Validation - CSV Support (Aibonito, PR)
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.