Validation Technician

Position Summary

This Validation Technician role is a position within the Validation 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:

• Support development and execution of Test Method Validation studies
• 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
• Support problem solving of validation issues
• Review and of international test standards
• Review of equipment calibration certificates detail and compliance with acceptance criteria

Education Degree

Required Experience

Experience and Education Required:

• Minimum 3rd level relevant science or engineering degree
• Working in a regulated environment: minimum 2 years
• Excellent written and spoken English
• Technical writing experience
• 6 sigma and Minitab experience an advantage

Preferred Experience

Skills