Senior Quality Engineer Process Validation

Job description

Senior Quality Engineer Process Validation – 9 months  

In this job, you will provide validation support from initial development right through to when the products have been commercialized. You will be part of a cross-functional team.


What you will do:

  • Provide expert QE technical guidance to qualification and validation activities, collaborating with other Engineering & QA teams
  • Document and provide support of qualification/validation protocols/reports
  • Have a strong understanding of product design & functionality at a highly competent level to contribute to decision making process on product acceptance standards
  • Lead & support others in root cause investigations; drive problem solving initiatives for quality issues


What you will need:

  • Bachelors’ degree (Level 8 NFQ) in Engineering/ Science and desirably with a minimum of 5 years relevant experience.
  • Knowledge of regulatory requirements and guidelines including 21 CFR parts 210, 211, 21 CFR part 820, ICH requirements and ISO 13485 requirements is necessary.
  • Knowledge of combination products, statistical requirements or software validation requirements an advantage.


What you will receive:

  • Competitive Salary & Comprehensive Benefits Package, Training & Development



To apply for this position please contact Chloe Walsh at Sigmar Recruitment T: +353 91 455305 E:  

All applications will be treated with the strictest of confidence.  Sigmar will never forward your CV to a third party without prior consent


Following your application for this specific role, Sigmar may contact you regarding other positions that we feel you may be suitable for. If you do not wish to be contacted about other opportunities please let us know. For further information please refer to the Privacy Statement on our website.