Computer System Validation - Lead [J-54]

Computer System Validation - Lead [J-54]

12 Jun
Recognized company

12 Jun

Recognized company


- 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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- html


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