Our client is a global leader in healthcare and pharmaceutical products, with base in Leiden. Their mission is to transform individual lives and fundamentally change the way diseases are interpreted, managed and in the end prevented. In over 150 countries the company is bringing innovative science and together with the most creative minds in the industry. This site is responsible for validation and standardization of processes and equipment within sites and manages Life Cycle Management and improvement projects.
As a Process Engineer you will work on Continued Process Verification and you will be part of the new material introduction project team; introducing materials such as new filters, tubing and containers. Technical Operations is responsible to execute the polymeric risk assessment for new incoming materials and supplies based on vendor availability. Materials an supplies being used in manufacturing process will be updated and replaced based on vendor availability.
- Risk assessment for new incoming materials and supplies
- Responsible for writing continued verification process reports
- Data gathering, data analysis and reporting
- Updating CPV procedures when needed
- Troubleshooting data excursions when needed
- Bachelor or Master in Science
- Minimal 5 years' of relevant experience in the (bio-)pharmaceutical industry
- Proven experience with GMP and compliance
- Proven statistical knowledge and experience
- Fluent in English, Dutch is a plus
The perfect candidate for this role is eager to learn, good collaborator and is flexible and agile in fast responding to change in requests.