Our client is one of the global leader in healthcare and pharmaceutical products, with base in Leiden. The company focuses on the discovery, development, manufacture, and marketing of monoclonal antibodies to protect people worldwide from immunological diseases.
As a Technical Manufacturing Specialist, you will be responsible for the availability and robustness of the assigned equipment. In this role you will provide direct support and lead root cause analysis for operations when there is a problem.
- Ensuring production equipment is in validated condition
- Ensuring that documentation and software recipes are up to date, properly maintained and capacity full
- As equipment owner, process equipment related reports and KPIs
- Acute troubleshooting & support of the production of cGMP batches
- Taking the lead in root cause investigations of low to medium complex deviations and for the implementation of preventive actions.
- Initiate and handle compliance records (change control, events, CAPA, deviations)
- Bachelor's degree in Biotechnology or equivalent education
- Certified Green Belt
- Working experience with cGMP environment and EHSS standards
- Experience in software recipe writing
- Strong communication in Dutch and English
For more information please apply below and Zekiye will soon contact you.