EI&C MES System Engineer

• Key Responsibilities

• Maintain, govern, and continuously improve 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 according to 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 requirements.
• 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 and 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.

Qualifications & Experience

• Degree in Automation Engineering, Information Technology, Computer Science, Electrical Engineering, or a related technical discipline.
• Proven experience with MES, Manufacturing IT, OT, or automation systems within a GMP-regulated pharmaceutical, biotech, or life sciences environment.
• Strong understanding of manufacturing processes, batch execution, and electronic records management.
• Experience supporting system implementations, enhancements, upgrades, and operational support activities.
• Familiarity with GAMP, GMP, data integrity, and computerized system validation (CSV) practices.

Technical Skills

• IT/OT background with strong understanding of manufacturing system architectures.
• Experience with Manufacturing Execution Systems (e.g., PAS-X, Syncade, PharmaSuite, Opcenter, or similar platforms).
• Knowledge of OT infrastructure, industrial networking, virtualization technologies (VMware), and server environments.
• Understanding of system integration concepts and interfaces between MES, ERP, historians, and automation platforms.
• Knowledge of cybersecurity principles and best practices within manufacturing environments.
• Experience with GxP documentation and change management processes.

Languages

100% Site Based VISP