Sudhakar Gundeti

WORK HISTORY

EDUCATION

ABOUT SUDHAKAR GUNDETI

I have 13 years of experience in the pharmaceutical industries (Injectables & OSD) as an Instrumentation Engineer.Responsible for Process Equipment Maintenance and Projects, Instruments Calibration and Preventive Maintenance.• Responsible for Process Instrumentation and Automation Projects, planning and execution of Projects.• Responsible for PLC, HMI, and SCADA Breakdowns and Computer system validation.• Equipment/Instrument Mapping in SAP for Calibration, Preventive Maintenance and Breakdown Maintenance.• Handled Greenfield project Execution of IBMS and EMS Projects.• Responsible for computer system validations (CSV) and GXP assessment of all Engineering & Process Equipment.• Responsible for day-to-day review on Breakdown and tracking CAPA and related action plans.• Hands on Experience on Honeywell servers of Environmental Monitoring System (EMS) & Integrated Management System.• To Ensure that Current Good Manufacturing Practices (CGMP) are being adhere to, during the Maintenance of Process equipment.• Preparation & Review of risk assessment & GAP Analysis of all Engineering & Process Equipment.• Initiation of Capex• Preparation of Drawing Layouts in AutoCAD.• Initiation of Digitization Projects (Predictive Maintenance, Track and Trace, L2 Integration-EBMR(OPC).• Familiar with FDA 21 CFR Part 11 and 820 Medical Device Manufacturing, or ISO 13485.• Hands on experience for PLC, SCADA & HMI, Mechanical Liner Cams, Servo Drives, Encoder and Vision system (Camera for Inspections.)• Responsible for Audit readiness for Global Audits, Internal Audits and Self inspections• Handling of Change control systems and Incident Management Systems through SAP.• Handling of QMS events through Track wise, SAP & preparation of Calibration and PM Planner in SAP.Projects Handled:• Medical Devices (Autoinjector and Pre-Filled Pen) & HH Packaging Line• EMS - L2 Integration projects (Rockwell, Delta V Syncade)• Predictive Maintenance for Process Equipment (Industry 4.0)• IBMS Projects-Central Control Room SCADA • Process Equipment (PLC/HMI/IPC and SCADA) Up gradation• Equipment Integration with Delta V and MES (OPC Tags integration, Historian & SCADA)• WIP system installation for Automated duct cleaning • CIP system for IPC BIN washing machine• Handled SAP, Trackwise, D2 & eValgenesisCertification: Industrial Automation & Industrial SafetyInterested Areas:• Device Projects (Pen, Autoinjector Assembly and Packaging Line).• Digitalization Projects (Industry 4.0, L2 integration and MES/eBMR).