Validation Engineer - Galway
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.
- 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…)
- 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
- 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
Click Apply now to review the full details and job description for this fantastic opportunity.