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.

Qualifications

BS Engineering, Sciences

3+ years of experience

Additional Information

Positions available for Puerto Rico.

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