Title:  SME - MES & Manufacturing IT Operation

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 collaborative 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 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

Responsibilities

• 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

• Handle and execute IT-related QMS documents in TrackWise 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.

Validation, Qualification & Regulatory Compliance

1. Prepare, review, and maintain IT-related SOPs applicable to Manufacturing Automated Systems, including PCS Systems.
2. Perform and participate in qualification and validation activities (IQ, OQ, PQ) for Manufacturing Automated Systems from IT administration roles.
3. 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

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

Authorization & Governance

1. Act as an authorized approver for IT-related manufacturing system documents, on behalf of the Section Head, within defined authorization limits.

Travel Estimate

Medium

Job Scope

Internal Interactions (within the organisation)

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.

External Interactions (outside the organisation)

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 Part 11, and data integrity requirements.

Third-party Automation Partners – Coordinating L2 system integrations (PLC, SCADA, DCS) and validation activities.

External Consultants – Engaging for specialised MES architecture, validation strategy, and compliance expertise when required.

Validation Service Providers – Collaborating on outsourced validation documentation and execution (URS, FRS, IQ, OQ, PQ)

Geographical Scope

India and global sites

Financial Accountability (cost/revenue with exclusive authority)

No direct financial authority

Job Requirements

Educational Qualification

Bachelor’s Degree in Engineering (Information Technology, Computer Science, Electronics, Instrumentation) or Pharmaceutical Sciences.

Preferred: Master’s Degree (e.g., MTech, MBA, M. Pharm) with specialization in Industrial Automation, Pharmaceutical Technology, or related technical fields.

Specific Certification

GAMP 5 - For system validation in regulated environments.

CSV (Computer System Validation) - Ensuring compliance with GxP requirements.

MES Platform Certifications – e.g., Werum PAS-X, Siemens Opcenter, Rockwell Pharma Suite.

21 CFR Part 11 Compliance Training – For electronic records and signatures.

ISA-95 / ISA-88 Standards Knowledge – For MES and automation integration.

Data Integrity & ALCOA+ Principles Training – Ensuring audit readiness and compliance.

Experience

10+ years of experience in MES implementation and support within pharmaceutical manufacturing environments.

Deep hands-on expertise with Werum PAS-X MES, including architecture, configuration, and master data governance.

Extensive L2 integration experience with PLC, SCADA, and DCS systems for shop-floor automation.

Proven track record of owning validated GMP systems and ensuring compliance with GAMP 5, 21 CFR Part 11, and ALCOA+ principles.

Leadership in technical governance for MES upgrades, patches, and performance optimization.

Audit readiness and representation during regulatory inspections and internal audits.

Strong validation experience, including URS, FRS, DDS, IQ, OQ, and PQ documentation and execution.

Functional Skills:

MES System Architecture & Configuration (Werum PAS-X expertise).

L2 Integration with PLC, SCADA, and DCS systems.

Validation Protocol Development & Execution (URS, FRS, DDS, IQ, OQ, PQ).

Gxp Compliance and Computer System Validation (CSV).

Data Integrity and Audit Readiness (21 CFR Part 11, ALCOA+ principles).

Master Data Governance, Recipe Management, and Workflow Design.

Troubleshooting MES performance and integration issues.

Technical Governance for MES upgrades and patches.

Behavioural Skills:

Strong Communication and Stakeholder Management.

Leadership in cross-functional teams and decision-making.

High Attention to Detail and Compliance Mindset.

Proactive Problem-Solving and Risk Management.

Ability to Work Under Pressure and Manage Multiple Priorities.

Collaborative and Influential in Global IT and Manufacturing environments.

Your Success Matters to Us

At Sun Pharma, your success and well-being are our top priorities! We provide robust benefits and opportunities to foster personal and professional growth. Join us at Sun Pharma, where every day is an opportunity to grow, collaborate, and make a lasting impact. Let’s create a brighter future together!