Validation Engineer

Role: Validation Engineer – QMS Remediation ProgramLocation: Boston, MA Duration: 18+ months with potential extensionOverviewWe are supporting a large-scale Quality Management System (QMS) remediation initiative for a leading medical device organization operating under FDA oversight. This program is focused on identifying and closing compliance gaps while strengthening adherence to 21 CFR Part 820 and ISO 13485 across critical quality functions including Validation, CAPA, Complaints, and Design Controls. This is a highly visible, audit-driven initiative requiring strong onsite execution, documentation remediation, inspection readiness support, and long-term compliance improvements. Position SummaryWe are seeking Validation Engineers (Associate through Senior levels) to support execution-focused validation remediation activities within a regulated manufacturing environment. This is a hands-on role centered on validation gap assessment, protocol execution, and remediation of legacy documentation. Key ResponsibilitiesExecute and remediate validation activities including IQ/OQ/PQ and process validation Identify, assess, and close compliance gaps against FDA and ISO requirements Review, update, and remediate legacy validation documentation Author validation protocols, reports, and summary documentation Collaborate cross-functionally with Quality, Manufacturing, and Engineering teams Support audit readiness efforts and regulatory inspection activities Qualifications5–10+ years of validation experience within medical device or other regulated industries Strong hands-on expertise in execution and authoring of IQ/OQ/PQ documentation Deep understanding of 21 CFR Part 820 and ISO 13485 requirements Prior experience supporting remediation initiatives or audit-driven programs Experience supporting validation execution and/or documentation activities Strong organizational skills and attention to detail Preferred QualificationsExperience supporting FDA inspections, warning letter remediation, or compliance recovery initiatives Exposure to CSV and 21 CFR Part 11 requirements Experience working within high-volume documentation remediation programs