Job Summary :

We are looking for an experienced MES Consultant with strong expertise in Werum PAS-X to support manufacturing execution system implementations and digital transformation initiatives within regulated pharmaceutical and life sciences environments.

The ideal candidate should have hands-on experience in configuring, customizing, and implementing PAS-X solutions, with strong domain knowledge in electronic batch record management, manufacturing processes, compliance standards, and enterprise integrations.

Key Responsibilities :

- Implement, configure, and support Werum PAS-X MES solutions for pharmaceutical and life sciences manufacturing environments.

- Design, configure, and maintain Master Batch Records (MBR), Generic Master Batch Records (GMBR), Process Master Batch Records (PMBR), and Electronic Batch Records (EBR).

- Gather business and manufacturing requirements and translate them into MES functional and technical specifications.

- Configure workflows, recipes, materials management, equipment integration, and production execution processes in PAS-X.

- Ensure compliance with GxP, 21 CFR Part 11, GMP, and other regulatory standards.

- Support validation activities including IQ, OQ, PQ, CSV documentation, and audit readiness.

- Work with manufacturing, quality, validation, and IT teams to streamline production processes.

- Integrate MES with enterprise systems such as SAP ERP, LIMS, SCADA, and other shop-floor systems.

- Develop and support integrations using REST APIs, web services, middleware, and database connectivity.

- Troubleshoot MES issues, perform root cause analysis, and provide production support.

- Participate in solution design, deployment planning, testing, and go-live support.

- Prepare technical documentation, configuration documents, SOPs, and training materials.

Required Skills & Qualifications :

- 6+ years of experience in MES implementation and consulting.

- Strong hands-on experience in Werum PAS-X.

- Expertise in MBR, GMBR, PMBR, and EBR configuration and management.

- Strong knowledge of ISA-95 and ISA-88 standards.

- Good understanding of pharmaceutical manufacturing processes and shop-floor operations.

- Experience with GxP compliance, validation, and regulated environments.

- Hands-on experience with SAP-MES integration.

- Technical experience in Java or .NET development.

- Strong SQL/database skills for querying, troubleshooting, and data validation.

- Experience working with REST APIs, web services, and system integrations.

- Understanding of batch management, process execution, and manufacturing workflows