Sr. Process Engineer - Hybrid
Sr. Process Engineer - Hybrid
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Salary Not Disclosed
1 Vacancy
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 crossfunctionally 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 fullscale 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 nonconformances.
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 :
Bachelors or Masters 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.
Handson 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 crossfunctional process improvement or technology transfer projects.
Proficiency in data analysis software (e.g. JMP Minitab Python or Excelbased tools).
Excellent problemsolving 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 inperson/onsite collaboration and workfromhome days for individualfocused 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 inoffice 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 worklife 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 fulltime position is $118400 to $162800. 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 jobrelated 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 longterm conditions mental health conditions or sincerely held religious beliefs. If you need support please reach out to
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: Work :
No
Employment Type :
Fulltime
Employment Type
Full-time
