SME - MES & Manufacturing IT Operation

Responsibilities

• Act as the senior technical authority and SME for PAS-X MES across multiple manufacturing plants.
• Define MES architecture, integration standards, and technical governance for L2 systems.
• Lead end-to-end L2 integration architecture involving PLC, SCADA, and DCS systems.
• Own the validation strategy for MES and L2 systems, ensuring compliance with GAMP 5 and 21 CFR Part 11.
• Review and approve critical technical documentation including URS, FS, DS, CS, IQ, OQ, and PQ.
• Manage user access administration and perform periodic reviews for manufacturing applications.
• Support Quality Management System (QMS) activities, including deviations, investigations, and CAPA.
• Serve as the technical representative during internal, external, and regulatory audits.

Requirements

• Bachelor's Degree in Engineering (IT, Computer Science, Electronics, or Instrumentation) or Pharmaceutical Sciences.
• 10+ years of experience in MES implementation and support within pharmaceutical manufacturing.
• Deep hands-on expertise with Werum PAS-X MES architecture and configuration.
• Extensive experience with L2 integrations involving PLC, SCADA, and DCS systems.
• Proven expertise in Computer System Validation (CSV) and GxP compliance.
• Strong knowledge of 21 CFR Part 11, ALCOA+ principles, and GAMP 5.

Preferred Qualifications

• Master's Degree in Industrial Automation, Pharmaceutical Technology, or a related technical field.
• Certifications in MES platforms (e.g., Werum PAS-X, Siemens Opcenter, or Rockwell Pharma Suite).
• Advanced knowledge of ISA-95 and ISA-88 standards.

About the Company

Sun Pharmaceutical Industries Ltd is a leading global pharmaceutical company dedicated to providing high-quality medicines. We foster an environment where employees can grow, take charge of their journeys, and thrive within a supportive, collaborative community.