MES Site SME Lead - Pharma Manufacturing

Sun Pharmaceutical Industries Ltd; United States; In loco; USD 90.000 - 150.000; Tempo pieno

Descrizione del lavoro

Sun Pharma is seeking a Site SME – MES Project with 6–8 years in pharma and hands-on MES/L2 experience. The role ensures site MES alignment with global standards, leads validation, and acts as the primary MES expert for Halol and Baska sites.

The candidate will manage documentation, provide end-user support, and drive training and adoption while ensuring compliance with FDA 21 CFR Part 11, EU GMP, and GAMP5.

Competenze

• Bachelor’s degree in Engineering or IT, or related field.
• Master’s degree preferred in Industrial Automation or Pharma tech.
• GAMP 5 and CSV experience for validation in regulated environments.
• Experience with MES platforms (Werum PAS-X) is a strong plus.
• Strong pharma manufacturing and GxP compliance background.

Mansioni

• Represent site needs during MES design, config, and deployment.
• Lead IQ/OQ/PQ/UAT validation and traceability activities.
• Own GxP documentation: URS/FS/DS and test plans.
• Maintain MES product expertise and support front-end issues.
• Deliver training and ensure user readiness for MES usage.
• Support data migration and master recipe creation.
• Ensure audit readiness and regulatory compliance.

Conoscenze

MES configuration

Validation

GxP compliance

Front-end support

Data migration

Communication

Formazione

Bachelor's degree in Engineering/IT

Master's degree preferred

Strumenti

Werum PAS-X

Siemens Opcenter

Rockwell

Descrizione del lavoro

Sun Pharma is seeking a Site SME – MES Project with 6–8 years in pharma and hands-on MES/L2 experience. The role ensures site MES alignment with global standards, leads validation, and acts as the primary MES expert for Halol and Baska sites.

The candidate will manage documentation, provide end-user support, and drive training and adoption while ensuring compliance with FDA 21 CFR Part 11, EU GMP, and GAMP5.