» Validation Engineer

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

Cambridge, Cambridgeshire | Hourly rate: £neg.
View more jobs : Engineering | Temporary