Sr Associate Manufacturing Systems

QRC Group, LLC • Juncos, PR

3d • Onsite

About The Position

Sr Associate Manufacturing Systems with experience in FDA regulated Industries and PLC programming and troubleshooting - Rockwell. Knowledge on Vision Systems Troubleshooting/Adjustment, Cognex, cGMP's, Systech Vision System and basic control system hardware.

Requirements

• Master’s or Bachelor’s degree and 2 years of Engineering experience or Associate’s degree and 6 years of Engineering experience
• Bilingual (Spanish/English)(Write/Speak)
• Experience in FDA regulated Industries
• PLC programming and troubleshooting - Rockwell
• Knowledge on Vision Systems Troubleshooting/Adjustment, Cognex
• Knowledge of cGMP's
• Knowledge of Systech Vision System
• Knowledge of basic control system hardware

Responsibilities

• 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.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Education Level: Associate degree
• Number of Employees: 1-10 employees