Ref. 01274Validation EngineerAsset Recruitment is recruiting a Validation Engineer for a contract role, on behalf of our client, a growing pharmaceutical manufacturer in Carlow.The successful candidates will support several aspects of Validation. The roles available that will require experienced, energetic and committed engineers are in the following areas:• Sterilisation – Autoclaves, SIP of vessels• Cleaning – Parts Washer and CIP of vessels• Isolator (Filling, Sterility & Material Transfer isolators) – HVAC, VHP, E-Beam and Dehydrogenation systems• Controlled Temperature Units (CTU) – Temperature/Humidity Mapping• Filter Validation• Container Closure Integrity ValidationPrimary 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.• Perform root cause analysis of system failures, substandard performance, using standard tools and methods, to resolve machine and system issues• Engagement with Production, Maintenance and Quality representatives in the assigned area of operations during execution of Cycle Development & Performance Qualification activities.Requirements:• 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.• Experience in sterile Fill-Finish processes and equipment.• Knowledge of CTU equipment qualification• Knowledge of thermal mapping equipment• Thermal mapping skills
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