Risk Business Partner HNC

Today, Lonza is a global leader in life sciences operating across three continents. 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 ideas that help businesses 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.

The MES Recipe Modeler is responsible for designing manufacturing processes in MES Systems and preparing the required documentation for manufacturing, according to applicable guidelines. At the same time, the role ensures shop floor support on MES related issues and manufacturing problems. Other focus areas are acting as interface between Manufacturing and IT / OT and providing general support on MES Topics. MES SME (Subject Matter Expert) in Business area represents actively this area in related projects. The incumbent will be involved in the definition and testing of the processes in the MES system while being responsible for maintaining updated the SOP associated to the MES system.

Key responsibilities:

1. Work closely with MES manager, system users and process owners to develop and revise MES recipes in a timely manner.
2. Configure production recipes using a library of objects and manage MES master data like Products, Locations, Equipment, Materials.
3. Assist in fulfilling requirements of quality records such as process change controls, CAPA and deviations.
4. Draft and execute test script for the validation of recipes (IQ, OQ, PQ).
5. Establishment and further development of interfaces to other systems such as ERP, LIMS and automation and work closely with these departments.
6. Support floor activities as required to bring running records to successful process conclusion.
7. Work closely with Process Automation and MES Analysts to develop and revise Controls Logic, batch records and other MES records in a timely manner.
8. Development of concepts for an optimal data flow with the interfaces, taking into account all use cases.
9. Definition of requirements for the MES system for its further development.
10. Support production via the Helpdesk, assisting with production issues.
11. Author training material and execution of training related to MES.
12. Preparation and support for audits and inspections.
13. Deputy Process Owner.

Key requirements:

1. Academic degree (minimum Bachelor) preferred in a technical field and/or engineering.
2. Proven process understanding in Sterile Manufacturing (Pharma, regulatory aspects).
3. Familiarity with GMP requirements, quality procedures and SOP execution.
4. Good communication skills and interaction with a variety of interfaces within the organization and the shop floor.
5. Strong team orientation.
6. Structured and proactive working attitude.
7. Self-driven and result-oriented.
8. Proven IT knowledge, knowledge in SAP and MES Systems.

Every day, Lonza’s products and services have a positive impact on millions of people. For us, this is not only a great privilege, but also a great responsibility. How we achieve our business results is just as important as the achievements themselves. At Lonza, we respect and protect our people and our environment. Any success we achieve is no success at all if not achieved ethically.

People come to Lonza for the challenge and creativity of solving complex problems and developing new ideas in life sciences. In return, we offer the satisfaction that comes with improving lives all around the world. The satisfaction that comes with making a meaningful difference.

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