Validation Engineer
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- Cambridge
- Posted 14th Nov 2008
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Posted by:
Polytec Personnel
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Salary:
£neg
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Job Type:
Permanent
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Address:
Orwell House
Cowley Road
Cambridge
CB4 0PP
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Reference:
20794
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This job has been viewed
113 times
since it was posted.
Job Description
Our clients are looking for a validation engineer initially for a 6mth contract to ensure that their production facility is adequately validated, to work with the process development engineers in order to generate installation and operation qualification documentation & to manage and report on the progress of IQ and OQ activities. You will also define and generate the process qualification documentation, review externally produced documentation related to validation activities & review and ensure mitigation of process risk assessments.
Skills: -Sound understanding of quality systems and their management-Excellent knowledge of the FDA regulations-Thorough understanding of 13485 and GAMP -Good project management skills-Able to produce concise reports-Highly competent with Microsoft Word
Education: -HND/Degree -Full Driving Licence preferred
Experience: -A minimum of four years experience in a similar role within the medical device industry, ideally with two separate companies-Working within an automated manufacturing environment would be desirable-Involvement in audits with notified bodies
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