About the Job
The Automation Engineer is part of the Process Engineering and Laboratory Automation team responsible for developing, installing, and maintaining automated laboratory systems supporting the clinical assays that will power the future of oncology testing through Comprehensive Genomic Profiling at Foundation Medicine. The scientists and engineers in the group collaborate with project and cross-functional teams in a matrix organization to continuously improve the efficiency and effectiveness of our new and existing automated laboratory products and processes.
The Automation Engineer, Service and Support, drives operational productivity in our automated and regulated clinical laboratories. The incumbent is responsible for continuous support and improvement of complex laboratory automation in a dynamic environment. The set of instrumentation at our disposal includes but is not limited to liquid handlers, robotic manipulators, bulk reagent dispensers, and micro-plate readers. This person works closely with end users to ensure that the introduction of new or updated automated protocols meet the needs of our stakeholders. The Automation Engineer also performs routine maintenance as necessary and acts as the primary liaison between Foundation Medicine and support engineers from third-party vendors.
This is a regulated position and additional information may be available from QA on the qualifications for this role pertaining to regulatory guidelines.
Regular onsite work at a designated FMI location is an essential function of this role.
• Provide on-site technical support of automated platforms.
• Perform routine preventative maintenance on automated instrumentation, as well as coordinate service visits from third-party support engineers as needed.
• Enhance existing and develop new automated workflows.
• Lead maintenance, metrology, and calibration efforts for the laboratory, including planned and unplanned maintenance.
• Install, test, and control new versions of automated protocols on applicable instrumentation across labs and across sites as necessary.
• Provide training and documentation for new or modified workflows to end users.
• Author technical documents: SOPs, Work Instructions, IQs, OQs, Change Controls.
• Perform qualification activities on lab automation instruments.
• Participate in deployment activities to roll out new instrumentation and processes to clinical laboratories.
• Collect, collate, and report on data pertaining to platform reliability and instrument downtime. Monitor instrument performance and suggest efficiency improvements.
• Perform the above responsibilities during normal assigned working hours with flexibility to work off-hours and/or weekend hours as needed based on vagaries in lab schedule and end-user demands. Off-hours remote support on a rotating on-call basis.
• Other duties as periodically assigned.
• B.S. or B.A. in the life sciences, bioengineering or biotechnology, engineering, or related disciplines.
• 2 years of experience, respectively, in a pharmaceutical, biotechnology, field service, or diagnostic laboratory setting
• 5+ years of experience working with automated laboratory systems (software and hardware) in a life sciences, bioengineering or biotechnology, pharmaceutical, engineering, field service, or diagnostic laboratory setting
• Experience with robotic liquid handlers, lab automation, and/or instrumentation (especially from Hamilton, Agilent Technologies, or Beckman Coulter). Experience with automated equipment in bioprocess, fabrication, manufacturing or other industries with high quality standards is also acceptable
• Experience working in a regulated environment (e.g. FDA, QSR, EU, CLIA, CAP, GxP, ISO, etc.)
• Experience in using enterprise level software systems including IBM Maximo, MasterControl, Git, Confluence, JIRA, and SharePoint
• Knowledge of safety protocols in workshop, factory, or laboratory setting
• Technical support and/or customer service experience with the associated patience, courtesy, and diplomacy
• Previous teaching or technical training experience
• Ability to document and report troubleshooting procedures and resolutions
• Ability to work as an individual as well as in a team environment
• Excellent attention to detail with the ability to communicate effectively and work cross-functionally in a matrixed organization
• Strong written and oral communication skills
• Understanding of HIPAA and the importance of patient data privacy
• Commitment to reflect FMI's values: patients, passion, innovation, and collaboration
#LI-Remote [Morrisville, North Carolina, United States]
Confidence, or the belief that we need to check every box before applying for a job, can sometimes hold us back from going after a role that inspires us. At Foundation Medicine there's no such thing as the 'perfect' applicant, and our company is a place where every employee can make an impact and continue to grow whatever background they may have or path they may have taken. So, as long as you meet the basic qualifications for a role, please apply if you see a position that would make you excited to come into Foundation Medicine every day and help us transform cancer care.
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Foundation Medicine is proud to be an Equal Opportunity and Affirmative Action employer and considers all qualified applicants for employment without regard to race, color, religion, sex, gender, sexual orientation, gender identity, ancestry, age, or national origin. Further, qualified applicants will not be discriminated against on the basis of disability or protected veteran status. We also consider qualified applicants regardless of criminal histories, consistent with legal requirements. See also FMI’s EEO Statement and EEO is the Law and Supplement. If you have a disability or special need that requires accommodation, please let us know by completing this form. (EOE/AAP Employer)
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