Sr/Principal Automation Engineer

Key Responsibilities

• Analyze existing machine/system issues and identify underlying design and validation gaps
• Evaluate, troubleshoot and rewrite existing PLC/HMI code, to ensure that it aligns with revised design and testing documentation.

Required Qualifications

• Demonstrated experience supporting validated machine integration for FDA regulated Medtech or Life Science industry
• Extensive experience with IQ/OQ/PQ execution and remediation, CSV and validation documentation
• Automation system troubleshooting and root cause analysis, PLC code modification and system redesign
• Ability to reverse engineer existing systems and identify design deficiencies, experience working directly with OEMs/vendors during remediation projects, strong onsite troubleshooting and stakeholder communication skills
• Experience supporting commissioning/startup activities

Preferred Qualifications

• Ignition experience is highly desirable, though not essential
• Familiarity with MES or SCADA integration
• Previous remediation or recovery project experience