Senior Automation Engineer

About the Job

The Senior Automation Engineer is part of the Process Engineering and Laboratory Automation team responsible for developing, deploying, and maintaining automated laboratory systems supporting the clinical assays that will power the future of oncology testing at Foundation Medicine. The scientists and engineers in the group collaborate with project and cross-functional teams in a matrixed organization to continuously improve the efficiency and effectiveness of new products and laboratory processing workflows, as well as implementing automated laboratory systems supporting our Next- Generation Sequencing based diagnostic assays.

The Senior Automation Engineer, Service and Support, ensures productivity in our Automated Clinical Laboratory. The successful candidate will be responsible for continuous development and support of laboratory automation in a complex and rapidly evolving space. The set of instrumentation at our disposal includes but is not limited to liquid handlers, robotic manipulators, bulk reagent dispensers and microplate readers. This person works closely with end users to ensure that the introduction of new or modified automated protocols has as few unforeseen complications as possible. This Senior Automation Engineer also performs routine maintenance as necessary and acts as the primary liaison between Foundation Medicine and support engineers from third-party vendors.

Regular onsite work at a designated FMI location is an essential function of this role.

Key Responsibilities

• Be able to support in design and execution of quality protocols, experiments, and investigations
• Support data analysis for automation experiments and investigation
• 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.

Qualifications

Basic Qualifications

• Bachelor’s Degree in the Life Sciences, Bioengineering or Biotechnology, Engineering, or related disciplines and 4+ years of experience in a pharmaceutical, biotechnology, field service, or diagnostic laboratory setting OR
• M.S in the Life Sciences, Bioengineering or Biotechnology, Engineering, or related disciplines and 2+ years of experience in a pharmaceutical, biotechnology, field service, or diagnostic laboratory setting

Preferred Qualifications

• PhD in the Life Sciences, Bioengineering or Biotechnology, Engineering, or related disciplines
• 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, SharePoint, and IQVIA Pilgrim EQMS
• Previous teaching or technical training experience
• Technical Support and/or Customer Service experience with the associated patience, courtesy and diplomacy
• Knowledge of safety protocols in workshop, factory, or laboratory setting
• Familiarity with VBscript, Python, PERL and/or JavaScript, relational databases, SQL, LIMS or other relevant enterprise software packages
• Ability to document and report troubleshooting procedures and resolutions
• Ability to work as an individual as well as in a team environment
• Strong written and oral communication skills
• Excellent attention to detail with the ability to communicate effectively and work cross-functionally in a matrixed organization
• Flexibility in working late evenings and/or weekend hours
• Understanding of HIPAA and importance of privacy of patient data
• Commitment to FMI values: patients, innovation, collaboration, and passion