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