Cqv Engineer I
CurrentCurrently at Janssen Malvern supporting Project Polaris Sept 2023 - PresentWas at AstraZeneca from March 2023-Sept 2023Was at Iovance Biotherapeutics from Nov 2022-Mar 2023Write C/Q/V documents following established standards and templates, including but not limited to the following:Commissioning FormsC/Q/V Protocols and Summary ReportsStandard Operating ProceduresImpact AssessmentsSpecifications (URS/FRS/DDS)FATS/SATsPerform field/site activities including, but not limited to, the following:Execution of commissioning forms and witnessing of vendor start-up and testing.Execution of C/Q/V protocols.Compile data and prepare reports for completed C/Q/V activities including ETOPs, protocol data packages, etc.Assist in deviation investigation and resolution of problems and issues encountered during field execution activities.Work with the Project Delivery department or CM for start-up and vendor testing. Witness and troubleshoot as required.Primary responsibilities include C/Q/V of equipment and systems, including CSV and automation, supporting pharmaceutical, biotech, and medical device industries.