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Engineering Specialist (Validation)

  • Sector: Engineering
  • Contact Email:
  • Job Ref: 20862

This is an exciting opportunity for an Engineering Specialist (Validation) interested in a new challenge in a cGMP regulatory environment. The successful candidates will support several aspects of Validation.

Key Roles & Responsibilities

  • 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.
  • Accountable for compliance via documentation completion, risk assessments, closing out corrective actions, participation in audits and inspections and proactively highlighting any issues around compliance.


  • Knowledge of CTU equipment qualification
  • Knowledge of thermal mapping equipment
  • 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
  • Equipment and process validation.
  • Sterile Fill-Finish processes and equipment.


Relevant technical qualification(s) in Applied Pharmaceutical / Biological / Chemical sciences or applied Technical / Engineering qualification.

For a confidential discussion and more information on the role, please contact Kevin Griffin

Kevin Griffin

(021) 2427108