MES System Engineer GMP/CSV for Digital Manufacturing

Proclinical; Oberwallis; Vor Ort; CHF 100.000 - 140.000; Vollzeit

Zusammenfassung

Proclinical is seeking a MES System Engineer (EI&C) for a contract role based in Switzerland. The role focuses on maintaining MES standards, supporting operations, and ensuring regulatory compliance to drive digitalization in manufacturing.

The successful candidate will collaborate across Automation, IT, Validation, Quality, and Manufacturing teams, contribute to lifecycle management of MES platforms such as PAS-X, Syncade, PharmaSuite, and Opcenter, and ensure data integrity and

Qualifikationen

• Degree in Automation Engineering, Information Technology, Computer Science, Electrical Engineering, or a related technical field.
• Experience with MES, Manufacturing IT, OT, or automation systems in a GMP-regulated pharmaceutical, biotech, or life sciences environment.
• Strong understanding of manufacturing processes, batch execution, and electronic records management.
• Familiarity with GAMP, GMP, data integrity, and computerized system validation (CSV) practices.
• IT-OT background with knowledge of manufacturing system architectures.
• Fluency in English and/or German.

Aufgaben

• Maintain, govern, and enhance MES standards, templates, best practices, and system architectures across manufacturing sites.
• Provide technical support for MES operations, including troubleshooting, performance monitoring, incident resolution, and system optimization.
• Support MES enhancements, upgrades, deployments, and lifecycle management activities.
• Ensure GMP-compliant electronic batch records, manufacturing workflows, and system documentation are maintained per regulatory requirements.
• Develop and review GxP documentation, including specifications, risk assessments, test documentation, change controls, and SOPs.
• Collaborate with Automation, IT, Validation, Quality, and Manufacturing teams to implement and maintain MES solutions aligned with business needs.
• Support integration of MES with automation systems, historians, ERP platforms, and other manufacturing applications.
• Participate in commissioning, qualification, validation, and system release activities.
• Analyze manufacturing processes to identify opportunities for digitalization, standardization, and continuous improvement.
• Ensure system reliability, data integrity, cybersecurity, and compliance with company standards and regulatory expectations.
• Support audits, inspections, and periodic reviews related to MES systems and electronic records.

Kenntnisse

MES expertise

GxP knowledge

IT-OT background

Regulatory compliance

Ausbildung

Degree in Automation/IT/CS/Electrical

Tools

PAS-X

Syncade

PharmaSuite

Opcenter

VMware

Jobbeschreibung

Proclinical is seeking a MES System Engineer (EI&C) for a contract role based in Switzerland. The role focuses on maintaining MES standards, supporting operations, and ensuring regulatory compliance to drive digitalization in manufacturing.

The successful candidate will collaborate across Automation, IT, Validation, Quality, and Manufacturing teams, contribute to lifecycle management of MES platforms such as PAS-X, Syncade, PharmaSuite, and Opcenter, and ensure data integrity and