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Sr. Automation Service Engineer (Tues-Sat, 3rd shift)
Personalisinc
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About this role
Personalis, Inc. is a leader in advanced cancer genomics for enabling the next generation of precision cancer therapies and diagnostics. The Personalis NeXT Platform® is designed to adapt to the complex and evolving understanding of cancer, providing its biopharmaceutical customers and clinicians with information on all of the approximately 20,000 human genes, together with the immune system, from a single tissue sample. In population sequencing, Personalis operates one of the largest sequencing operations globally and is currently the sole sequencing provider to Veterans Affairs' Million Veteran Program. To enable cancer and population sequencing, Personalis' Clinical Laboratory was built with a focus on clinical accuracy, quality, big data, scale and efficiency. The laboratory is GxP-aligned as well as Clinical Laboratory Improvement Amendments of 1988-certified and College of American Pathologists-accredited. Personalis is based in Fremont, California.
Summary:
The Sr. Automation Service Engineer within the Research, Product Development and Technology Transfer Group will be responsible for site-wide support, service, and maintenance of laboratory instruments used in clinical operations activities. This will include the installation, configuration, repair, calibration, and maintenance of equipment, integrating equipment with information systems and automated systems, and calibration, validation, and verification of equipment in accordance with CLIA, CAPand/or GCLP guidelines. This position will be expected to work in close collaboration with the Operations, Quality, Research, Product Development, Tech Transfer, and Facilities teams. The Automation Service Engineer must be detail-oriented and have strong troubleshooting, documentation and interpersonal skills are essential for success in this position.
Onsite: Tues - Sat, 10pm - 6:30am (3rd Shift)
Responsibilities:
• Be the first line of contact for equipment support and communicate with lab users and the process development teams to solve instrumentation-related problems and issues.
• Perform maintenance, troubleshooting and repair on general laboratory equipment and automated laboratory equipment such as the Hamilton STAR and Hamilton Verso.
• Build rapport with end-users, lab supervisors, and process owners to ensure successful support and growth of the Equipment and Operations teams.
• Perform routine calibration and preventive maintenance on laboratory equipment based on their interval
• Maintain calibration and maintenance records and ensure that documentation is complete and follows Good Documentation Practices (GDP)
• Plan and execute preventive maintenance, instruments service, repairs, and qualifications.
• Author and execute qualification reports (IQ/OQ/PQ) and maintain Preventative Maintenance records.
• Monitor PM schedule to ensure necessary equipment is properly calibrated/PM’ed in a timely manner
• Ability to quickly learn new technologies and distribute information by developing SOPs, and checklists, and updating internal knowledgebase.
• Establish service level objectives and Up-Time metrics.
• Support the Process Development activities with the qualification of new or revised processes and systems.
• Recommend and implement changes to ensure ongoing high-quality performance of laboratory equipment
• Work closely with QA and Operations teams to define QC routines.
• Train Operations technicians on conducting routine activities or basic troubleshooting.
• Provide support for NCR’s and CAPA’s that are automation and equipment related.
• Coordinate duties with other Automation Service Engineers.
• Perform other duties as assigned
Requirements:
• A BS degree in an engineering or related discipline, with minimum 5 years of industry experience.
• Extensive experience in providing service and support for life science industry equipment including the Hamilton Robotics or similar liquid handlers, as well as other integrated robotic systems, analytical and process instruments.
• Experience in performing Hamilton STAR PM, servicing Hamilton Verso, and performing metrology and calibration activities.
• Experience working in a regulated environment (ISO 13485 and CLIA/CAP) is desirable.
• Ability to effectively communicate and collaborate with internal and external colleagues and customers from diverse scientific, engineering, operational, and regulatory disciplines.
• Ability to take part in an on-call rotation with after-hours and weekend response as needed.
• Demonstrate strong independent thinking and decision making skills.
• Good organizational, written, and verbal communication skills.
• An analytical mindset focused on process engineering and process improvement
The hiring range for this position is $120,000 to $150,000 per year, which may factor in various geographic regions. This shift is eligible for an additional shift premium. The base pay actually offered will take into account internal equity and also may vary depending on the candidate’s geographic region, job-related knowledge, skills, and experience among other factors. Our full-time regular positions also include an annual performance-based bonus (or a sales incentive plan) and long-term incentive units (equity) provided as part of our compensation package, in addition to a full range of medical, financial, and/or other benefits, dependent on the level and position offered.
Personalis is an equal opportunity employer and is committed to the full inclusion of all individuals. As part of this commitment, Personalis will ensure that persons with disabilities are provided with reasonable accommodations. If you need an accommodation to participate in the job application or interview process, to perform essential job functions, and/or to receive other benefits and privileges of employment, please let your recruiter know, if/when they contacts you.
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