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Computer System Validation Lead

10.00 to 14.00 Years   Hyderabad   29 May, 2020
Hyde Engineering and Consulting India Pvt Ltd
Job LocationHyderabad
EducationNot Mentioned
SalaryNot Disclosed
IndustryOil & Gas / Petroleum
Functional AreaGeneral / Other Software
EmploymentTypeFull-time

Job Description

  • 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, Rockwell
  • 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.
Supported File Formats
  • html
,

Keyskills :
rootcauseanalysis computersystemvalidation buildingmanagementsystems continuousimprovementfacilitation rootcause cleanrooms gapanalysis controlsystem processcontrol unitoperations managementsystems buildingmanagement environmentalmonitoring

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