Jobs at Personalis

Lead design, development, testing, deployment, and maintenance of regulated clinical-lab software. Provide technical leadership, mentor engineers, improve CI/CD and integrations, ensure compliance (HIPAA, CLIA, CAP, FDA), support validation, and collaborate with stakeholders to deliver secure, reliable applications.

Lead computer system validation (GAMP 5) and software quality/compliance for clinical genomics software. Author/execute validation deliverables, enforce FDA/ISO/IEC regulatory alignment, run risk assessments (FMEA), integrate AI governance into QMS, support eQMS configuration, collaborate on cybersecurity and cross-functional design control documentation, and serve as SME during audits.

Lead the global internal audit program and external audit readiness for a GxP-aligned clinical laboratory. Oversee audit lifecycle, regulatory inspections, executive reporting, CAPA investigations, and continuous improvement. Partner with cross-functional leaders, mentor audit staff, and ensure compliance with CLIA, CAP, ISO 13485, 21 CFR 820, IVDR, GCP, and GCLP.

The Histotechnician 2 processes FFPE specimens, performs staining and microtomy, generates digital slide images, ensures quality, and maintains documentation.

Personalis seeks great candidates to join their teams. Applicants are encouraged to apply even without a specific role posted. They offer a comprehensive compensation package and are committed to diversity and inclusion.

Support clinical testing operations by managing inbound/outbound communication with patients, physician offices and labs, coordinating specimen procurement and mobile phlebotomy, documenting case information in Salesforce and LIMS, collaborating with lab, billing and clinical teams, resolving service issues, and contributing to process improvements to ensure timely delivery of patient reports.

The role involves architecting, designing, and modernizing software systems for human genome sequencing, incorporating backend services and web applications, with a focus on automation and system integration.