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Validation Engineer

Partnering again with our multinational client, AllPro Recruitment are now seeking a Validation Engineer to join their team. This is a permanent, full-time role and is a position within the engineering team based in their Galway laboratory. The site provides testing and technical services to the medical device and pharma industries.

Duties & Responsibilities:

Equipment Qualification:

  • Support laboratory equipment procurement and develop URS documentation
  • Work as a team to create, execute, and report on IQ, OQ and PQ protocols
  • Development of equipment related instructions and forms where required
  • Generate equipment measurement uncertainty budgets
  • Training of personnel in use of equipment and related documented instructions and forms

Validation

  • Design and execute Test Method Validation studies using appropriate approach (e.g. but not limited to: variable, variable destructive, or attribute Gauge R&R)
  • Establish statistically valid Test Method Validation sample sizes and acceptance criteria.
  • Assess equipment specifications and suitability for test method
  • Support equipment and test method improvements and update of test method related work instructions where required.
  • Training of personnel on test method related work instructions and forms.
  • Liaise with multiple departments to ensure timely completion of validation activities
  • Review statistical data and generate reports
  • Problem solve validation issues
  • Review and implement international test standards

Education

  • Minimum 3rd level relevant science or engineering degree

Required Experience

  • Equipment Qualification and Test Method Validation experience: minimum 2 years
  • Working in a regulated environment: minimum 2 years
  • 6 Sigma and Minitab experience an advantage
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