Company Description

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.

Job Description

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.