Senior Validation Engineer Hybrid RoleResponsibilities will include (but not limited to):Act as the project lead for qualification of QC equipment and its associated softwareDesign, execute, manage, and implement QC instrument/software qualification documents such as (but not limited to): User Requirement Specification (URS), Design Qualification (DQ), validation plans, equipment IOQ protocols, software test scripts, configuration specifications, risk assessments, qualification summary reportsAuthor/execute computer system validation scripts using an electronic validation database (ALM), or paper-basedOwn change controls specific to the qualification of QC instruments and its associated softwareUpdate the asset management database to reflect new assets, calibrations, preventative maintenancesAuthor instrument operational SOPs as neededCoordinate/interface/host vendors on siteChampions qualification deviations/software defects, identifying root causes and Corrective Actions/Preventive Actions (CA/Client)Acts as the liaison between Digital Plant (IT) and lab departmentsExecute periodic assessments/decommissioning, as neededQualifications and Experience Required:Bachelor's degree in relevant scientific, engineering, or computer based area, with minimum of 5 years' experience in the biopharmaceutical industry or equivalent combination of education and validation/CSV/lab experienceQuality management system experience including: document control/management, change controls, investigations, deviations, electronic validation databases, asset management databaseKnowledge of cGMP regulatory requirements, computerized analytical systems, i.e., 21 CFR part 11, GAMP, electronic record/electronic signature, data integrity, disaster recoveryIncumbents must have demonstrated experience in solving complex technical issues and have the skills and understanding to troubleshoot process defectsDemonstrated success in cross functional influencing, strong communication, and collaboration skillsWorking knowledge of laboratory systems such as: Empower, NuGenesis, and other software programs, including Microsoft Office Applications, preferredMust have computer system validation experienceMust have equipment validation experienceMust have GMP experience