MES System Engineer (EI&C)

Drive Operational Excellence in a Leading Manufacturing Environment

Join a dynamic team where your expertise in Manufacturing Execution Systems (MES) directly supports compliance, efficiency, and operational excellence. In this role, you will play a key part in maintaining and improving MES standards, supporting system operations, and ensuring strict adherence to regulatory requirements. This is a significant opportunity to contribute to the digitalization and optimization of manufacturing processes within a high-standard environment.

Core Responsibilities

• 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.

Key Skills and Requirements

• 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.
• Experience with MES platforms such as PAS-X, Syncade, PharmaSuite, Opcenter, or similar systems.
• Knowledge of OT infrastructure, industrial networking, virtualization technologies (e.g., VMware), and server environments.
• Understanding of system integration concepts between MES, ERP, historians, and automation platforms.
• Awareness of cybersecurity principles and best practices in manufacturing environments.
• Proficiency in GxP documentation and change management processes.
• Fluency in English and/or German.