MES Expert Drug Product

Author and adapt MES/PCS Recipe based on the Drug Product Processes. Responsible for defining the overall concept for MES recipes used in Drug Product Operations Visp to ensure an easy and fast creation as well as adaption. Build and maintain relevant GMP documents (IQ, OQ, PQ etc.). Provide front line MES support, working with the manufacturing teams (operators), plant engineers and QA operations. Provide MES training for all end users. Act as Subject Matter Expert during customer audits and visits, maintain MES at inspection readiness level and provides support where needed. Lead process related investigations and critical deviations and assists in decision making on production issues. Lead process changes, CAPAs, and CAPA efficiency checks related to process within required timelines and through GMP systems (e.g. Trackwise, MES, training, etc.). Implements innovation and improvement projects comprising general manufacturing aspects for the production plant.

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.

• Studies in Pharmaceutical Technology/ Chemistry/ Pharmacy.

• Experience in MES recipe authoring, preferably in Emerson Syncade.

• Process knowledge in the area of sterile drug product is advantageous.

• Knowledge of DeltaV is preferable.

• Familiar with working in regulated environment, knowledge of cGMP, 21CRF part 11 and validation requirements.

• Proficient in both German and English is an asset.

• Familiarity with GMP requirements, quality procedures and SOP execution.

• Good interpersonal skills and interaction with a variety of interfaces within the organization and on the shopfloor.

• Structured, focused and well-organized working demeanor.

• Motivated and driven; with a problem-solving attitude.