Process Engineer, Lab Automation & GMP Compliance

Foundation Medicine, Inc.; Morrisville (NC); On-site; USD 81,000 - 104,000; Full time

Job summary

Foundation Medicine, Inc. is seeking a Process Engineer to join the Process Engineering team within Strategic Operations. You will support automated laboratory systems powering the clinical assays and contribute to the optimization of workflows across sites.

Responsibilities include on-site technical support, preventive maintenance, deployment of new protocols, documentation, and collaboration with vendors. Regular onsite work is essential, with potential off-hours and weekend coverage as needed.

Qualifications

• B.S./B.A. in life sciences, biotech, engineering or related discipline.
• 2 years in pharma/biotech lab setting.
• 5+ years with automated lab systems (software and hardware).

Responsibilities

• Provide on-site technical support of automated platforms.
• Perform routine preventative maintenance and coordinate third-party service visits.
• Enhance existing and develop new automated workflows.
• Lead maintenance, metrology and calibration across labs/sites.
• Install, test and control new versions of automated protocols.
• Author technical documents (SOPs, Work Instructions, IQs, OQs, Change Controls).
• Participate in deployment activities to roll out new instrumentation.
• Perform qualification activities on lab automation instruments.
• Report data on platform reliability and downtime.
• Provide training/documentation for end users.
• On-call remote support as needed.
• Comply with FMI attendance policies.

Skills

Lab automation

Teamwork

Documentation

Education

B.S./B.A. in life sciences or related

Tools

Hamilton robot systems

Agilent equipment

Beckman Coulter systems

ServiceNow

Veeva

Git

Confluence

JIRA

SharePoint

VBscript/Python/Perl/JavaScript

SQL/LIMS

Job description

Foundation Medicine, Inc. is seeking a Process Engineer to join the Process Engineering team within Strategic Operations. You will support automated laboratory systems powering the clinical assays and contribute to the optimization of workflows across sites.

Responsibilities include on-site technical support, preventive maintenance, deployment of new protocols, documentation, and collaboration with vendors. Regular onsite work is essential, with potential off-hours and weekend coverage as needed.