MES Systems Engineer - Digitalization & GMP Compliance

ALTEN; Wallis; Vor Ort; CHF 90.000 - 150.000; Vollzeit

Zusammenfassung

ALTEN is seeking a skilled MES System Engineer to join our client's team, supporting maintenance, optimization, and continuous improvement of MES across manufacturing sites. You will ensure reliability, compliance, and efficiency of MES operations while collaborating with Automation, IT, Validation, Quality, and Manufacturing teams to drive digitalization and standardization.

The role emphasizes GMP-compliant electronic batch records, GxP documentation, and system lifecycle management, with a

Qualifikationen

• Fluency in English and/or German.
• Degree in Automation Engineering, Information Technology, Computer Science, Electrical Engineering, or a related technical field.
• Proven experience with MES, Manufacturing IT, OT, or automation systems in a GMP-regulated environment (pharmaceutical, biotech, or life sciences).
• Strong understanding of manufacturing processes, batch execution, and electronic records management.
• Experience with Manufacturing Execution Systems (e.g., PAS-X, Syncade, PharmaSuite, Opcenter, or similar).
• Experience with system implementations, enhancements, upgrades, and operational support.
• Experience with GxP documentation and change management processes.
• Familiarity with GAMP, GMP, data integrity, and computerized system validation (CSV) practices.
• Knowledge of OT infrastructure, industrial networking, virtualization (VMware), and server environments.
• Understanding of system integration concepts (MES, ERP, historians, automation platforms).
• Knowledge of cybersecurity principles in manufacturing environments.

Aufgaben

• Maintain, govern, and improve MES standards, templates, best practices, and system architectures to align with business and regulatory requirements.
• 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, workflows, and documentation.
• 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.
• Support the 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 and regulatory standards.
• Support audits, inspections, and periodic reviews related to MES systems and electronic records.

Kenntnisse

MES expertise

Cybersecurity principles

GxP/compliance knowledge

Data integrity

Change management

System integration concepts

Cross-functional collaboration

Ausbildung

Automation Engineering, Information Technology, Computer Science, Electrical Engineering

Tools

PAS-X

Syncade

PharmaSuite

Opcenter

VMware

ERP integration

Jobbeschreibung

ALTEN is seeking a skilled MES System Engineer to join our client's team, supporting maintenance, optimization, and continuous improvement of MES across manufacturing sites. You will ensure reliability, compliance, and efficiency of MES operations while collaborating with Automation, IT, Validation, Quality, and Manufacturing teams to drive digitalization and standardization.

The role emphasizes GMP-compliant electronic batch records, GxP documentation, and system lifecycle management, with a