Manufacturing Automation Engineer

Senior Manufacturing Automation Engineer
Location: Westbrook, ME
Contract: 12 Months
Schedule: Monday Friday, 8:00 AM 5:00 PM




Pay: 45-52/hr on W2 DOE







Job Summary

We are seeking a Senior Manufacturing Automation Engineer to support manufacturing processes, automation, equipment improvements, quality initiatives, and cost-saving projects within a cGMP/FDA/ISO-regulated environment .

Key Responsibilities

• Lead manufacturing automation and equipment engineering projects.
• Specify, acquire, install, and implement manufacturing equipment.
• Troubleshoot machine logic, electromechanical systems, process controls, and drives.
• Lead equipment upgrades, continuous improvement, and process optimization.
• Perform Root Cause Analysis, FMEA, CAPA, and structured problem solving.
• Lead DOE, validation, testing, and data analysis activities.
• Develop and maintain SOPs, specifications, validation protocols, risk assessments, and technical documentation.
• Lead and mentor engineers and technicians.
• Manage cross-functional projects, timelines, and deliverables.
• Support process development, tooling, characterization, and validation.
• Ensure compliance with FDA, cGMP, ISO, safety, and quality requirements.

Required Qualifications

• Bachelor s degree in Engineering or equivalent experience.
• 5+ years of engineering experience in a manufacturing environment.
• Experience with Lean Six Sigma/DMAIC or similar structured problem-solving methods.
• Strong experience with manufacturing automation, equipment troubleshooting, and process improvement.
• Experience with CAD and manufacturing system layouts .
• Knowledge of fabrication processes including CNC, machining, welding, and bolted connections .

Preferred Qualifications

• Experience in FDA, cGMP, GMP, ISO, or ISO 13485 regulated environments.
• Medical device, pharmaceutical, diagnostics, or other regulated manufacturing experience.
• Experience with statistical analysis software, Excel, PowerPoint, and Power BI .
• Experience with validation, risk management, CAPA, and quality systems.

Interview: Microsoft Teams video interview