Within this role you will be responsible for qualification activities for Controlled Temperature Units (e.g. freezers, incubators, walk-in cold rooms) and warehouses in accordance with cGxP, regulatory requirements and industry trends within the frame of Industrial Operations and major capacity expansion and transformation projects for the delivery of highly digitalized and automated suites for the production (upstream, downstream) of drug substance for biologics.A typical day might include, but is not limited to, the following:Generating, executing and/or reviewing master and completed qualification and validation protocols, summary reports and associated data for conformance to regulations, SOPs, specifications and other applicable acceptance criteriaAnalysing the results of testing and determines the acceptability of results against pre-determined criteriaInvestigating and troubleshooting problems which occur and determines solutions or recommendations for changes and/or improvementsReviewing, editing and approving deviation notifications, deviation investigations, and corrective actionsReviewing and approval change controls, SOPs, reports and other documentationCoordinating with other departments or outside contractors/vendors to complete validation tasksManaging projects and prepares status reportsProviding oversight to contingent workers may be a requirement