Genentech · New York
Software Engineeringposted 2w ago
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 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.
Who You Are
Education & Experience: Bachelor’s degree (preferably in Engineering or Life Sciences) with a minimum of 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.
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.
The expected salary range for this position based on the primary location of Oregon is $93,000 - $172,800. Actual pay will be determined based on experience, qualifications, geographic location, and other job-related factors permitted by law. A discretionary annual bonus may be available based on individual and Company performance. This position also qualifies for the benefits detailed in this link.
This is an on-site position.
Relocation benefits are approved for this posting.
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Genentech is an equal opportunity employer. It is our policy and practice to employ, promote, and otherwise treat any and all employees and applicants on the basis of merit, qualifications, and competence. The company's policy prohibits unlawful discrimination, including but not limited to, discrimination on the basis of Protected Veteran status, individuals with disabilities status, and consistent with all federal, state, or local laws.
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