Isolator Validation Engineer

1 week ago


The Municipal District of Carlow, Ireland QCS Staffing Full time

Isolator Validation Engineer - Ireland, Carlow - 11 Month Contract

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.
Desirable Experience
  • Experience in authoring, reviewing, executing, and approving Isolator Airflow Visualisation/ VHP/HVAC Qualification documents.
  • 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.
Seniority level
  • Entry level
Employment type
  • Contract
Job function
  • Quality Assurance

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