Reagent Manufacturing Engineer II

Reagent Manufacturing Engineer II

Vacancy expired!

Job Description

As a

Reagent Manufacturing Engineer II, you will be responsible to solve complex problems and implement innovative solutions. You will provide manufacturing technology and robust solutions aimed at commercializing new products and continuously improving production processes. Working cross-functionally with internal engineering groups,Production, Quality Control and Quality Assurance, you will resolve problems encountered on the production floor, and will apply your engineering knowledge and creativity to implement adaptations and modifications to production and quality systems.

You will be a key contributor to internal cross-functional project teams. Theseteams will explore, 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.

TheReagent Manufacturing Engineer II appliesscientific methods and engineering skills to improve the scalability of Guardant Health’s Manufacturing Operations.

Essential Duties and Responsibilities:

• Optimize production processes by designing fixtures, acquiring off-the-shelf tooling and equipment, and implementing new fixturing on the production line.
• Assist in non-conformance investigation and CAPA closure.
• Execute detailed root cause analyses and recommend vetted solutions.
• 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.
• As a point person in leading process and equipment transfer from R&D into Manufacturing Operations.
• Develop, refine and release SOPs or forms from Development team into Manufacturing via Change Control.
• Provide user requirements to project teams to ensure manufacturability of processes/methods.
• Develop, characterize, and optimize processes using statistical techniques and engineering knowledge and experience.
• Coordinate with suppliers and other external resources needed in developing and implementing process improvement plans.
• Participate in project planning and scheduling.
• Provide sustaining support, including troubleshooting, process improvement, and new equipment specifications.
• Develop KPIs and monitor progress.
• Lead 5S and continuous improvement projects.
• Collaborate with cross functional teams on label design, Safety Data Sheets and validation activities.
• Maintain manufacturing processes in validated state.

Qualifications

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. You are willing to work for a high growth and fast paced startup. An interdisciplinary background in molecular biology, lab automation and programming is desirable. The ideal candidate will havedemonstrated 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. He or she will also apply engineering, molecular biology, and/or biochemistry knowledge to troubleshoot manufacturing issues.

You also have:

• A BS degree in engineering,molecular biology, genetics,biochemistry, bio-engineering, or a closely related discipline and 3-5 years of related experience. An MS degree with at least 2years of relevantwork 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 NGSassays and/or experience with standard molecular biology techniques such as nucleic acid isolation and purification, DNA quantitation, PCR, etc
• Experience workingina clinically regulatedenvironment is required(FDA, IVD, LDT, ISO, etc.)
• Strong communication skills, experienceworking with internal and external colleagues and customers from diverse scientific, engineering, operational, and regulatory disciplines.
• Experience working independently and as part of a team
• Experience with statistical data analysis, monitoring data quality, and troubleshooting technical problems.

Work 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.

Additional Information

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.

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

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