Sr. Engineer, GxP Systems

Job description

JOB DESCRIPTION: Title : Sr. Engineer, GxP Systems Reports to : Director, Product Management Function : Digital: Location : Norwood, MA: The Role: ModernaTX, Inc. seeks a Sr. Engineer, GxP Systems for its Norwood, Massachusetts location. Here’s What You’ll Do: Design, deployment, validation and management for digital enterprise instrumentation systems. Collaborate with business analysts and software/automation engineers in the complete product lifecycle management of various digital quality enterprise and laboratory instrumentation systems including the Chromatography Data System (Chromeleon), Scientific Data Management System (LogiLab SDMS), and data acquisition and analysis software for microplate readers (SoftMax Pro). Ensure all validated laboratory systems comply with FDA 21 CFR Part 11, GAMP 5, and USP 1058 Analytical Instrument Qualification (AIQ) requirements. Translate system, equipment, and data integration requirements from digital and business teams for deployment into the appropriate digital lab system solution. Manage system change controls and configuration updates and validate changes, ensuring that laboratory systems comply with regulatory and industry best practic...