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Job Title:  Validation Engineer

Req ID:  28099
Job Category:  Processing Operations

Galway, G, IE, Galway

Description: 

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 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

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

Duties - cont'd

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

Education Degree

Bachelor's Degree

Required Experience

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

 

STERIS is a leading provider of products and services that meet the needs of growth areas within Healthcare: procedures, devices, vaccines and biologics.  We exist to fulfill our MISSION TO HELP OUR CUSTOMERS CREATE A HEALTHIER AND SAFER WORLD. STERIS is a $3B, publicly traded (NYSE: STE) company with approximately 16,000 associates and Customers in more than 100 countries.

STERIS strives to be an Equal Opportunity Employer.  

Req ID:  28099
Job Category:  Processing Operations

Galway, G, IE, Galway


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