Senior Manufacturing Systems Associate - Automation & Quality

Quality Consulting Group, LLC

Juncos (PR)

On-site

USD 85,000 - 105,000

Full time

2 days ago

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Job summary

Quality Consulting Group, LLC seeks a driven Automation/Engineering professional to join our team in Puerto Rico & USA. You will support system optimization, upgrade and maintenance, ensuring adherence to FDA and industry standards in a world-class manufacturing context.

Responsibilities include coordinating technical support, assisting during regulatory inspections, and developing an audit program for maintenance activities. A Bachelor’s in Engineering plus 2+ years experience are required.

Qualifications

Bachelor's degree in Engineering or related area.
Experience in recipe entry in packaging equipment, automation assessment to determine the correct parameter for the recipe and experience in Systech System.
2+ years of Engineering or Automation experience.
Knowledge on PLC Systems Troubleshooting– Rockwell.
Knowledge on Vision Systems Troubleshooting/Adjustment– Cognex.
Knowledge on cGMP’s.
Knowledge on basic control systems hardware.

Responsibilities

Full Automation role will provide technical engineering support on system/equipment optimization strategies, upgrades, replacements, and modifications and ensure compliance with corporate policies, industry standards, regulatory standards and FDA standards.
Evaluate utility systems, process maintenance, instrumentation/calibration/electrical systems and technical cleaning systems for compliance with industry and FDA standards.
Ensure the maintenance team training program, SOPs and equipment/operational standards are consistent.
Coordinate technical support to the maintenance team on engineering, regulatory, calibration, quality, environmental, validation and process maintenance issues.
Assist the maintenance team during FDA and other regulatory inspections and provide technical support.
Assist with investigations on alert/action notifications and environmental monitoring.
Develop and maintain an audit program for the maintenance team and conduct routine audits.
Assist plant engineering with engineering improvements, policy changes and optimization programs.
Assist with testing of proposed sanitization and maintenance procedure changes for process, utility and clean room systems.