• 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, PAC 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