ResponsibilitiesManage qualification and lifecycle activities for QC laboratory instruments and software systemsAuthor and execute URS, DQ, IQ/OQ protocols, validation plans, risk assessments, and summary reportsPerform Computer System Validation (CSV) activities and software testingSupport change controls, deviations, investigations, and CAPA implementationMaintain asset management records, calibration schedules, and preventive maintenance activitiesCoordinate with vendors for installation, qualification, and troubleshooting activitiesQualificationsBachelor's or Master\'s degree in Engineering, Biology, Chemistry, or related field2–4+ years of Validation, CSV, or laboratory systems experience in a GMP environmentStrong knowledge of cGMP, 21 CFR Part 11, GAMP, Data Integrity, and Electronic Records requirementsExperience with change controls, deviations, investigations, and quality systemsFamiliarity with laboratory instruments, computerized systems, and validation documentation#J-18808-Ljbffr