Lead Automation Engineer, GMP Controls & Lifecycle

Insight Global; United States; On-site; USD 120,000 - 150,000; Full time

Job summary

Insight Global seeks a Senior Automation Engineer to provide technical leadership for GMP manufacturing and facility automation at the Patriot Park site. You will own critical automation and controls infrastructure, ensuring reliability, regulatory compliance, and adherence to engineering standards.

You will support day-to-day operations, troubleshoot complex automation issues, and drive capital projects from design through IQ/OQ/PQ and validation.

Qualifications

• 8+ years of progressive experience in automation, instrumentation, and control systems within a regulated manufacturing environment.
• Bachelor's degree in Engineering or related technical discipline required.
• Experience with FDA-regulated pharmaceutical/biotech manufacturing environments preferred.
• Strong GMP, validation and quality systems knowledge.
• Experience leading automation projects from concept through commissioning and qualification.

Responsibilities

• Serve as technical owner for facility and manufacturing automation systems; ensure reliable and compliant operation.
• Provide advanced troubleshooting for PLC, HMI, SCADA, and networked control systems.
• Lead automation investigations, root cause analyses, and corrective actions for system issues.
• Prepare and review engineering documentation including Change Controls, CAPAs, Deviations, Impact Assessments, and Validation.
• Support regulatory inspections and maintain GMP-compliant automation systems.
• Manage multiple automation projects as Project Engineer or technical lead.
• Oversee full lifecycle activities: design, configuration, implementation, commissioning, qualification, startup.
• Collaborate with operations, facilities, quality, validation, and manufacturing teams and external vendors for safe, compliant projects.
• Identify and implement continuous improvement opportunities to enhance system reliability and efficiency.

Skills

PLC systems

HMI platforms

SCADA applications

Regulatory compliance

GMP awareness

Validation practices

Project management

Cross-functional teamwork

Engineering leadership

Documentation control

Education

Bachelor's degree in Engineering

Tools

Cytiva Unicorn

Rockwell FactoryTalk

Rockwell Studio 5000/RSLogix

OPC

Job description

Insight Global seeks a Senior Automation Engineer to provide technical leadership for GMP manufacturing and facility automation at the Patriot Park site. You will own critical automation and controls infrastructure, ensuring reliability, regulatory compliance, and adherence to engineering standards.

You will support day-to-day operations, troubleshoot complex automation issues, and drive capital projects from design through IQ/OQ/PQ and validation.