Job Description

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 for the testing of the application and Line controller.
• Review and Tests script inclusion (CSV) to Installation and Operational Qualification.

Qualifications

• Bachelor's or Master's Degree in Engineering, Computer Science, or related discipline.
• At least (4) to (10) years of experience in validation of computerized systems (CSV) in pharmaceutical products or manufacturing environment 
• Knowledge on computerized systems with data collection software (database), network communications protocol, GAMP5 methodology for validation and cGMPs regulations.
• Good skills writing general documentation in English and using MS Office applications.
• Experience with Manufacturing processes.

Additional Information

Positions available for Puerto Rico.

VALIDATION AND ENGINEERING GROUP, INC IS AN EQUAL EMPLOYMENT OPPORTUNITY EMPLOYER.