Ref. 01292
Isolator Validation Engineer
Asset Recruitment is recruiting an Isolator Validation Engineer for a contract role, on behalf of our client, a growing pharmaceutical manufacturer in Carlow.
The successful candidate will support Isolator Airflow Visualisation/ VHP/HVAC Qualification.
Primary 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.
Requirements:
• Experience in authoring, reviewing, executing and approving Isolator Airflow Visualisation/ VHP/HVAC Qualification documents.
• 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.
• Equipment and process validation.
• Demonstratable experience of leading technical related projects.
• Experience in sterile Fill-Finish processes and equipment.
• Knowledge of process monitoring systems, automation systems (DeltaV), operational intelligence & data systems (Pi System) within a GMP manufacturing environment would be beneficial and desirable
• Proficiency in Microsoft Office and job-related computer applications
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