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Solutions Recruitment
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Hebburn, Tyne and Wear
Validation Engineer
Overview
My client is a leading innovative manufacturer of cutting-edge products for the medical device and healthcare sectors. With a proud history and enviable working environment, my multi-site client seeks a Validation Engineer to join their Quality team at their manufacturing site in Tyne & Wear. Reporting to the Quality Assurance Manager, the Validation Engineer will be tasked with ensuring all site validation needs are met, including: all production, service, digital processes, re-validation of existing processes and initial validation of new processes. Main responsibilities Creating Validation Master Plans and associated protocols Create or amend standard operating procedures in accordance with the results of the validation” Creating validation and related working forms Supporting site cross-functional technical writing needs Assist in the implementation of the validation protocols and write the validation reports Support cross-functional risk management activities Support in the optimization of production processes Preparation of plans for maintenance, service, calibration, re-validation and cleaning of test and production equipment Policing and coordinating maintenance, service, calibration, re-validation and cleaning Advise the business on current best practice in validation and keep abreast of changes Contribute to continuous improvement projects To be considered for the role, it is essential that you possess a Degree in a relevant engineering subject and demonstrable experience gained in validation/qualification engineering within the medical, medical device, bioscience or pharmaceutical manufacturing sectors. Key selection criteria GMP experience Considerable, demonstrable experience gained in medical device or pharmaceutical manufacturing Good knowledge of QMS systems for medical devices e.g. EN ISO 13845, 21 CFR 820 etc. Excellent communication skills Natural leader and mentor Knowledge and experience of project management methodologies and implementation Knowledge and experience of continuous improvement This is an excellent opportunity to join an industry leading, cutting-edge manufacturer in their field who can offer an enviable working environment. This job was originally posted as www.totaljobs.com/job/89629985