Automation Engineer I/II (Contract)

Job description

DELFI Diagnostics, Inc. (DELFI Diagnostics) is developing next-generation, blood-based tests that are reliable, accessible and deliver a new way to help detect cancer. Employing advanced machine-learning methods to whole-genome sequencing data, the DELFI ("DNA EvaLuation of Fragments for early Interception") platform is built to address the highest-burden health challenges. DELFI Diagnostics prioritizes solutions that have the potential to save lives on a global scale, including for historically underserved populations. DELFI Diagnostics’ platform relies on fragmentomics – the discovery that cancer cells are more chaotic than normal cells and, when they die, leave behind tell-tale patterns and characteristics of cell-free DNA (cfDNA) fragments. FirstLook Lung, for individuals eligible for lung cancer screening, is DELFI Diagnostics’ first laboratory-developed screening test and can be part of routine blood work. FirstLook Lung uses millions of data points to reliably identify individuals who may have cancer detected through low-dose CT, including early stage disease with a negative predictive value of 99.8 percent. This test has not been cleared or approved by the FDA. In our passionate pursuit to radically improve health outcomes, we serve humanity when we: - **Lead with Science, Anchor in Pragmatism:** We pioneer life-changing science by ensuring quality, transparency, and rigor at all times. We explore thoughtfully, experiment smartly, and deliver impact with conviction. - **Build With & For All:** We embrace diverse backgrounds to innovate and achieve together. We are not just building a product - we aim to disrupt the path of cancer for all - no matter geography or socioeconomic class - **Put We over I:** We are a home for high-performing people. Through teamwork, we build collective intelligence. Each of us wins when those we serve and those who serve with us--win. We show up with empathy, humility, and integrity at every step of the journey. ### About the role In this role, you will be responsible for supporting high complexity process automation engineering for cancer detection via next generation sequencing. You will be troubleshooting, testing, and verifying automated scripts on liquid handlers. You will work cross-functionally with clinical laboratory scientists, tech transfer scientists, data scientists, software engineers, systems engineers, and quality. This is a critical role that will help bring Delfi’s instrumentation through the development, verification, and validation process and launch them into clinical use. ### What you'll do - Support, maintain, test, and troubleshoot liquid handling platforms (e.g., Hamilton, Tecan, Beckman, or equivalent) used in clinical multi-omics workflows - Perform routine and corrective maintenance on laboratory instruments including liquid handlers, centrifuges, plate sealer, plate peelers, proteomics platforms, thermal cyclers, cold storage units, and related equipment - Monitor and maintain ultra-low temperature (ULT) freezers, refrigerators, to ensure sample integrity and compliance - Coordinate instrument qualification activities (IQ/OQ/PQ) and assist with vendor service scheduling - Rapidly diagnose and resolve instrument failures to minimize impact on clinical workflow timelines - Create, execute, and maintain SOPs, maintenance logs, and equipment records in accordance with CAP, CLIA, and NYS DOH laboratory regulations - Accurately document all troubleshooting activities, corrective actions, and preventive maintenance in the laboratory's quality management system (QMS) - Support gap assessments and readiness activities as the laboratory progresses toward FDA regulation (21 CFR Part 820 / QSR) - Participate in inspections and internal audits; respond to equipment-related observations and corrective action requests - Maintain equipment inventory, calibration schedules, and service records in compliance with regulatory requirements - Collaborate cross-functionally with scientists and lab operations to identify opportunities for process improvement and automation - Support onboarding and training of laboratory staff on instrument operation and maintenance best practices - Assist with reagent and consumable management for instrumentation as needed - Contribute to other laboratory needs as assigned, including assay support, facility tasks, and special projects - Document troubleshooting efforts with root cause analysis and corrective actions under design control and quality management systems, policies and procedures. - Perform basic lab work in support of R&D activities - Own the Equipment Ticketing System, pushing instrument tickets as they progress through support and communicating to ticket owners resolutions and updates. - Update instrument status and maintenance completion in LIMS Sapio. ### What you'll bring **Required** - B.S. or higher in engineering, biology, or similar field providing a strong foundation in lab automation, systems development, and science - High level of analytical ability to solve complex technical problems - Skilled in technical and non-technical communication - Able to master new concepts and skills quickly, with strong attention to detail - Comfortable working in both individual and cross-functional team settings **Level I** - Knowledge of liquid processing equipment and procedures in high-throughput settings - Knowledge in the development of assay automation on liquid handlers (i.e. Hamilton, Agilent, Beckman, Tecan) **Level II** - 3+ years of experience in the development of assay automation on liquid handlers - Proven track record in automating next generation sequencing techniques and procedures in high-throughput settings - Skilled with standard molecular biology and wet lab techniques such as nucleic acid isolation, purification, and quantification - Experience in automation-LIMS integration, designing and executing instrument testing/validation plan **Preferred** - Knowledge in automating next generation sequencing techniques - Experience with Computer Programming and programming concepts - Experience working in a regulated environment (e.g., CLIA, CAP, NYS, FDA, GXP, etc.) - Experience in reagent manufacturing, ideally in a regulated environment (cGMP) - Experience programming automated liquid handlers for NGS assay, Hamilton