Role: cqv engineerlocation: united statesduration: 12+ monthsthis position is open exclusively to people who are eligible to work in usakey responsibilities:execute commissioning and qualification activities (iq/oq/pq) for manufacturing equipment, utilities, and facilitiesdevelop and review validation protocols and reports for equipment and processesperform test method validation, including gr&r and statistical analysisensure compliance with gmp, qsr, iso *, and other regulatory requirementssupport risk management activities, including fmea and risk assessmentscollaborate with engineering, manufacturing, and quality teams during npd and tech transferinvestigate deviations, non-conformances, and support capa activitiesassist with equipment calibration and preventive maintenance programssupport audits and regulatory inspections as requiredqualifications:bachelor's degree in engineering or related scientific field3–8+ years of cqv/validation experience in medical device, pharma, or biotech industrystrong knowledge of validation lifecycle (iq/oq/pq) and fda regulations (gmp, qsr)experience with statistical tools, gr&r, and process capability analysisfamiliarity with risk management principles (fmea, iso *)