Hiring: Senior Quality Assurance Engineer - Cell & Gene Therapy Company: Genentech Location: Hillsboro, OR Job Posted Time: 2026-09-11 11:45:12 Target Skills & Keywords : Manufacturing Execution Systems, Quality Assurance, SCADA About the job Experience: •8 years of pharmaceutical/biopharmaceutical industry experience, or a Master’s degree with a minimum of 6 years of relevant industry experience. Cell therapy experience is preferred. Required Skills: •As a Senior Quality Assurance Engineer •Lead Quality Oversight: Provide technical and regulatory oversight for site qualification and validation activities, including advanced Computer System Validation (CSV). •Approve Critical Validation: Review and approve essential lifecycle documentation such as Validation Master Plans, User Requirements, Protocols, deviations, and Summary Reports. •Support Engineering & Design: Collaborate during the build and deploy phases to support user requirement definitions and design specifications for production and laboratory equipment. •Defend Inspection Readiness: Maintain the compliance status of assigned areas to ensure a constant state of inspection readiness, and directly present and defend the validation program during regulatory audits. •Manage Risk & Changes: Provide technical quality assessments and approvals for engineering modifications, process changes, and Corrective and Preventive Actions (CAPAs) while managing the validation risk log. •Drive Continuous Improvement: Partner with interdepartmental, multi-site, and global corporate teams to implement validation best practices and benchmark against industry standards. Qualifications: •Validation & Engineering Expertise: Possess sound knowledge of engineering principles, qualification concepts, and regulatory requirements as they relate to system performance and laboratory design/start-up activities. •Automation & Systems Knowledge: Technical familiarity with the design, build, and deployment of automation and execution systems (such as Delta V/SCADA, Syncade MES, BAS, EBR, and Pi Data historian) within a regulated environment. •Regulatory & Risk Frameworks: Strong understanding of US and EU cGMPs, validation guidelines, and Risk Assessment Methodologies (such as PHA, FMEA, and FTA). •Decision-Making & Quality Analysis: Demonstrated ability to interpret complex Quality standards, make sound technical decisions, and troubleshoot cross-functional quality issues effectively. •Collaborative Communication: Excellent verbal and written communication skills with a proven track record of working collaboratively in cross-functional teams to achieve project milestones. •Physical & Travel Requirements: Ability to meet standard office Interested candidates, please apply directly through the job posting on company's career page or try via AI auto apply on this platform. Don't miss this opportunity to join a forward-thinking team!