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Validation Engineer
This job has expired, and cannot be applied for.
- Posted By: Polytec Personnel
- Address:
- Contact:
- Date Posted: 8th Oct 2008
- Salary: £neg
- Location: Cambridge
- Reference Code: 20794
- Views Since Posting: 94
- Full 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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