MES Engineer - Biologics: Batch Records & PAS-X

nemensis ag Schweiz; Luzern; Vor Ort; CHF 90.000 - 120.000; Vollzeit

Zusammenfassung

nemensis ag Schweiz in Switzerland seeks an MES Engineer (m/f/d) to own configuring, building, and maintaining MES (PAS-X) recipes and GMP batch records in line with design standards within a Biologics Manufacturing facility located in Schachen, Canton of Lucerne.

You will provide hands-on troubleshooting for electronic batch record execution and support MES integration with SAP systems, while contributing to change controls, SOP updates, and MES training for end users.

Qualifikationen

• Bachelor's degree in Life Sciences or equivalent hands-on experience in MES environments.
• 2–3 years of MES experience in Biologics/Pharma manufacturing.
• Familiarity with computer system validation / SDLC principles and change control (GAMP 5).

Aufgaben

• Configure, build, and maintain MES (PAS-X) recipes and GMP batch records according to design standards.
• Provide hands-on troubleshooting and day-to-day support for EBR execution in manufacturing operations.
• Contribute to investigations and deviations by identifying and resolving MES-related issues.
• Prepare, test, and document system changes to support GMP batch record releases.
• Draft and progress Change Controls with senior engineers.
• Support MES integration with site automation layer and SAP-based systems.
• Develop and update SOPs and training materials; deliver MES training to end users.
• Support tech transfer activities from an MES perspective as new processes move into production.

Kenntnisse

English communication

PAS-X knowledge

Ausbildung

Bachelor's degree in Life Sciences

Tools

PAS-X

Jobbeschreibung

nemensis ag Schweiz in Switzerland seeks an MES Engineer (m/f/d) to own configuring, building, and maintaining MES (PAS-X) recipes and GMP batch records in line with design standards within a Biologics Manufacturing facility located in Schachen, Canton of Lucerne.

You will provide hands-on troubleshooting for electronic batch record execution and support MES integration with SAP systems, while contributing to change controls, SOP updates, and MES training for end users.