IT/OT Business Systems Specialist

Supporting Laboratory (LIMS) & Manufacturing (MES, Track & Trace, Automation) Software and Systems in GxP regulated environments.
Experienced Data Integrity Specialist.
Incident & Problem Management
Life-Cycle Management
Software Validation, Configuration & Deployment. (Gamp5, CSV)
Systems Maintenance

I have a strong background in Support and Administration of Regulated Systems in GxP manufacturing including Projects, Upgrades, Critical Incident Management and security patching.
Additionally, I have Knowledge & Experience in Data Integrity and Implementing Data Integrity approaches on a site wide level.

I have experience in following GxP, Gamp5 & CSV procedures to ensure all systems are implemented in compliance with current regulatory requirements. I am used to working as part of a cross-functional teams to help ensure the delivery of projects and support the day-to day administration of Global & Site systems.
I have experience in drafting, devloping and excicuting various documentation, including SOP’s, Work Instructions, IQ/OQ/PQ & Knowledge Articles (KB’s). Additionaly I have experience in drafting, delivering and implementing site training.

I am currently working as MES Systems Administrator (MODA-ES) for Lonza NL

At Lonza, we enable #AHealthierWorld by supporting our healthcare customers on the path to commercialization. Our community of 16,000 talented employees work across a global network of more than 30 sites to deliver for our customers across the pharma, biotech and nutrition markets. By combining technological insight with world-class manufacturing, scientific expertise and process excellence, we help our customers to deliver new and innovative medicines that help treat a wide range of diseases. While we work in science, there’s no magic formula to how we do it. Our greatest scientific solution is talented people working together, devising commitment and ideas that help our customers to help people. In exchange, we let our people own their careers. Their ideas, big and small, genuinely improve the world. And that’s the kind of work we want to be part of. Our work makes #AMeaningfulDifference.