Job Title:  Validation Engineer

Position Summary

This Validation Engineering role is a position within the engineering team based at the STERIS Galway laboratory. The site provides testing and technical services to the medical device and pharma industries.

Duties

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

Duties - cont'd

Test Method Validation:

• Design and execute Test Method Validation studies using appropriate approach (e.g. 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 Degree

Required Experience

• 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
• Excellent written and spoken English
• Technical writing experience
• 6 sigma and Minitab experience an advantage