CSV Analyst

Our client is currently building a new facility and need a CSV Analyst to help validate and deliver multiple systems to the site. These will include MES, LIMS and other site critical systems. Successful candidates witll assist local SMEs to ensure data integrity and local validation deliverables for the site including local adoption. You will create and maintain all local validation deliverables at the site and create Installation Verification Instruction (IVI) IQ/OQ for systems. You will create test plans and ALM Test Scripts as needed. You will also work with Service Now and Trackwise to create Change Request, Incidents, and Problems. More responsibilities:Responsible for supporting the validation activities for local and global systemsExperience in developing and maintaining validation documentation including validation places, test protocols, test scripts, and summary reports to align with company SOP and regulatory standardsCoordinate with technical evaluation with site subject matter experts (SMEs) of new and existing systems from a DI and CSV perspectiveResponsible for coordination with cross-functional teams to ensure the alignment of the validation activitiesPerform data integrity gap assessment and develop remediation plan for computerized systemsResponsible for creating CAPA’s/Deviations and Change Requests in ServiceNow and TrackwiseRequirementsBS in Computer Science or technical field5-10 years of experience with CSVStrong understanding of SDLC in an FDA regulated environmentExperience creating test plans and writing test scripts in support of CSV projectsHigh level of initiative and driveAbility to work with multiple stakeholders and drive projects through to fruitionThis is an onsite position minimum 4 days per week so candidates must be local or willing to be local for duration of the contract