At STERIS, we help our Customers create a healthier and safer world by providing innovative healthcare and life science product and service solutions around the globe.
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
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
* Bachelor's Degree in Science or Engineering General
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
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