Principal Automation Engineer

Principal Automation Engineer

We are seeking a highly skilled Automation Engineer with deep Rockwell PLC expertise to support a critical remediation and validation recovery project for a MedTech manufacturing client in Dallas/Worth, TX area. This role is focused on troubleshooting and correcting a recently installed machine/system where the original validation and documentation work was improperly executed. The successful consultant will work backwards from current operational issues, identify root causes in the original design and validation approach, and lead remediation efforts across controls, software, and validation documentation. The ideal candidate is a senior-level engineer capable of independently analyzing complex automation systems, collaborating with vendors, and driving technical resolution in a regulated manufacturing environment. Determine what should have originally been tested and validated and rewrite and correct validation documentation to align with proper system design intent. Modify and correct PLC/HMI code as required. Collaborate closely with the OEM/vendor responsible for building and installing the system. Support troubleshooting and stabilization efforts for production equipment currently experiencing operational issues. Work cross-functionally with validation and CSV documentation resources and ensure all remediation activities align with regulated industry standards and best practices.

Key Responsibilities:

• Analyze existing machine/system issues and identify underlying design and validation gaps
• Software Design Specifications (SDS), Functional/design documentation, IQ/OQ/PQ documentation, Validation test strategies and execution to execute properly validated machine automation
• Evaluate, troubleshoot and rewrite existing PLC/HMI code, to ensure that it aligns with revised design and testing documentation.

Required Qualifications:

• Bachelor's degree in Engineering, Manufacturing, Industrial Technology, or a related field
• Demonstrated experience supporting validated machine integration for FDA regulated Medtech or Life Science industry
• Strong background in regulated manufacturing environments, ideally Medtech or Pharmaceutical
• 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