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Validation Engineer

  • Full Time
  • Permanent
  • Tyne & Wear
  • Competitive salary

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.

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