Minimum 4 years of experience

Experience in IT Validation, cGMP and 21CFR11 in an FDA regulated environment
Responsible for creation all validation documentation
Assist in the documentation of system requirements per business process definition
Execution of validation testing processes following good documentation practices
Experience working on multiple/concurrent projects
Have knowledge of validation principles including system development lifecycle methodology
Operation in lean and agile IT development practices, incorporating risk based approach
Experience working in team based collaborative setting
Interaction with IT Technical resources, Business Process representatives and Quality Operations colleagues

Provide validation support for Client's-IT Core Solutions creation and deployment at client locations.

Expertise in applications
Microsoft Office Suite – Word, Excel, Visio, etc.
Documentum – Document Management System
Trackwise – for Change Management System
GMP or other regulatory environment