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JD: • A dynamic professional with proven expertise in Siemens Opcenter Medical Devices / Camstar application in Manufacturing Execution domain. • Design and architect multi-site MES Opcenter implementation based on discussion with business teams and their processes • Understand the paper Batch record and business process flow in collaboration with business SMEs • Expertise in high-performance, cross-functional teams developing, and supporting information systems in the Medical Device and pharmaceutical manufacturing industries • Data-driven, user-centric, technology, and information solutions business systems analyst with a deep understanding of business processes under GxP, ISO, and regulatory compliance Knowledge of Mfg. Process Controls and Reporting program • Awareness of Electronic Lot History Records using Camstar/OpCenter Software for Medical Device/ Pharma industries • Implement and execute the shopfloor transaction using OpCenter Execution Discrete in Discrete manufacturing Industry • Experienced in Camstar (V8.x) Modeling Configuration, Designer,OpCenter Connect MOM, OpCenter Connect cloud, Portal studio • Design and architect the interfaces and middleware data transfers with the OpCenter solution • Experience in C# and object oriented programming concepts • Author Computer System Validation (CSV) documents such as Functional Risk Assessment, Validation Plan, System Test Plan, Test Summary Reports (IQ/OQ/UAT), Validation Report, etc. following industry standard GAMS 5 and/or following the client Quality standards. Author and review test scripts (IQ, OQ, PQ) • Perform IQ (application and devices), OQ (including the Siemens CAMSTAR / OpCenter MES System integration with SAP, Client and other L3/L2 systems) • Assist Recipe Author / Modeler in Key user and end user training content creation based on the standard Siemens CAMSTAR / OpCenter MES System product training material • Assist CoE and Site in conducting End user training

Top Skills: Siemens Opcenter MES Manufacturing Consulting Medical Devices