About the Company:
Our client is one of the leading biotechnology companies in the world. Their mission is to cure any patient, no matter how severe their situation is. For over 40 years, their team of scientists have been working on developing innovative treatments in the areas of oncology, hematology, nephrology and others.
Their headquarters are located in Noord-Brabant, Netherlands. Here, they are responsible for packaging pharmaceuticals and distributing them across the whole EMEA region.
In this role you will be part of a team responsible for deploying, maintaining and implementing changes in computerized systems in manufacturing (MES, LIMS, ERP etc) and plays a central role in the digitalization of manufacturing in commercial manufacturing site.
Your responsibilities- Understand the process and user requirements driven by process maps / flows in preparation for developing or updating EBR designs
- Convert process and user requirements into specific EBR designs and design elements.
- Drive and support EBR design verification activities
- Manage EBR approval and retirement workflows to ensure correct record state
- Lead MES projects and change implementations
- Escalate business continuity impacting issues to Process Owner and respective tier
- Support EBR impact assessments based on the manufacturing/business process requirements and changes
- Identify and document MES (business) and manufacturing process requirements.
- Create and update Process SOPs, MES SOPs, and MES work instructions
Your profile- Bachelor’s degree or equivalent experience
- 5 years’ relevant (process engineer/MES specialist) experience within a Pharmaceutical/GMP Manufacturing site
- Experience with writing and execution of CSV documentation / protocols
- Experience with quality systems (change controls, deviations and CAPAs) in a pharmaceutical environment
- Knowledge of PAS-X version 3 is a plus
- Experience with SQL and XML coding with respect to MES is a plus
- Knowledge of the MES database and data elements as part of querying and reporting is a plus
- Good English language skills
If you are interested or need more information about this role don’t hesitate to contact us! If you want to apply right away click on the button below.