SME - MES & Manufacturing IT Operation

Job Summary

We are seeking a seasoned professional with 10+ years of experience in the pharmaceutical industry, including technical and functional expertise in MES, L2 and other manufacturing systems.

The Senior SME will act as the enterprise-level technical authority for MES and Level 2 integrations across pharmaceutical manufacturing sites. This role owns architecture, standards, integration strategy, validation approach, and technical governance for PAS-X MES and all connected shop‑floor and utility systems in a GMP-regulated environment.

Act as senior technical SME and technical authority for PAS-X MES across plants.

Define MES architecture, integration standards, and best practices.

Own technical decisions for MES & L2 upgrades, enhancements, and performance.

Act as an escalation point for complex MES issues and audit‑critical scenarios.

Own end‑to‑end L2 integration architecture.

Lead integrations with PLC, SCADA, and DCS systems.

Integrate balances, dispensing systems, and in‑process instruments.

Ensure validated data exchange for E , parameters, and equipment status.

Technical owner for interfaces with BMS and EMS systems.

Ensure data integrity, traceability, and audit readiness across interfaces.

Deep expertise in PAS‑X architecture and configuration.

Govern master data, workflows, recipes, and reporting.

Review and approve integrator technical designs.

Lead PAS‑X upgrade and patch assessments.

Own validation strategy for MES and L2 systems.

Review and approve URS, FS, DS, CS, IQ, OQ, PQ.

Ensure compliance with GAMP 5, 21 CFR Part 11, and ALCOA+.

Act as technical representative during audits and inspections.

• Manage user access administration and perform periodic access reviews for Manufacturing Applications in compliance with site SOPs and regulatory requirements.
• Provide administrative support for PCS Systems, including:
• User account creation and management
• Date and time synchronization
• System and security configuration
• Data backup and restoration support

• Understand manufacturing user requirements and coordinate with software / technical teams to finalize and implement solutions.
• Support end users by enabling scheduler reports and system outputs to streamline daily manufacturing activities and ensure system usability.
• Act as the single point of contact for IT‑related manufacturing system support at the site.

• Handle and execute IT‑related QMS documents in Track Wise or equivalent QMS applications.
• Participate in and execute QMS activities, including:
• Deviations
• Investigations
• CAPA related to Manufacturing Applications
• Support QMS investigations for Manufacturing and PCS systems from an IT perspective.

• Execute data backup and retrieval activities for Manufacturing Automated Systems and PCS Systems as per applicable SOPs.
• Maintain and periodically update the inventory list of Manufacturing Automated Systems, including associated IT infrastructure installed at the site.