Senior Metrology Specialist

Company Description

Guardant Health is a leading precision oncology company focused on helping conquer cancer globally through use of its proprietary 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 commercially launched Guardant360®, Guardant360 CDx, Guardant360 TissueNext™, Guardant360 Response™, and GuardantOMNI® tests for advanced stage cancer patients, and Guardant Reveal™ for early-stage cancer patients. The Guardant Health screening portfolio, including the Shield™ test, aims to address the needs of individuals eligible for cancer screening.

Job Description

About the Role 

As part of the Service Engineering organization, the Sr. Metrology Specialist is responsible for the oversight, calibration, maintenance, and repair of analytical and microbiology equipment. The Sr Metrology Specialist must also be sensitive to the demanding regulatory compliance requirements applicable to the operation of a pharmaceutical testing laboratory.

Essential Duties and Responsibilities:

• Perform instrument IQ/OQ/PQ, PMs, calibrations, and repairs to ensure that instruments meet Guardant Health’s quality system requirements
• Proficient in the use of CMMS (Computerized Maintenance Management System) for calibration software data entry, records maintenance, report generation, and other related required documentation
• Communicate with labs to coordinate installation, and calibration/preventative maintenance tasks
• Evaluate equipment for fitness of use and verification of performance within specified parameters per established calibration procedures
• Ensure proper documentation following GDP
• Perform testing and adjustments using SOPS/WIs or technical experience when no procedure is available.
• Effectively communicate with third-party service providers to coordinate service and warranty repairs
• Organize and execute equipment moves and recalibrations as needed
• Ensure necessary supplies and equipment are ready and available
• Provide input for creating calibration and verification methods, creating/revising SOPs and Work Instructions
• Perform other duties and responsibilities as assigned
• Assist in developing and/or improving current processes

Qualifications

• Associate’s degree (AA/AS) in a scientific, mechanical or related field of study with 3-5+ years of calibration and technical service experience, or an equivalent combination of education, training, and/or experience.
• Excellent working experience with a CMMS; working knowledge of Qualer is a plus.
• Experience authoring and executing calibrations, preventative maintenance, repair work, and other service-related work and documentation.
• Familiar with a variety of hand tools, electric meters, calibration standards to perform essential day-to-day duties.
• Working knowledge of Viewpoint or similar environmental monitoring systems
• Adaptability to fast pace changing environment.
• Basic troubleshooting skills relating to cold storage and other ancillary equipment.
• Experience applying 5S, Lean Manufacturing methodologies.
• Ability to effectively communicate and collaborate in-person or via email with internal and external customers from diverse scientific, engineering, operational, and regulatory disciplines.
• Demonstrated independent and self-motivated professional with the capability to handle several tasks with minimal supervision.
• Ability to take part in an on-call rotation with afterhours/weekend response as needed.
• Willingness to travel up to 30% as needed.

Physical Requirements

• Employee may frequently exert up to 20-50 pounds of force to push or lift equipment
• This position requires standing/walking/crawling regularly

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 hourly range for this full-time position is $40.38 to $54.80. The range does not include