Process Engineer in Morrisville, North Carolina at Foundation Medicine, Inc.

About the Job:

The Process Engineer is part of the Process Engineering team within the Strategic Operations department responsible for developing, installing and maintaining automated laboratory systems supporting the clinical assays that will power the future of oncology testing and other diseases 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 Process Engineer drives operational productivity in our automated and regulated clinical laboratories. The incumbent is responsible for continuous support 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 Process Engineer performs routine maintenance as necessary and acts as the primary liaison between Foundation Medicine and support engineers from third-party vendors. The Process Engineering position requires working in a lab environment in the presence of chemicals and reagents.

Regular onsite work is an essential function in this role.

Key Responsibilities:

• 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
• Author technical documents (e.g. SOPs, Work Instructions, IQs, OQs, Change Controls)
• Participate in deployment activities to roll out new instrumentation and processes to clinical laboratories
• Perform qualification activities on lab automation instruments
• Collect, collate, and report on data pertaining to platform reliability and instrument downtime
• Provide training and documentation for new or modified workflows to end users
• 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 demand
• Off-hours remote support on a rotating on-call basis
• Other duties as periodically assigned
• Comply with FMI's attendance policies

Qualifications:

Basic Qualifications:

• B.S. or B.A. in the life sciences, bioengineering or biotechnology, engineering, or related disciplines
• 2 years of experience 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

Preferred Qualifications:

• 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 ServiceNow, Veeva, Git, Confluence, JIRA, and SharePoint
• Familiarity with VBscript, Python, PERL and/or JavaScript, relational databases, SQL, LIMS or other relevant enterprise software packages
• 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
• Understanding of HIPAA and the importance of patient data privacy
• Commitment to reflect FMIs values: Integrity, Courage, and Passion

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