Validation Engineer

  • Contract
  • Carlow

Website TPM04608

Our client based in Carlow has an exciting opportunity for an Engineering Specialist (Validation) interested in a new challenge in a cGMP regulatory environment. The successful candidate will support several aspects of Validation predominantly Isolator and Filling Line qualification and studies.


  • 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.
  • Serve as validation representative for cross functional projects and represent the validation team at global technical forums.
  • Drive compliance of Global Policies, Procedures and Guidelines, regulatory requirements and execute current Good manufacturing Practices (cGMP) in the performance of day-to-day activities and all applicable job functions, ensuring consideration of the impact on GMP and compliance and decisions made.
  • Accountable for compliance via documentation completion, risk assessments, closing out corrective actions, participation in audits and inspections and proactively highlighting any issues around compliance.
  • Supporting regulatory audits and submissions as required.

Qualifications & Experience:

  • Relevant technical qualification(s) in Applied Pharmaceutical / Biological / Chemical sciences or applied Technical / Engineering qualification, the successful candidate will also have a proven track record in delivering excellence.
  • Knowledge of HVAC systems.
  • Knowledge of Isolator VHP qualification.
  • Knowledge of Sterilisation processes for Isolators.
  • Thermal mapping skills.
  • Exception / Deviation Management and Change Control.
  • Demonstratable 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.
  • Knowledge of regulatory/code requirements to Irish, European and International Codes, Standards and Practices.
  • Report, standards, policy writing skills required.
  • Equipment and process validation.
  • Sterile Fill-Finish processes and equipment.
  • Proficiency in Microsoft Office and job-related computer applications required.

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