Our client is seeking an experienced and enthusiastic Computer System Validation Engineer to join their growing CSV team.
You will provide IT systems validation and compliance expertise for newly purchased instruments and support of existing instruments as well as maintaining all Lab based Systems on-site.
* Manage Computer System Validation projects
* Generate computer system validation documentation
* Liaise with service providers to determine successful installation of instrument software
* Execute test scripts and analyze test results
* Initiate and implement Change Control activities
* Minimum 3 years' experience validating IT applications
* Pharmaceutical background
* Experience of server and workstation platforms and working in a Win 10 environment
* Experience of analyzing and challenging s/w to identify gaps.
* Familiarity with Annex 11/21CFR Part 11 requirements, GAMP 5 and data integrity guidelines