Sr. Process Engineer - Hybrid

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, visit guardanthealth.com and follow the company on LinkedIn, X (Twitter) and Facebook.

Job Description

We are seeking a highly motivated Senior Process Engineer to support the development, optimization, and scaling of precision IVD & LDT oncology tests within our Oncology Operations team. This role will be instrumental in driving process improvements, ensuring compliance with regulatory standards, and collaborating cross-functionally with R&D, Quality, and Manufacturing to bring reliable and robust diagnostic solutions to the production lab. 
 
Key Responsibilities: 
• Lead process design, development, and optimization for LDT workflows, including sample prep, reagent handling, automation integration, and assay performance. 
• Act as a technical liaison between R&D and Operations to ensure smooth technology transfer from pilot to full-scale production. 
• Support validation activities including process qualifications (IQ/OQ/PQ), method validations, and equipment validations in accordance with CLIA, CAP, and FDA guidelines. 
• Develop and maintain process documentation including SOPs, batch records, protocols, and engineering reports. 
• Drive root cause analysis and implement corrective/preventive actions (CAPAs) for process deviations and non-conformances. 
• Collaborate with Quality Assurance and Regulatory Affairs to support audits, inspections, and continuous improvement initiatives. 
• Utilize statistical tools and data analysis (e.g., DOE, SPC, Six Sigma) to monitor process performance and identify opportunities for efficiency gains and cost reduction. 
• Support onboarding and training of junior engineers or technical staff as needed. 
 

Qualifications

• Bachelor’s or Master’s degree in Chemical Engineering, Biomedical Engineering, Biotech, or related field. 
• 5+ years of experience in a regulated diagnostics or biomanufacturing environment, with at least 2 years specifically supporting LDTs or clinical lab workflows. 
• Strong knowledge of CLIA/CAP requirements and experience with quality systems and GMP/GLP. 
• Hands-on experience with lab automation platforms, liquid handling systems, and analytical instrumentation used in molecular diagnostics. 

• Strong Hamilton STAR method coding experience, with an emphasis on error handling and troubleshooting 
• Demonstrated success leading cross-functional process improvement or technology transfer projects. 
• Proficiency in data analysis software (e.g., JMP, Minitab, Python, or Excel-based tools). 
• Excellent problem-solving, communication, and project management skills.

Preferred Qualifications: 
• Experience with nucleic acid extraction, PCR, or NGS workflows. 
• Lean Six Sigma certification (Green or Black Belt). 
• Familiarity with ISO 13485 and 21 CFR Part 820. 

Additional Information

Hybrid Work Model: At Guardant Health, we have 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.

For positions based in Palo Alto, CA or Redwood City, CA, the base salary range for this full-time position is $118,400 to $162,800. The range does not include benefits, and if applicable, bonus, commission, or equity.

Within the range, individual pay is determined by work location and additional factors, including, but not limited to, job-related skills, experience, and relevant education or training. If you are selected to move forward, the recruiting team will provide details specific to the factors above.

Employee may be required to lift routine office supplies and use office equipment. Majority of the work is performed in a desk/office environment; however, there may be exposure to high noise levels, fumes, and biohazard material in the laboratory environment. Ability to sit for extended periods of time.

Guardant Health is committed to providing reasonable accommodations in our hiring processes for candidates with disabilities, long-term conditions, mental health conditions, or sincerely held religious beliefs. If you need support, please reach out to [email protected]

Guardant Health is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or protected veteran status and will not be discriminated against on the basis of disability.

All your information will be kept confidential according to EEO guidelines.

To learn more about the information collected when you apply for a position at Guardant Health, Inc. and how it is used, please review our Privacy Notice for Job Applicants.

Please visit our career page at: http://www.guardanthealth.com/jobs/