Description
FITS is seeking a Validation Services Engineer to review and validate medical-device validation documentation, including OQ, PQ, TMV, and IPM records. The role uses automated tools to extract and filter data, assesses accuracy and site alignment, identifies discrepancies and remediation needs, cross-checks records against master validation plans and risk assessments, and escalates risks or blockers. Candidates need a bachelor's degree in engineering, five years of validation experience in the medical-device industry, bilingual English and Spanish ability, and experience with regulated environments, data analysis, and document management systems.
