Senior Quality Assurance Engineer - Cell & Gene Therapy

About the role

This role sits in the Hillsboro Innovative Therapies (HIT) Quality Systems and Validation team, which aims to deliver novel biopharmaceutical technologies to patients. As a Senior Quality Assurance Engineer, you will drive production start-up activities and set the foundational quality approach for new facilities, working with Engineering, Operations and global network teams so that systems and processes are safe, compliant and inspection-ready.

Key responsibilities

• Provide day-to-day quality oversight for site qualification, equipment validation and computer system validation during production start-up, acting as the site Quality and Regulatory Subject Matter Expert aligned with cGMPs.
• Review and approve lifecycle documentation such as Validation Master Plans, User Requirements, Protocols, deviations and Summary Reports.
• Support Engineering and Design during build and deploy phases, helping define user requirements and design specifications for production and laboratory equipment.
• Maintain inspection readiness of assigned areas and present and defend the validation program during regulatory audits.
• Assess and approve engineering modifications, process changes and CAPAs, and manage the validation risk log.
• Partner with multi-site and global teams to implement validation best practices and benchmark against industry standards.

Required profile

• Bachelor's degree (preferably in Engineering or Life Sciences) with at least 8 years of pharmaceutical/biopharmaceutical experience, or a Master's degree with at least 6 years of relevant experience; cell therapy experience preferred.
• Sound knowledge of engineering principles, qualification concepts and regulatory requirements for system performance and lab design/start-up.
• Strong understanding of US and EU cGMPs, validation guidelines and risk assessment methods such as PHA, FMEA and FTA.
• Excellent verbal and written communication and collaboration across cross-functional teams.
• Able to sit or stand for long periods, lift up to 25 lbs, and willing to travel up to 30% to other sites; the position is on-site.

Required skills

• Technical familiarity with automation and execution systems such as Delta V/SCADA, Syncade MES, BAS, EBR and Pi Data historian.
• Validation oversight, including CSV, and risk-based validation approaches.

What we offer

• Expected salary range of $93,000 - $172,800 for the Oregon location, depending on experience, qualifications and location.
• A discretionary annual bonus based on individual and company performance.
• Relocation benefits are approved for this posting.