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MES Specialist

Patel Consultants Corp

This is a Full-time position in Summit, NJ posted June 7, 2021.

PURPOSE AND SCOPE OF POSITION The Sr. Specialist, Process Technology is responsible for the solution design, on-site technical support, troubleshooting and problem resolution, recipe development and change management for the site Syncade Manufacturing Execution System (MES) and Enterprise Resource Planning (ERP) system. Specialists work with IT, manufacturing, engineering, vendors, and resources supporting boundary systems to deliver changes to MES recipes. The position requires strong project management skills and coordination with stakeholders. REQUIRED COMPETENCIES bull Advanced proficiency in Microsoft Excel Visio bull Advanced knowledge of Manufacturing Execution Systems and ERP systems bull Intermediate knowledge of qualification and validation requirements in a regulated environment bull Intermediate knowledge of GMP manufacturing bull Intermediate technical writing skills Education and Experience bull Bachelorrsquos degree in a related field from an accredited college or university required. bull Minimum of 5 years relevant work experience required, preferably in a pharmaceutical manufacturing environment. DUTIES AND RESPONSIBILITIES bull Responsible for providing Manufacturing Execution System operational support, documentation, recipe development, and change management. bull Maintain MES library of objects and recipes utilized in manufacturing. bull Works with site functional teams, including manufacturing, engineering, warehouse and quality assurance to gather user requirements for recipe development. bull Convert user requirements and paper Master Batch Records (MBRs) into MES electronic batch record (EBR) recipes. bull Develop documentation to support the qualification of the MES recipes, including test scripts and functional specifications. bull Execute testing of the recipes in the development environment to ensure functionality. bull Manage User Acceptance Testing process for recipe qualification. bull Develop and deliver reports from reporting software. bull Adhere to GxP regulatory requirements and internal procedures. bull Provide technical support by troubleshooting and resolving MES and ERP issues to support manufacturing operations.