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Validation Quality Engineer

  • Sector: Engineering
  • Contact Email: michelle.mcinerney@collinsmcnicholas.ie
  • Job Ref: 18813

Our Client based here in Galway are looking to hire a Validation Quality Engineer.


Responsibilities:

  • 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 the 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 solves validation issues.
  • Review and implement international test standards.

Requirments

  • Minimum 3rd level relevant science or engineering degree
  • 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

For more information or a confidential discussion about this role please contact Michelle Mc Inerney.

michelle.mcinerney@collinsmcnicholas.ie

091 706 717