Validation Engineer - Galway

Job Overview

My client, a leading multinational are looking for a Validation Engineer to join their team in Galway.

Ideally you will have a minimum of 2 years' experience in equipment qualification within the pharmaceutical industry.

The Position…

  • Permanent Position
  • Monday to Friday role with flexible working hours. Half day on a Friday!
  • Attractive salary and benefits package on offer, including 25 days holiday.

Responsibilities: (A Snapshot…)

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:

  • 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

Requirements:

  • 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

Next Steps:

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