Manager- SME MES

Location:

Halol 1 - Information Technology

Company:
Sun Pharmaceutical Industries Ltd

Lead SME – MES

G10/G9B

Global IT

Manufacturing IT

Halol

At Sun Pharma, we commit to helping you “Create your own sunshine”— by fostering an environment where you grow at every step, take charge of your journey and thrive in a supportive community.

As you enter the Sun Pharma world, you’ll find yourself becoming ‘Better every day’ through continuous progress. Exhibit self-drive as you ‘Take charge’ and lead with confidence. Additionally, demonstrate a collaborative spirit, knowing that we ‘Thrive together’ and support each other’s journeys.

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.

• Practical experience in the implementation and technical support of pharmaceutical manufacturing applications such as eLogbook, IPQC, and similar systems.
• Strong background in working with pharma manufacturing equipment, including integration with central SCADA, DCS, and historian systems for data collection and monitoring.
• Ability to prepare URS for new equipment, with a focus on integration and connectivity requirements.
• Familiarity with automation protocols and data exchange standards to ensure smooth communication between equipment and enterprise systems.

Medium

• Global IT & MES Program Team – Aligning enterprise MES architecture and integration standards.
• QA & Compliance Teams – Ensuring validation and adherence to GxP, GAMP 5, and 21 CFR Part 11.
• Manufacturing Operations & Production Teams – Coordinating MES workflows, recipes, and shop‑floor integration.
• Engineering & Automation Teams – Managing L2 integrations with PLC, SCADA, and DCS systems.
• Site Leadership & Business Stakeholders – Providing updates on MES strategy, upgrades, and audit readiness.
• Validation & CSV Teams – Reviewing and approving URS, FS, DS, CS, IQ, OQ, PQ documentation.

• MES Vendors (e.g., Werum PAS‑X provider) – Collaborating on system upgrades, patches, and technical support.
• System Integrators – Reviewing and approving technical designs, integration strategies, and ensuring compliance with enterprise standards.
• Regulatory Auditors & Inspection Bodies – Acting as the technical representative during audits and inspections to demonstrate compliance with GxP, 21 CFR…