Senior Quality Engineering Specialist

Role: Senior Quality Engineering Specialist supporting GxP software, equipment, calibration, and vendor oversight within Prime Medicine’s quality assurance team. Responsibilities: execute qualification activities (IQ/OQ/PQ), draft and review validation protocols, conduct risk-based vendor assessments, support supplier audits, and maintain compliance documentation; oversee calibration and preventive maintenance schedules; participate in audits and inspection readiness. Requirements: Bachelor’s in a scientific, engineering, or technical field; 4+ years in regulated life sciences, with experience in equipment qualification, software validation/CSV, and supplier quality. HighValue: biotech/gene therapy environment, GxP compliance, equipment qualification, software assurance, vendor assessments, and calibration management. WorkSetup: based in Cambridge, MA, with operational support and cross-functional collaboration.