MES Engineer (m/f/d)

Job Description

We are seeking a highly skilled MES (Manufacturing Execution System) Engineer to join our team. The ideal candidate will have strong experience in pharmaceutical manufacturing environments and a deep understanding of GxP compliance. This role involves designing, implementing, and supporting MES solutions to optimize production processes, ensure regulatory compliance, and enhance operational efficiency.

Key Responsibilities

• Design and Configure MES Solutions: Develop and implement MES functionalities to support batch execution, electronic batch records (EBR), and production workflows.
• System Integration: Collaborate with automation, ERP, and IT teams to integrate MES with other systems (e.g., SAP, LIMS, SCADA).
• Compliance & Validation: Ensure MES systems comply with GxP, FDA 21 CFR Part 11, and other regulatory requirements. Prepare and execute validation protocols (IQ/OQ/PQ).
• Troubleshooting & Support: Provide technical support for MES applications, resolve issues, and maintain system reliability.
• Continuous Improvement: Identify opportunities to enhance MES performance and streamline manufacturing processes.
• Documentation: Maintain accurate system documentation, SOPs, and change control records.

Additional Information

• Education: Bachelor’s degree in Engineering, Computer Science, or related field.
• Experience: Minimum 3–5 years working with MES systems (e.g., Koerber PAS-X, Rockwell Syncade, or similar). Must have Koerber PAS-X experience. Knowledge of Rockwell Pharmasuite, Siemens Opcenter & Emerson Syncade is an advantage. Strong background in pharmaceutical manufacturing and GxP compliance. Experience with system validation and regulatory audits.
• Technical Skills: Knowledge of SQL, scripting, and system configuration. Familiarity with integration to ERP and automation systems.
• Preferred: Experience with electronic batch records (EBR) implementation. Understanding of ISA-95 and ISA-88 standards. Previous involvement in MES deployment projects in regulated environments.