Job description

Position Summary

We are seeking a skilled Automation Engineer to join our manufacturing technology team. In this role, you will design, implement, and maintain automated systems that ensure consistent product quality while optimizing production efficiency. You will work at the intersection of engineering, computer science, and life sciences to develop solutions that meet strict regulatory requirements while driving operational excellence.

Key Responsibilities

• Design and implement automation solutions for manufacturing processes, including PLC programming, HMI development, and system integration
• Troubleshoot and optimize existing automated systems to improve efficiency, reduce downtime, and ensure product quality
• Collaborate with cross-functional teams including manufacturing, quality, validation, and IT to develop comprehensive automation strategies
• Ensure all automated systems comply with FDA, ISO, and other regulatory requirements
• Develop technical documentation including requirements, specifications, test protocols, and validation reports
• Support maintenance teams by providing technical expertise and training on automated systems
• Evaluate new automation technologies and recommend implementations to improve production capabilities
• Participate in risk assessments and validation activities for automated equipment

Qualifications

• Bachelor's degree in Electrical Engineering, Computer Engineering, Biomedical Engineering, or related technical field
• 5+ years of experience in industrial automation, preferably in medical device or pharmaceutical manufacturing
• Proficiency in PLC programming (Allen Bradley, Siemens, etc.) and HMI development
• Experience with industrial communication protocols (Ethernet/IP, Profinet, Modbus, etc.)
• Knowledge of FDA regulations (21 CFR Part 820, 21 CFR Part 11) and cGMP requirements
• Understanding of validation methodologies including IQ/OQ/PQ
• Experience with SCADA systems, data acquisition, and manufacturing execution systems
• Strong problem-solving skills and ability to work under pressure in a manufacturing environment

Preferred Skills

• Experience with robotics and vision systems
• Knowledge of batch automation systems and standards (ISA-88)
• Experience with serialization and track-and-trace systems
• Familiarity with clean room manufacturing environments
• Project management experience
• Six Sigma or Lean Manufacturing certifications

What We Offer

• Competitive salary and comprehensive benefits package
• Opportunity to work on critical healthcare technologies that improve patient lives
• Professional development and continuous learning opportunities
• Collaborative and innovative work environment
• Career advancement path in a growing industry