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Validation Engineer

Job description

Validation Engineer

I'm seeking an experienced Validation Engineer to join an expanding medical device company here in Galway. This job is open due to new projects and expansion so it's a brilliant time to join the company.

You will manage all aspects of Equipment & Computerised system validation for any software systems used in the manufacture of medical devices.

The hiring manager told me that you will be join a great team and culture so personality fit is very important for this job too!

 
Your Responsibilities:

  • Prepare software validation protocols for the Equipment Engineering group.  Execute these protocols and ensure sign-off is obtained at each stage.
  • Create and execute protocols and reports, reviews Equipment Function Spec's and provides direction and support on validation strategy and plans.
  • Work with Quality department to ensure equipment validations are in line with  global and site validation standards.
  • Take responsibility for correctly carrying out and maintaining all validation and associated documentation for equipment.
  • Develops and enhances cross-functional team relationships and works cross-functionally to identify and resolve technical and organisational issues.
  • Ensure best validation practices are employed by the Equipment Engineering Group so as to maximise effectiveness and minimise non-value added work.
  • Communicates effectively & Efficiently with cross-functional teams on project tasks
  • Ensure regulatory compliance with  global  software validation requirements.
  • Project management of sustaining projects
  • Actively pursues continuous improvement
  • Generates quotations for new and upgarde software systems.

 

Experience:

  • Level 8 qualification in Science/Engineering or Quality.
  • Minimum of 3 years’ experience in a Validation role within medical device, biotechnology or pharmaceutical manufacturing organization.
  • Proven track record and performance executing validation activity independently or as part of a team in multiple areas.
  • Availability to travel as required.
  • Ability to support weekend work as required

For more information, please contact Emma on 091 455 307.

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