
Isolator Validation Engineer
1 week ago
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.
- 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.
- Entry level
- Contract
- Quality Assurance
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