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Senior Service and Applications Engineer at Genomic Health
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Senior Service and Applications Engineer

Apply Share Job ID 1093 Category Laboratory Operations Job Location Redwood City, California Posted Date 10/16/2018

Overview:

As a member of our Service & Applications Engineering team, this Engineer is responsible for service and applications support of complex robotic workstations, qPCR instruments, as well as other laboratory equipment. He or she will conduct preventative maintenance and troubleshoot instrument problems by performing root cause analysis, implementing and documenting appropriate corrective actions, while maintaining instruments to peak performance for Genomic Health's various laboratory environments. These environments include the Clinical Laboratory where our industry-leading Oncotype DX® clinical diagnostic assays are run, the R&D laboratories where new product concepts are developed, and our Manufacturing and QC laboratories, which provide high-quality reagents for use in the other lab functions within Genomic Health.
The successful candidate will have hands-on experience with liquid handling robotics and an in-depth understanding of current laboratory instruments used for nucleic acid isolation, quantification, and downstream analysis using quantitative RT-PCR. Activities will include responding to instrument related errors, performing root cause analysis to identify the problem, and implementing an appropriate corrective action to repair the instrument in a time-critical customer service oriented manner. He or she will be expected to develop a working knowledge of all Genomic Health laboratory processes and associated systems such as our Laboratory Information Management Systems (LIMS).

This Service Engineer will participate in cross-functional teams working in a variety of areas. These efforts will require excellent communication and collaboration with colleagues in Process Engineering, Assay Chemistry, our Clinical and Development Laboratories, Program Management, Research, Analytical Sciences, Manufacturing, Quality Assurance, and other groups.

The ideal candidate will be working cooperatively in a dynamic and interdisciplinary laboratory environment, adapting quickly to change and new technical challenges while providing strong technical leadership. This is an excellent opportunity for a team player to participate in the growth of a fast-paced, pioneering company that is developing systematic approaches to applying genomic technology to health, disease, and medical practice.

The position will report to the Service Engineering Manager within the Service Engineering Group organization.

RESPONSIBILITIES / DUTIES:

- Work cooperatively with teammates and other cross-functional groups to ensure
continued operation and maintenance of commercial processes within the
Analytical, Clinical Sequencing, Genomic Sciences, and Manufacturing laboratories.

- Troubleshoot, diagnose and resolve complex hardware and software issues of
robotic workstations, qPCR instruments, and other laboratory equipment utilizing
root cause analysis methodologies.

- Performing Installation Qualification (IQ), Operational Qualification (OQ), and
Process Qualification (PQ), functional and verification testing on laboratory
equipment as required in accordance with quality requirements.

- Performing equipment Preventative Maintenance and/or Calibrations as required
in accordance with quality requirements.

- Serve as subject matter expert on highly complex automated laboratory systems
and operational processes, and as such will assist in defining support and servicing
processes, operational policies, and quality requirements.

- Serve as a technical representative with external groups (other GHI engineering
groups and end users) to provide sustaining and service engineering perspectives
and expertise as it pertains to the development of novel workflows and/or process
improvements.

- Assist with performing administrative and technical reviews of service
documentation to ensure completeness and accuracy in accordance with GHI's
Quality Management System.

- Write, review, and revise detailed technical IOOQPQ documents, Standard
Operating Procedures, and Work-notes incorporating input from other groups
efficiently and effectively.

- Engage junior service engineers by mentoring on best practices in processes,
sustaining engineering, and quality.

- Participate and contribute to developing subject matter experts via knowledge
transfer through example and hands-on training.

- Assist with directing junior team members and support staff with daily scheduling, operational tasks, and training.

- Support the best principles of Clinical Laboratory Improvement Amendments (CLIA), Good Laboratory and Clinical Practices (GLP/GCP) and ISO 13485 as it pertains to installation and servicing provisions.

- Participate in 24/7 week-long Service Engineering on-call rotation with other team members.

- Other duties as assigned.

- The role is an Individual Contributor

QUALIFICATIONS

Required:

- B.S. in a relevant scientific or engineering discipline.
- At least 4 years of relevant experience in use and support of automated laboratory equipment.
- Experience with automated liquid handling instrumentation (Tecan, Hamilton, or other)
- Demonstrated electromechanical aptitude relevant to automated liquid handlers and other general laboratory equipment.
- Capability to drive professional development by mastering instrument and assay related troubleshooting, preventative maintenance, and qualification procedures, exhibiting attention to detail and robust problem-solving skills.
-Experience with standard molecular biology techniques such as nucleic acid isolation, RNA/DNA quantification, PCR, and RT-PCR.
- Experience with Quality Systems and documentation requirements.
- Competent in writing or revising detailed Standard Operating Procedures for processes performed by the Service Engineering Group
- Ability to maintain flexibility and prioritize work schedule to support instrument up-time and sample throughput
- Ability to quickly adapt and apply new methods and technologies
- Working knowledge of database, laboratory information management systems, and other file management applications.
- Excellent interpersonal and communication skills (both written and verbal) and the ability to maintain open communication with internal employees, managers, and customers as needed.
- Able to integrate and apply feedback in a professional manner.
-Able to prioritize and drive to results with a high emphasis on quality.
- Maintain positive customer and service-oriented interactions with customers and colleagues.
- Ability to work as part of a team.

Desired:

- Experience operating a variety of liquid handling robotics platforms.
- Knowledge of TECAN EVOware and/or Hamilton Venus scripting languages.
- Ability to perform laboratory activities including nucleic acid extraction, reverse transcription, quantitative PCR and next-generation sequencing utilizing various technologies
- Experience with ISO 13485, ISO 9001, and 21 CFR 820 quality systems
- Experience with using Laboratory Information Management Systems (LIMS)

Advertisement:

The Service & Applications Engineer is responsible for service and applications support of complex robotic workstations, qPCR instruments, as well as other laboratory equipment. Will conduct preventative maintenance and troubleshoot instrument problems by performing root cause analysis, implementing and documenting appropriate corrective actions, while maintaining instruments at peak performance.
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If you want to be part of a team that prides itself in teamwork and developing cutting-edge technology at Genomic Health, apply today!