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Reagent Manufacturing Engineer II

Company: Guardant Health, Inc.
Location: redwood city
Posted on: May 3, 2021

Job Description:

Company DescriptionGuardant Health is a leading precision oncology company focused on helping conquer cancer globally through use of its proprietary blood tests, vast data sets and advanced analytics. The Guardant Health Oncology Platform leverages capabilities to drive commercial adoption, improve patient clinical outcomes and lower healthcare costs across all stages of the cancer care continuum. Guardant Health has launched liquid biopsy-based Guardant360, Guardant360 CDx and GuardantOMNI tests for advanced stage cancer patients.These tests fuel development of its LUNAR program, which aims to address the needs of early-stage cancer patients with neoadjuvant and adjuvant treatment selection, cancer survivors with surveillance, asymptomatic individuals eligible for cancer screening and individuals at a higher risk for developing cancer with early detection.Job DescriptionAs a Reagent Manufacturing Engineer IIyou'll be responsible to solve medium complexity problems and recommend innovative solutions. You will provide manufacturing technology and robust solutions aimed at commercializing new products and continuously improving production processes.Working cross-functionally with Technical Development teams across the company, as well as with Manufacturing, Quality Control, Clinical Operations, Warehouse and Quality Assurance, you will resolve problems encountered on the production floor or warehouse, and will apply your engineering knowledge and creativity to implement adaptations and modifications to production and to quality systems.You will work with cross functional teams thatexplore, develop, optimize, test, and implement robust, scalable solutions for Guardant Health's Manufacturing Operations with attention to understanding business and user requirements and improving efficiency, throughput, and quality.The successful candidate will apply scientific methods and engineering skills to improve the scalability of Guardant Health's Manufacturing Operations with assistance from Technical Development teams and Operations management.Essential Duties and Responsibilities:Technology TransferAs a point person in leading process and equipment transfer from R into Manufacturing Operations.Provide user requirements to project teams to ensure manufacturability of processes/methods.Develop, refine and release SOPs or Manufacturing Forms from Development team into Manufacturing via Change Control.Manufacturing SupportProvide sustaining support, including troubleshooting, process improvement, and new equipment specifications.Support production by training manufacturing associates and quality control technicians, creating and maintaining product and process documentation, and implementing process improvements that increase yield, efficiency, and/or throughput.Lead/participate in non-conformance investigation and CAPA closure Execute root cause analyses and recommend vetted solutions.Develop KPIs and monitor progress.Collaborate with cross functional teams on label design, Safety Data Sheets and validation activities.Maintain manufacturing processes in validated state.Process Optimization/StandardizationOptimize production processes by designing fixtures, acquiring off-the-shelf tooling and equipment, and implementing new fixturing on the production line.Lead 5S and continuous improvement projects.Coordinate with suppliers and other external resources needed in developing and implementing process improvement plans.QualificationsWhat we are looking for:You must be collaborative and able to effectively participate in cross functional teams working in a variety of projects.You're an engineer with a proven track record of production floor support.You're eager to participate in troubleshooting process problems and developing solutions to resolve/mitigate risks.An interdisciplinary background in molecular biology, lab automation and programming is desirable.The ideal candidate will have prior, demonstrated experience developing, testing, implementing, troubleshooting and supporting kit assembly, liquid dispensing, formulation and/or warehouse automation using a requirements-driven approach in a clinical laboratory or other molecular biology-based laboratory setting.You will also apply engineering, molecular biology, and/or biochemistry knowledge to troubleshoot manufacturing issues.Requirements:A BS degree in engineering or science, preferably in molecular biology, genetics or biochemistry, bioengineering, mechanical/chemical engineering or a closely-related discipline and 2-4 years of related experience. An MS with 1+ years of related work experience will also be considered.Experience in streamlining workflows and developing robust manufacturing processes.Hands-on experience with operating and programming liquid handling robotics platforms. Experience with Hamilton liquid handlers is a plus.Experience with automated development of next-generation sequencing (NGS) assays and/or standard molecular biology techniques such as nucleic acid isolation and purification, DNA quantitation, PCR, etc.Experience working within regulated environments (FDA, IVD, LDT, ISO, etc.) is preferred.Strong communication and collaborative skills, working with internal and external colleagues and customers from diverse scientific, engineering, operational, and regulatory disciplines.Experience with statistical data analysis, monitoring data quality, and troubleshooting technical problems is a plus.Additional InformationWork Environment:Employee may be required to lift routine office supplies and use office equipment. Work might be performed in a production or desk/office environment. 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 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/ #LI-JD1Job Location

Keywords: Guardant Health, Inc., Redwood City , Reagent Manufacturing Engineer II, Other , redwood city, California

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