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Validation Engineer

  1. West
Carlow
  1. Contract
Competitive
  1. Commissioning, Qualification and Validation
09-01-2024
32070

This vacancy has now expired

Validation Engineer - Carlow - 11-Month Contract

With worldwide demand for their life-changing oncology treatment increasing; one of our global pharmaceutical clients is looking for a Validation Engineer to join their team to support multiple capital projects taking place onsite in Leinster.

This is a fantastic opportunity to work on a state-of-the art fill-finish facility and the company’s first stand-alone vaccine and biologics plant outside the US. 


Essential Duties and Responsibilities for this role include, but are not limited to, the following:
  • Design/Author/Review/Approve/Execute qualification/validation documentation and cycle development studies in line with the standard approval process.
  • Design/Author/Review/Approve/Execute Execution/development of change controls.
  • Resolving technical issues encountered during study execution.
  • Engagement with Production, Maintenance and Quality representatives in the assigned area of operations during execution of Cycle Development & Performance Qualification activities.
  • Technical input into quality notification by authoring/reviewing/approving investigations.
  • Perform root cause analysis of system failures, substandard performance, using standard tools and methods, to resolve machine and system issues.
  • Support continuous improvement through Lean Six Sigma methodologies.

Requirements:
  • Knowledge of CTU equipment qualification.
  • Knowledge of thermal mapping equipment.
  • Thermal mapping skills.
  • Exception / Deviation Management and Change Control.
  • Demonstrable experience of leading technical related projects.
  • Knowledge of process monitoring systems, automation systems (DeltaV), operational intelligence & data systems (Pi System) within a GMP manufacturing environment would be beneficial and desirable.
  • Evidence of continuous professional development is desirable.
  • Knowledge of regulatory/code requirements to Irish, European and International Codes, Standards and Practices.
  • Ability to analyse and interpret complex data, and link to equipment performance and out of specification findings as appropriate.
  • Report, standard.

If you are interested, please apply now for immediate consideration and further information.



The candidate must have the rights to work in the location stated in the job advert.

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