MES Site SME Lead – Manufacturing IT

Sun Pharmaceutical Industries, Inc.; Indiana; On-site; USD 13,000 - 19,000; Full time

Job summary

Sun Pharma seeks a seasoned Site SME – MES Project to lead MES design, configuration, and deployment across Halol and Baska sites. You will drive validation (IQ/OQ/PQ/UAT), ensure GxP compliance, and own all related documentation while supporting end-users post go-live.

You’ll collaborate with global MES teams, QA IT, and shop-floor staff to align processes with global standards, manage data migration, and deliver training. Experience with Werum PAS-X is highly preferred.

Qualifications

• Bachelor’s degree in Engineering or related technical field.
• Master’s degree with specialization in Industrial Automation or Pharmaceutical Tech.
• GAMP 5 and CSV for GxP/compliance.
• MES platform certifications (Werum PAS-X, Siemens Opcenter).
• 21 CFR Part 11 compliance training as a plus.

Responsibilities

• Represent site MES design, configuration, and deployment.
• Lead IQ/OQ/PQ/UAT validation and traceability.
• Manage GxP documentation (URS, FS, DS, test cases).
• Maintain MES knowledge, provide front-end user support.
• Deliver training and drive user readiness for MES usage.
• Coordinate data migration and master recipe creation.
• Ensure audit readiness and regulatory compliance.

Skills

MES

L2 systems

Validation

GxP

Documentation

Front-End Support

Training

Data Management

Audit readiness

Education

Bachelor's degree in Engineering

Master’s degree (MBA / M.Tech / M.Pharm)

GAMP 5, CSV, 21 CFR Part 11

Tools

Werum PAS-X

Siemens Opcenter

Rockwell

SAP MES integration

Job description

Sun Pharma seeks a seasoned Site SME – MES Project to lead MES design, configuration, and deployment across Halol and Baska sites. You will drive validation (IQ/OQ/PQ/UAT), ensure GxP compliance, and own all related documentation while supporting end-users post go-live.

You’ll collaborate with global MES teams, QA IT, and shop-floor staff to align processes with global standards, manage data migration, and deliver training. Experience with Werum PAS-X is highly preferred.