Our Client, a leading provider of testing and technical services to the medical device and pharma industries, are hiring for a Validation Engineer.
Major 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
Experience and Education Required:
- 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 please feel free to contact Patrick Brady on 091-507516/patrick.brady@cpl.ie.
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