Senior Validation / CSV Engineer

An experienced and highly competent Validation Engineer. Holds a B Tech. in Production Management and an M Tech. in Computer Integrated Manufacturing. Experience includes computer system validation, laboratory equipment qualification and implementation of 21 CFR Part 11 compliant systems.

Experienced in implementation and management of quality systems and quality auditing. A qualified trainer and has worked as computer system trainer also.

Skills and Experience:

• Computer system validation
• Laboratory Equipment Qualification
• Temperature Mapping
• Implementation of 21 CFR Part 11 and Annex 11 Compliant computerised systems
• Spreadsheet validation
• Validation of calibration systems including CompuCal, SCADA and Delta V
• Training – IT and Validation
• Implementation and management of quality systems
• GAMP5 qualification