15h Left MES – Sepasoft, Location Bangalore

2 weeks ago

Pune, Maharashtra, India Capgemini Engineering Full time
MES Developer – Sepasoft

Job Overview:

The MES EBR Developer will play a key role in designing, developing, and deploying Manufacturing Execution System (MES) solutions for pharmaceutical manufacturing.

The role involves working with Sepasoft MES and optionally Werum PAS-X or Siemens Opcenter MES, ensuring seamless integration with third-party tools while maintaining compliance with industry regulations.

Key Responsibilities:

• Master Data Configuration: Configure master data such as materials, equipment, users, and work centers within the MES system.

• Electronic Recipe Management: Interpret pharmaceutical batch process requirements to design Electronic Batch Records (EBR), define workflows, and establish data input/output parameters.

• Customization & Development: Analyze customization requirements, design, and develop MES functionalities to align with pharmaceutical manufacturing processes.

• Simulation & Testing: Design, simulate, and validate MES workflows and recipes before deployment.

• Experience in integrating MES with SAP and third party softwares such as Recipe Management Systems (RMS) and Laboratory Testing Devices (LIMS).

• Ability to understand MES architecture and define integration strategies with external systems.

• Troubleshooting & Validation: Conduct troubleshooting, debugging, rework, and validation activities to ensure system reliability and compliance with regulatory requirements.

Qualifications & Experience:

• Bachelor's degree in Computer Science, Information Technology, Electrical & Electronics Engineering.

• 4+ years of hands-on experience in Sepasoft MES development, particularly in Electronic Batch Records (EBR) projects.

• Strong understanding of MES architecture and deployment strategies.

• Experience with Sepasoft MES is required; familiarity with Werum PAS-X and Siemens Opcenter MES is a plus.

• Strong understanding of pharmaceutical manufacturing processes and regulatory compliance (GMP, FDA 21 CFR Part 11, and validation protocols).

Preferred Skills:

• Hands-on experience with Sepasoft MES modules, including Batch Procedure, Business Connector, Web Services, Track & Trace and Document Management.

• Hands-on experience with Python, Microsoft SQL Server.

• Experience in MES integration with Recipe Management Systems (RMS) and LIMS.

• Familiarity with ISA-95 standards for MES implementation.

• Excellent troubleshooting and problem-solving skills

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