I am currently working with my client to assist them recruit for a CSV engineer who 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 from software install to business release
* Generate computer system validation documentation in accordance with site procedures and GMP guidelines
* Liaise with service providers to determine successful installation of instrument software and ensure correct configuration
* Execute test scripts, analyze test results and determine the acceptability of results against pre-determined criteria
* Work with the business to identify and implement procedural controls to mitigate issues found during testing
* Initiate and implement Change Control activities in accordance with Quality Standards and Practices
* Determine solutions or recommendations for changes and/or improvements
* Follow all relevant Environmental, Health and Safety procedures and assist in incident investigations as required
* Minimum 3-5 years' experience validating IT applications e.g. requirements gathering, design documentation, test case development, system & acceptance testing
* IT qualification would be an advantage but not required
* Past proven experience engaging business users to ensure that appropriate business needs are clearly defined, communicated and delivered at or above expectations
* Strong oral and written communication skills are required, with proven ability to communicate and build relationships cross-functionally
* Experience of server and workstation platforms and working in a Win 10 environment
* Experience of SQL databases is an advantage
* Experience of analyzing and challenging s/w to identify gaps.
* Familiar with Annex 11/21CFR Part 11 requirements, GAMP 5 and data integrity guidelines
* S/he is expected to be self-motivated and develop an understanding of the business.
* Self-Motivation, use initiative to identify and drive improvements
* Experience of working in a pharmaceutical API manufacturing operation or a regulated environment is desirable.
If this sounds like you then please email me at with your CV and we can arrange a call.