CSV Equipment Validation Engineer

ROLE: CSV Equipment Validation Engineer LOCATION: Columbia, Missouri DURATION: 8 months with extension # of Positions: 2 ESSENTIAL DUTIES AND RESPONSIBILITIES: Responsible for supporting software validation for the following equipment: o Beckman Coulter CytoFLEX S o Beckman Coulter Optima AUC o Beckman Coulter Vi-CELL XR o bioM rieux BACT/ALERT 3D Dual-T o Bio-Rad QX200 AutoDG ddPCR o ChemoMetec NucleoCounter NC-200 o PerkinElmer EnVision Multimode Plate Reader o Thermo Fisher Scientific NanoDrop UV-Vis o Agilent OpenLab CDS o Bruker MPA II FT-NIR Spectrometer o Meso Scale Discovery (MSD) Discovery Workbench Responsible for authoring and execution of the following validation deliverables for several Lab equipment: o Electronic Record/Electronic Signatures (ER/ES) revision for SOPs o Release Notes Assessment o Regulatory Impact Assessment o System Validation Master Plan o Risk Assessment o Functional Requirements Specification Plan o System Design Specification Plan o Traceability Matrix o Test Plan & Test Scripts o Validation Final Report Plan Qualifications: Experience with Computer System Validation on Equipment Qualification projects Experience coordinating IQ/OQ executions with Equipment vendors and client IT departments Experience evaluating quotes from vendor for the purchase of any additional services (software installation, IQOQ, calibration, etc.) 5+ years of experience in Life Sciences industry experience with validation of software in equipment