Genentech discovers, develops, manufactures and commercializes treatments for patients with serious and life-threatening medical conditions. Backed by North Carolina Biotechnology Center.
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
More about this 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. You will have the opportunity to collaborate closely with key stakeholders in Engineering, Operations, and global network teams to ensure our systems and processes are safe, compliant, and inspection-ready.
The Opportunity
As a Senior Quality Assurance Engineer , you will provide day-to-day Quality Oversight for site qualification, equipment validation, and computer system validation during critical production start-up activities. You will act as the site Quality and Regulatory Subject Matter Expert (SME), ensuring that all local processes and automated systems strictly align with current Good Manufacturing Practices (cGMPs). Key responsibilities include:
Lead Quality Oversight: Provide technical and regulatory oversight for site qualification and validation activities, including advanced...
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