JT751 - SR. ASSOCIATE MANUFACTURING SYSTEMS

Quality Consulting Group; Juncos (PR); On-site; USD 85,000 - 105,000; Full time

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.

Skills

Automation experience

Engineering background

Systech System

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.