MES Engineer

About the Role:

We are seeking a skilled MES System Engineer to join our client's team and support the maintenance, optimization, and continuous improvement of their Manufacturing Execution Systems (MES). In this role, you will ensure the reliability, compliance, and efficiency of MES operations across our manufacturing sites, collaborating with cross-functional teams to drive digitalization and standardization.

Key Responsibilities:

• 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.

Qualifications & Experience:

• 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.