MES Engineer

4 weeks ago

Bengaluru, India Capgemini Full time

About The Role  

We are seeking a skilled and experienced MES Engineer with hands-on expertise inKrber Werum PAS-Xto support manufacturing operations in a regulated pharmaceutical or life sciences environment. The ideal candidate will have a strong technical foundation, validation knowledge, and excellent communication skills to effectively bridge the gap between technical teams and business stakeholders.

Key Responsibilities:- 
- MBR Design & Development:
- Design and create complex Master Batch Records (MBRs) for Weighing & Dispensing, Manufacturing, and Packaging processes.
- Analyze site-specific requirements and translate them into functional MBRs.
- Validate MBRs for deployment across manufacturing sites.

System Configuration & Administration: 
- Configure and customize Werum PAS-X modules including GMBRs, PVL, PMBRs, Equipment Management, Material Flow, Weigh & Dispense, EBR, and Master Data.
- Design and developState Diagramsand determine updates forMaster DataandEquipment Management.

Integration & Interface Management: 
- Work on SAP-MES interfaces, Level 2 (L2) integrations, and report development.
- Ensure seamless data flow and system interoperability.

Compliance & Validation: 
- Ensure compliance with GxP, GAMP, and 21 CFR Part 11 standards.
- Participate in validation activities includingIQ/OQ/PQand documentation.

Project & Stakeholder Management: 
- Act as an Offshore Lead and manage service delivery for PAS-X.
- Liaise with clients and stakeholders to gather requirements and provide technical solutions.
- Provide support forWerum PAS-X installation, upgrade, development, and configuration.

Primary Skills (Must-Have): 
- Strong hands-on experience withWerum PAS-X(Specification, Execution, Compliance & Performance Modules).
- Expertise inMBR creation,State Diagram design, andMaster Data configuration.
- Experience inPAS-X System Administrationandcustomization.
- Knowledge ofISA-95/S88 standardsand their application in MES design.
- Familiarity withSAP-MES integrationandL2 automation systems.
- Understanding ofpharmaceutical manufacturing processesand regulatory requirements.

Secondary Skills (Good-to-Have): 
- Programming knowledge inSQL,C#, andJava.
- Experience withuser management,system profile creation, andreporting tools.
- Exposure toITIL frameworksandIT service management.
- Experience inproject management,client communication, andteam leadership.

ITSkills:
- SQL Queries
- C# (C-Sharp)
- Java

Experience in: 
- User management
- System profile creation
- System configuration and troubleshooting

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