Title :SME - MES & Manufacturing IT Operation**:

- Date: May 8, 2026
- Location: Halol 1 - Information Technology
- Company: Sun Pharmaceutical Industries Ltd Areas Of Responsibility

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.

Are You Ready to Create Your Own Sunshine? 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 cooperative spirit, knowing that we ‘Thrive together’ and support each other’s journeys.” 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 systemsThe 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 environmentResponsibilities- 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.

MES & L2 Integration Leadership

- 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 EBR, parameters, and equipment status.

Interfaces with GMP & Utility Systems

- Technical owner for interfaces with BMS and EMS systems.
- Ensure data integrity, traceability, and audit readiness across interfaces.

PAS-X SME Responsibilities

- 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.

Validation & Compliance Leadership

- 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.

Manufacturing IT Application & User Management

- 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

User Support & Business Alignment

- 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.

Quality Management System (QMS) & Compliance

- 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.

Validation, Qualification & Regulatory Compliance

- Prepare, review, and maintain IT-related SOPs applicable to Manufacturing Automated Systems, including PCS Systems.

- Perform and participate in qualification and validation activities (IQ, OQ, PQ) for Manufacturing Automated Systems from IT administration roles.

- Review validation and qualification documentation from an IT perspective, covering:

- 21 CFR Part 11 applicability

- Electronic Records / Electronic Signatures (ER/ES)

- User and role management

- Software categorization

- Audit trails and data integrity

Backup, Security & Inventory Management

- 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.

Audit & Inspection Support

- Participate in internal, external, regulatory, and customer audits and respond to IT-related observations for Manufacturing Automated Systems and PCS Systems.
- Ensure all IT manufacturing systems remain audit-ready and compliant at all times.

Authorization & Governance

- Act as an authorized approver for IT-related manufacturing system documents, on behalf of the Section Head, wi

📌 Sme - Mes & Manufacturing IT Operation (Halol)
🏢 Sun Pharmaceutical Industries
📍 Halol