Validation Engineer III

Role: Validation Engineer III focused on supporting late-phase and commercial biologics manufacturing validation activities. Responsibilities: lead the development and execution of validation strategies for cleaning, shipping, process validation, and equipment; author validation documentation including protocols, reports, and risk assessments; troubleshoot validation discrepancies; support transition to digital validation systems; and assist in inspection readiness and audits. Requirements: bachelor’s degree in engineering or related field; 7+ years of validation experience, with knowledge of industry standards, US FDA CFRs, EMA, ICH regulations, and risk management; strong understanding of process equipment, utilities, and systems; excellent problem-solving, communication, and organizational skills. Preferred: experience leading validation projects, working with shipping, cleaning, utilities, and computerized systems. High-value: biologics, late-phase and commercial manufacturing, process and cleaning validation, global validation strategies, digital validation systems, regulatory compliance, and cross-disciplinary collaboration. Work setup: location in Redmond, WA.