MES Sepasoft

As an MES EBR Developer at Sepasoft, your role will involve designing, developing, and deploying Manufacturing Execution System (MES) solutions tailored for pharmaceutical manufacturing. You will work with Sepasoft MES, and optionally Werum PAS-X or Siemens Opcenter MES, ensuring seamless integration with third-party tools while following industry regulations. Key Responsibilities: - Configure master data such as materials, equipment, users, and work centers within the MES system. - Interpret pharmaceutical batch process requirements to design Electronic Batch Records (EBR), define workflows, and establish data input/output parameters. - Analyze customization requirements, design, and develop MES functionalities aligned with pharmaceutical manufacturing processes. - Design, simulate, and validate MES workflows and recipes before deployment. - Integrate MES with SAP and third-party software like Recipe Management Systems (RMS) and Laboratory Testing Devices (LIMS). - Understand MES architecture and define integration strategies with external systems. - Conduct troubleshooting, debugging, rework, and validation activities to ensure system reliability and compliance with regulatory requirements. Qualifications & Experience: - Bachelors 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; 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 like Batch Procedure, Business Connector, Web Services, Track & Trace, and Document Management. - Proficiency in 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.,