Ref. 01273
Cleaning Validation Engineer
Asset 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 forums
Requirements:
• 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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