- Around 10 - 14years of experience in computer system validation role in Pharma, Biopharmaceutical manufacturing environment.
- Facilities, utilities and equipment qualification. Unit operations automation qualification with DCS - honeywell/ DeltaV and PLC based systems, computerised system validation
- Well versed in control system validation for process control systems (PCS), Building management systems (BMS), Environmental monitoring systems (EMS).
- Developing automation validation master plan based on GAMP.
- Root cause analysis and Failure investigation
- Development of traceability matrices, GAP analysis and final report
- Understanding of PLC, SCADA, DCS, Honeywell,
- Testing, commissioning (FAT,SAT) of the control system
- Knowledge on Gamp5, S88, S95, E2500.
- BSc/BE/ BTech degree in Automation, Instrumentation and Control, Electronics, Biotechnology
- Must comply with cGMP requirements.
- Must possess good knowledge on clean rooms and classified area requirements.
- Willing to travel up to 50% or more within or outside India.
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