Job Title: Sr. Manufacturing Automation Engineer
Location: Westbrook, Maine
Schedule: Mon–Fri | 8:00 AM – 5:00 PM
Job Summary
Seeking a Senior Manufacturing Automation Engineer to support automation systems, manufacturing processes, and continuous improvement initiatives in a regulated environment. This role focuses on equipment optimization, troubleshooting, validation, and compliance with cGMP, FDA, and ISO standards.
Key Responsibilities
- Lead automation equipment selection, installation, and upgrades
- Troubleshoot PLC/machine logic, electromechanical systems, and process controls
- Drive root cause analysis (RCA) and implement corrective actions
- Perform FMEA and risk assessments
- Execute DOE, validation, and data analysis
- Improve manufacturing processes for quality, efficiency, and cost reduction
- Develop and maintain SOPs, validation protocols, and technical documentation
- Lead cross-functional projects and coordinate with PMO
- Support CAPA investigations and quality events
- Mentor engineers/technicians and provide technical guidance
- Ensure compliance with FDA, cGMP, ISO 13485
Required Qualifications
- Bachelor’s degree in Engineering
- 7+ years in manufacturing/automation engineering
- Experience with automation equipment and process controls
- Strong knowledge of Lean Six Sigma / DMAIC
- Experience with change management
Preferred Qualifications
- Experience in medical device, pharma, or regulated industries
- Knowledge of cGMP, FDA, ISO 13485
- Experience with statistical tools/software
- Proficiency in Excel, PowerPoint, Power BI
