JT751 - SR. ASSOCIATE MANUFACTURING SYSTEMS

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, a leader inthe pharmaceutical, biotech, medical devices, and manufacturing industry, is looking for a talented, highly motivated and enthusiastic to join our team. In this role, you’ll work with a highly enthusiastic team, contributing in a world-class manufacturing industry in Puerto Rico & USA.

Responsibilities:

• Full Automation role will provide technical engineering support on all system/equipment optimization strategies, upgrades, replacements, and modifications and ensure that all of the maintenance team operations and activities are maintained in compliance with respect to current corporate policies, industry standards, regulatory standards and FDA standards.
• Evaluate and determine if utility systems, process maintenance, instrumentation/calibration/electrical systems and technical cleaning systems are maintained in compliance with all applicable industry standards, regulatory standards and FDA standards.
• Ensure the maintenance team training program, standard operating procedures and equipment/system operational standards are consistent throughout the team.
• Participate in the coordination of technical support to the maintenance team on engineering issues, regulatory issues, compliance issues, calibration issues, quality issues, microbial/environmental issues, technical cleaning issues, validation issues, electrical issues and process maintenance issues.
• Assist the maintenance team during FDA and other regulatory agency inspections. Provide technical support to the maintenance team in response to the FDA and other regulatory agencies.
• Assist the maintenance team when responding to high purity water systems and environmental monitoring alert/action notifications.
• Assist with the investigation on all alert/action notifications.
• Assist with the development and maintenance of an audit program for the maintenance team and facilitate routine audits of activities, documentation, operations and related areas to ensure a continued state of compliance.
• Assist plant engineering in the evaluation and implementation of engineering improvements, policy changes, compliance improvements and optimization programs.
• Assist with the testing of proposed sanitization and maintenance procedure changes and modifications for process, utility and clean room systems.

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 Trobleshooting- Rockwell
• Knowledge on Vision Systems Trobleshooting/Adjustment- Cognex
• Knowledge on cGMP’s
• Knowledge on basic control systems hardware.

Quality Consulting Group, LLC is an equal opportunity employer, and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, genetic information, national origin, protected veteran status, disability status, or any other characteristic protected by law.