CSV Engineer / Systems Validation Engineer (COR2298)

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Date PostedNovember 26CategoryOtherJob TypePermanentContact NameGraham BruceContact Number01865 784336LocationDidcot, OxfordshireSalary50,000BenefitsBack To Job BoardDescriptionCSV Engineer / Systems Validation Engineer
Are you an experienced CSV Engineer / Systems Validation Engineer, on the lookout for a technical challenge? Want to take ownership of an area, which long-term will be rolled out on a global scale?
This is a newly-created position within a highly-successful SME company, during a period of growth and transformation as a result of a recent acquisition.
The Role
The company, a leader in pharmaceutical services, is in need of a CSV Engineer / Systems Validation Engineer to assist in the design and roll out of a new IT Quality Framework. The CSV Engineer / Systems Validation Engineer will take responsibility for the documentation, maintenance and continued support of the framework, as well as ensuring compliance.
As well as validating scientific software and systems (including ERP), The CSV Engineer / Systems Validation Engineer, will be required to apply their previous experience of IT Quality and software/systems Validation to the IT infrastructure that underpins those systems, including:
Networking (circa 40 switches)
Active Directory
Virtualised servers (more than 10 hosts)
So whats required?
My client is keen to find a Systems Validation Engineer with skills/experience in as many of the following areas as possible. Due to their working within a highly-regulated environment and industry, any experience gained within a similarly regulated environment would be looked upon favourably:
Experience of IT Quality and validation
Knowledge of CSV validation strategies and GAMP guidelines. Any experience of GAMP5 would be highly beneficial.
Experience of writing validation documentation
knowledge of FDA/MHRA Regulations
Good practise guidelines including; GLP and GMP
General knowledge of IT infrastructure technologies such as networking, servers and Active Directory
CSV Engineer / Systems Validation Engineer
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