Validation - CSV Support (Aibonito, PR)

Guaynabo , Puerto Rico
full-time

Provide support for the CSV lifecycle

This position will work with Computer System Validation (CSV), IQ, OQ, GAMP5 CSV and will be responsible for: 

  • Develop SDLC documents for Manufacturing Equipment including CSV executions and reports
  • Validation protects as required by client. 
  • The validation deliverables may include URS, FRA, DQ, pFMEA, Risk Assessments, Traceability Matrix, FAT, SAT, IOPQ, Media Fill, Cleaning Validation, Process Validation. 
  • Development of CSV System Impact and Risk Assessment as part of the requirements of combined Equipment and CSV Validation Plan.
  • Development of IOQ protocol and Summary Report 
  • Review and Tests script inclusion (CSV) to Installation and Operational Qualification.

 

BS Engineering, Sciences

3+ years of experience

Positions available for Puerto Rico.

Validation and Engineering Group, Inc is an Equal Employment Opportunity employer.

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