound judgment, strong management and technical excellence.
They provide Full Service Engineering for their clients including Project and Programme Management, Procurement, Design, Construction Management, Health & Safety Management, Commissioning, Qualification and Start-up on numerous projects across a range of market sectors.
As Process Engineer you will operate at the technical interface between the project team and the external drug product manufacturing sites. Your main responsibilities will be:
- Proper and timely execution of drug product manufacturing activities;
- Review of the (master and executed) batch documentation prepared by the manufacturing site and bringing it to the required quality level;
- Being physically present during drug product manufacturing (Person in Plant, PiP), resolving issues on the spot and guiding corrective measures if required;
- Establishing and maintaining a trustful and professional relationship with the external drug product manufacturing sites;
- Participating in the multidisciplinary project teams, ensuring alignment with project needs;
- Identifying and implementing improvements in the way of working;
- Being all-round expert in quality, regulatory, technical and business aspects of external manufacturing.
- MSc/BSc in pharmaceutical sciences or other relevant disciplines (i.e., pharmacy, (bio)chemistry).
- Pro-active, flexible and full of initiative.
- At least 5 years of experience (10 years for senior position) in vaccine and/or large molecule GMP drug product manufacturing.
- Experience with process development, project management and outsourcing is an advantage.
- English fluent, Dutch is preferred
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Neem contact op met Sander Pupella van ons kantoor te Zoetermeer, te bereiken op nummer 079-7973610