MES Co-ordinator

Job Summary

We are seeking a seasoned professional with 6-8 years of experience in the pharmaceutical industry, including technical and functional experience in MES & L2 systems. The Site SME – MES Project is a key functional and technical expert responsible for supporting the successful implementation of the Manufacturing Execution System (MES) & L2 at the Halol & Baska pharmaceutical manufacturing sites. This role ensures that site-specific manufacturing processes are accurately captured and reflected in the global MES solution.

The SME is also accountable for leading site-level validation activities, technical owner responsibility and managing all GxP documentation related to the MES & L2 system. The Site SME is the go‑to authority for end‑to‑end MES product knowledge, including deep understanding of system functionality, configuration and compliance requirements. The SME also serves as the first point of contact for any MES front‑end application issues, supporting users in troubleshooting, training and ongoing system usage post go‑live.

The ideal candidate will ensure adherence to global regulations (FDA 21 CFR Part 11, EU GMP, GAMP5).

Previous experience with Werum (Korber Pharma) for pharma industry is a big plus.

• MES Implementation: Representing site‑specific needs during MES design, configuration and deployment.
• Validation Leadership: Leading IQ, OQ, PQ, UAT, and traceability matrix execution.
• Documentation Ownership: Managing GxP documentation (URS, FS, DS, test cases, validation plans/reports).
• MES Product Expertise: Maintaining deep knowledge of MES functionality and architecture.
• Front‑End Support: Acting as the first point of contact for MES application issues and user support.
• Training & Adoption: Delivering training and ensuring user readiness for MES usage.
• Data Management: Supporting data collection, migration and master recipe creation.
• Audit Readiness: Ensuring all documentation and systems are compliant and audit‑ready.

• Global MES Program Team – Collaborating to align site processes with global standards and system templates.
• Quality Assurance (QA) & QA IT – Ensuring validation and compliance with GxP and CSV standards.
• Business Users – Engaging with production, quality and operations teams for requirements gathering and support.
• Engineering & IT Teams – Coordinating technical aspects of MES deployment and integration.
• Site Leadership – Providing updates on MES implementation, validation status and issue resolution.
• End Users – Supporting MES usage, troubleshooting front‑end issues and providing training.

• MES Vendors & Consultants – Participating in workshops, configuration sessions and demos; resolving technical issues.
• Auditors & Regulatory Bodies – Supporting audits by ensuring system and documentation compliance.
• Third‑Party Validation Experts – Collaborating on validation strategy and execution if outsourced.
• External Support Teams – Engaging with vendor support for MES application troubleshooting and escalations.

Primary Sites:
Halol and Baska manufacturing sites.

Cost/revenue with exclusive authority.

Bachelor’s degree in Engineering – Information Technology, Computer Science, Production, Pharmaceutical Sciences or a related technical field.

Master’s degree (e.g., MBA, M.Tech, M.Pharm) with specialization in Industrial Automation, Pharmaceutical Technology or related technical fields.

• GAMP 5 – for system validation in regulated environments.
• CSV (Computer System Validation) – for compliance with GxP.
• MES Platform Certifications – e.g., Werum PAS‑X, Siemens Opcenter, or Rockwell.
• 21 CFR Part 11 Compliance Training – for electronic records and signatures.

• Pharmaceutical Manufacturing – Strong understanding of pharma shop floor operations and regulatory requirements.
• MES or Digital Systems – Prior hands‑on experience with MES platforms or similar systems in GxP‑regulated environments.
• Validation Expertise – Proven experience in validation documentation and execution, especially for GxP Category 4 & 5…