4.0 - 8.0 years

0 Lacs

pune, maharashtra

On-site

As an MES EBR Developer at Sepasoft, you will be instrumental in the design, development, and deployment of Manufacturing Execution System (MES) solutions tailored for pharmaceutical manufacturing. Your responsibilities will encompass configuring master data, interpreting batch process requirements for Electronic Batch Records (EBR), customizing MES functionalities, and ensuring seamless integration with third-party tools while complying with industry regulations. Your role will involve configuring master data such as materials, equipment, users, and work centers within the MES system. You will interpret pharmaceutical batch process requirements to design Electronic Batch Records (EBR), define workflows, and establish data input/output parameters. Furthermore, you will analyze customization requirements, design, and develop MES functionalities to align with pharmaceutical manufacturing processes. In addition, you will design, simulate, and validate MES workflows and recipes before deployment. Experience in integrating MES with SAP and other third-party software such as Recipe Management Systems (RMS) and Laboratory Testing Devices (LIMS) will be crucial. You should be adept at understanding MES architecture and defining integration strategies with external systems. Troubleshooting, debugging, rework, and validation activities will be part of your routine tasks to ensure system reliability and compliance with regulatory requirements. The ideal candidate will hold a Bachelor's degree in Computer Science, Information Technology, or Electrical & Electronics Engineering, coupled with at least 4 years of hands-on experience in Sepasoft MES development, particularly in Electronic Batch Records (EBR) projects. A strong understanding of MES architecture and deployment strategies is essential, along with experience in Sepasoft MES. Familiarity with Werum PAS-X and Siemens Opcenter MES is advantageous. Proficiency in pharmaceutical manufacturing processes and regulatory compliance standards such as GMP, FDA 21 CFR Part 11, and validation protocols is necessary. Preferred skills include hands-on experience with Sepasoft MES modules like Batch Procedure, Business Connector, Web Services, Track & Trace, and Document Management. Additionally, expertise in Python, Microsoft SQL Server, MES integration with Recipe Management Systems (RMS) and LIMS, and familiarity with ISA-95 standards for MES implementation will be beneficial. Strong troubleshooting and problem-solving skills are also highly valued in this role.,

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Production Manager PRAVAIG DYNAMICS PRIVATE LIMITED

5.0 - 9.0 years

0 Lacs

karnataka

On-site

As the Head of Production, you will play a crucial role in the planning, coordination, and control of manufacturing processes, focusing on Factory Layout and Production Layout. Your responsibilities will include collaborating with internal and external stakeholders to provide technical support, ensuring the production of top-notch products and adherence to best business practices. You will lead and manage teams and projects across the organization, offering clear direction, inspiration, and guidance to drive excellence and motivate staff towards success. Your primary responsibilities will involve designing and validating factory layout and production layout, developing engineering bills of process and resources, and planning manufacturing processes for assembly. You will be tasked with conducting capacity and cycle time calculations, as well as planning and designing equipment, tooling, jigs, and fixtures. Additionally, you will be involved in supplier qualification processes, developing quality metrics, and performing various analyses to ensure optimal performance and efficiency. Furthermore, you will be responsible for planning and executing MES architecture in line with ISA95 standards and implementing Industry 4.0 strategies. Managing factory operations, ensuring compliance with regulatory requirements, conducting safety and risk analyses, and implementing ISO standards will also be part of your role. To excel in this position, you should hold a BE/ME degree in Mechanical, Automobile, or Industrial Engineering, with a strong background in Factory and Layout planning. Experience in automated and manual assembly lines, tool design, manufacturing processes, and knowledge of quality standards are essential. Familiarity with GD&T, tolerance stack-up analysis, APQP, DFMEA, PFMEA, as well as PLM, ERP, and ISO standards is required. Knowledge of CMM, Blue light scanning, and I4.0 principles will be advantageous. Key competencies for success in this role include being results-oriented, self-motivated, and possessing a problem-solving attitude. Integrity, teamwork, and a sense of ownership are critical traits for this position, as is a commitment to driving performance and contributing to the organization's success.,

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