MES Specialist - Drug Product/ Sterile Operations

The MES Specialist is responsible for the implementation, configuration, maintenance, and support of Manufacturing Execution Systems (MES) to enable compliant, efficient, and paperless manufacturing operations. The role ensures seamless integration between shop‑floor equipment, SAP systems, and quality systems while maintaining data integrity, regulatory compliance, and operational excellence in a GMP environment.

• To Work in shift operation as per production schedule.
• Responsible to configure, deploy, and support MES applications.
• Create and maintain Electronic Batch Records (EBR), master recipes, workflows, and system parameters.
• Perform MES change management including configuration changes, upgrades, and patch installations.
• Ensure MES compliance with GxP, 21 CFR Part 11, EU Annex 11, and ALCOA+ principles.
• Support CSV activities including URS, FRS, DS, IQ, OQ, PQ, and risk assessments.
• Partic...