Senior Manufacturing Automation Engineer (FDA & Compliance)

Quality Consulting Group, LLC; Juncos (PR); On-site; USD 70,000 - 100,000; Full time

Job summary

Quality Consulting Group, LLC is looking for a skilled engineer to provide full automation support in a pharmaceutical/manufacturing setting in Puerto Rico and the USA. You will optimize systems, upgrade equipment, and ensure adherence to FDA and CGMP standards while supporting maintenance teams and regulatory inspections.

The role requires a Bachelor's in Engineering, 2+ years in automation, and experience with Rockwell PLC and Cognex vision systems.

Qualifications

• Bachelor's degree in Engineering or related field.
• Experience in recipe entry in packaging equipment and automation parameterization.
• 2+ years of Engineering or Automation experience.
• Knowledge on PLC Systems Troubleshooting - Rockwell.
• Knowledge on Vision Systems Troubleshooting/Adjustment - Cognex.
• Knowledge on cGMPs.
• Knowledge on basic control systems hardware.

Responsibilities

• Provide technical engineering support on system/equipment optimization, upgrades, replacements, and modifications to ensure maintenance compliance with corporate, industry, regulatory, and FDA standards.
• Evaluate utility, process, instrumentation/electrical, and technical cleaning systems for regulatory compliance.
• Ensure maintenance team training programs, SOPs, and equipment standards are consistent across the team.
• Coordinate technical support to the maintenance team on engineering, regulatory, calibration, quality, and environmental issues.
• Assist with FDA inspections and respond to regulatory inquiries with technical support.
• Assist with high purity water systems and environmental monitoring notifications.
• Contribute to audits of maintenance activities and documentation for compliance.
• Support engineering improvements, policy changes, and optimization programs.
• Assist with testing of sanitization and maintenance procedure changes.

Skills

Engineering

Automation

PLC Troubleshooting

Rockwell

Cognex Vision

Regulatory cGMP

Control hardware basics

Education

Bachelor's degree in Engineering or related area

Tools

Rockwell PLC

Cognex Vision Systems

Systech System

Job description

Quality Consulting Group, LLC is looking for a skilled engineer to provide full automation support in a pharmaceutical/manufacturing setting in Puerto Rico and the USA. You will optimize systems, upgrade equipment, and ensure adherence to FDA and CGMP standards while supporting maintenance teams and regulatory inspections.

The role requires a Bachelor's in Engineering, 2+ years in automation, and experience with Rockwell PLC and Cognex vision systems.