Job OverviewA unique opportunity has arisen for a skilled validation specialist to join our team in a cGMP regulatory environment.Sterilisation – Autoclaves, SIP of vesselsCleaning – Parts Washer and CIP of vesselsIsolator (Filling, Sterility & Material Transfer isolators) - HVAC, VHP, E-Beam and Depyrogenation systemsControlled Temperature Units (CTU) – Temperature/Humidity MappingFilter ValidationKey Responsibilities:We are seeking a highly motivated individual who can design/author/review/approve/execute qualification/validation documentation and cycle development studies in line with the standard approval process.The successful candidate will be required to resolve technical issues encountered during study execution.This role involves engagement with Production, Maintenance and Quality representatives in the assigned area of operations during execution of Cycle Development & Performance Qualification activities.The ideal candidate will provide technical input into quality notification by authoring/reviewing/approving investigations.This position requires the ability to perform root cause analysis of system failures, substandard performance, using standard tools and methods, to resolve machine and system issues.The successful candidate will support continuous improvement through Lean Six Sigma methodologies.The job holder will be required to work both independently and in a cross-functional team to accomplish validation project objectives.