Staff Process Engineer

Company Description

Guardant Health is a leading precision oncology company focused on guarding wellness and giving every person more time free from cancer. Founded in 2012 Guardant is transforming patient care and accelerating new cancer therapies by providing critical insights into what drives disease through its advanced blood and tissue tests real-world data and AI analytics. Guardant tests help improve outcomes across all stages of care including screening to find cancer early monitoring for recurrence in early-stage cancer and treatment selection for patients with advanced cancer. For more information visitand follow the company onLinkedInX (Twitter)andFacebook.

About the Role:

To enable Guardant Health to lead the disruption of cancer treatments through non-invasive cancer screening the Post Deployment Development Team is seeking a highly motivated Process Engineer to help support the evolution of the Guardant Health Shield product/assay from its current state into a high throughput production line. The Staff Process Engineer Lab Operations position will contribute to analyzing current Shield operations workflows and recommend areas for process improvements. This role is based in Redwood City CA and Palo Alto CA.

As a Staff Process Engineer you will support Shield Clinical Lab Operations and interface cross functionally with members of various departments including Technology Development Quality Assurance Bioinformatics Continuous Improvement and Automation Clinical Development. This position will be responsible for developing maintaining and using process monitoring tools to continuously improve the performance of our tests generating regulatory compliant scale-up Verification/Validation and tech transfer procedures the development and validation of process changes to enhance Shield performance and leading efforts to integrate automation LIMS and Technology Development to improve the operations of the clinical laboratory. An ideal candidate would have a high level of knowledge of Assay/Process/Method development and good documentation practice (GDP).

Essential Duties and Responsibilities:

• Act as a strategic liaison between Operations Technology Development Automation and other cross-functional partners to drive alignment and execution.

• Lead or contribute to the design development optimization and implementation of automated liquid handling processes systems and streamlined workflows.

• Plan studies in conjunction with R&D to identify KPIs process tolerances and failure modes.

• Drive continuous improvement within Screening Operations by analyzing workflows identifying bottlenecks and developing solutions to reduce test turnaround time reduce COGS and improve efficiency and product quality.

• Solve practical problems and deal with a variety of concrete variables in situations where only limited standardization exists.

• Advocate for the needs of the Lab Operations department.

• Collaborate with all functions within project teams.

• Develop strategies to support rapid growth in commercial volume.

• Drive collection of process requirements from cross-functional stakeholders

• Develop and present updates author protocols reports and SOPs.

• Support a Quality first culture by initiating and supporting the improvement and continuation of initiatives driving accuracy and consistent adherence to regulations.

• Have a change-agent mindset.

Essential Qualifications:

• BS degree in engineering or science preferably in bioengineering chemical engineering molecular biology genetics biochemistry or a related discipline and 5-8 years of related experience. MS with 6 years of related work experience or a PhD with 3 years of related work experience will also be considered.

• Must be able to work cross functionally in teams or with individuals on designated projects to help clients and operators achieve sustainable results.

• Experience in streamlining workflows and developing automated laboratory processes and instrumentation systems including collecting and documenting requirements developing concepts design testing/validation implementing and training

• Experience with standard molecular biology techniques such as nucleic acid isolation purification and quantitation bioanalyzer DNA/RNA quantitation qPCR or next generation sequencing

• Proficient in biological sample handling as needed (i.e. tissue blood biofluid etc.).

• Data analysis visualization and reporting skills utilizing various software applications.

• Excellent written and oral communication skills.

• Highly skilled in visualization tools SharePoint Microsoft Office (Word PowerPoint Excel Visio Project).

• Experience with development under FDA regulated environment is a plus

• Experience with data analysis in JMP R and python is a plus

Hybrid Work Model: This section is applicable to onsite employees who are eligible for hybrid work location as specified by management and related policies. Guardant has defined days for in-person/onsite collaboration and work-from-home days for individual-focused time. All U.S. employees who live within 50 miles of a Guardant facility will be required to be onsite on Mondays Tuesdays and Thursdays. We have found aligning our scheduled in-office days allows our teams to do the best work and creates the focused thinking time our innovative work requires. At Guardant our work model has created flexibility for better work-life balance while keeping teams connected to advance our science for our patients.