Ref. 01273Cleaning Validation EngineerAsset Recruitment is recruiting a Cleaning Validation Engineer for a contract role, on behalf of our client, a growing pharmaceutical manufacturer in Carlow. The successful candidate will support Cleaning Validation including Recovery/Cleanability studies.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.• 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.• Serve as validation representative for cross functional projects and represent the validation team at global technical forumsRequirements:• Experience in cleaning validation including but not limited to CD & PQ of mobile vessels (CIP) and parts washers (COP) including recipe development & optimisation, cleaning verification, cleanability and recovery studies using TOC, ICP & swab methods, acceptable residual limit determination, worst case soil matrices & strategy development.• Considerable experience in a comparable role, with experience operating as individual contributor adding value to the business in a GMP manufacturing setting.• 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.• Exception / Deviation Management and Change Control.• Demonstratable experience of leading technical related projects.
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