Validation - CSV Support (Aibonito, PR)

Validation & Engineering Group, Inc. is a leading services supplier who provides solutions for the Pharmaceutical, Biotechnology, Chemical, and Medical Devices industries in the following areas: Laboratory, Compliance, Computer, Engineering, Project Management, Validation, among other services. 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.