Senior Engineer, Quality Engineering

Role: Lead validation and qualification activities within the Quality Assurance department to support commercialization of Arrowhead’s RNAi therapeutics. Responsibilities: serve as SME on qualification, cleaning validation, process validation, and CPV; review and approve validation documentation and procedures; mentor QA team members; collaborate cross-functionally to evaluate validation data; support audits and change controls; develop and oversee periodic reviews of validated systems. Requirements: bachelor’s degree in science with 15+ years’ experience in cGMP manufacturing, validation, or quality roles; strong knowledge of GMP regulations (21CFR Part 210/211, EU Annex 11/15, ICH Q7, 21CFR Part 11); attention to detail and organizational skills; ability to manage multiple priorities independently; proficiency in MS Word and Excel. Preferred: experience with electronic document management systems. HighValue: validation expertise supporting biologics or RNAi-based therapeutics manufacturing; compliance with GMP standards; involvement in commercial-scale processes. Location: Wisconsin; salary range $125,000–$140,000; candidates must have legal work authorization.