# Senior Quality Assurance Engineer - Cell & Gene Therapy at Genentech

- Company: Genentech
- What the company does: Genentech discovers, develops, manufactures and commercializes treatments for patients with serious and life-threatening medical conditions. Backed by North Carolina Biotechnology Center.
- Company website: https://gene.com
- Type: Startups
- Level: Senior
- Location: Hillsboro
- Work setup: On-site
- Pay: $93K to $173K base salary per year (USD)
- Posted: 2026-09-10
- Apply by: 2026-10-25
- Apply: https://roche.wd3.myworkdayjobs.com/en-US/ROG-A2O-GENE/job/Hillsboro/Senior-Quality-Assurance-Engineer_202608-121515-1
- Page: https://www.1752.vc/careers/jobs/genentech-senior-quality-assurance-engineer-cell-and-gene-therapy/

## About the role

This role is a valuable part of our Hillsboro Innovative Therapies (HIT) Quality Systems and Validation team, which is committed to achieving our mission of delivering novel and exciting biopharmaceutical technologies to patients. As a member of this dedicated cross-functional team, you will drive production start-up activities and establish the foundational quality approach for new facilities.

## What they're looking for

- 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 physical demands (sitting/standing for extended periods, lifting up to 25 lbs) and a willingness to travel up to 30% to other sites as required