MES Engineer

Job Title: MES Engineer

Industry Focus: Pharmaceuticals, Life Sciences, Medical Devices, Biotech, High-Compliance Manufacturing

Role Overview:

The MES Engineer is responsible for the digital management of Manufacturing Execution Systems (MES) to ensure efficient and compliant manufacturing operations. This role focuses on MES configuration, electronic batch record (EBR) management, and integration with ERP and LIMS systems, while ensuring alignment with regulatory compliance standards such as GMP, 21 CFR Part 11, and GAMP 5.

Key Responsibilities:

Configure and maintain MES platforms such as Siemens Opcenter, Emerson Syncade, or Werum PAS-X.

Manage and design electronic batch records and related manufacturing documentation.

Integrate MES with upstream/downstream systems including ERP (SAP/Oracle) and LIMS.

Support digital transformation initiatives in manufacturing by improving data integrity, traceability, and automation.

Ensure compliance with regulatory standards (GMP, 21 CFR Part 11, GAMP 5) throughout system lifecycle and operations.

Required Skills & Technologies:

Strong hands-on experience with MES platforms: Siemens Opcenter, Emerson Syncade, or Werum PAS-X

Proficiency in SQL, scripting, and system integration

Experience with ERP systems (e.g., SAP, Oracle) and LIMS

Deep understanding of GMP, 21 CFR Part 11, and GAMP 5

Knowledge of ISA-95 standards and electronic batch record (EBR) best practices