Reagent Manufacturing Engineer II

Job Description

In this role, you’ll 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 engineering groups across the company, as well as with 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 to quality systems.

You must be collaborative and able to effectively participate in cross functional teams working in a variety of projects.

These cross functional teams 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.

The successful candidate will apply scientific 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 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.

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 or science, preferably in molecular biology, genetics or biochemistry, bioengineering, mechanical / chemical engineering or a closely-related discipline and 3-5 years of related experience.

An MS with 2+ 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 required.
• 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.

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 for this full-time position is $84,000 to $114,000 .

The range does not include benefits and, if applicable, overtime, 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.