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.
-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
-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.