Sr Associate Manufacturing Systems - QRC Group - Juncos, Puerto Rico, United States

Sat, 07 Mar 2026 01:30:09 -0600

Company Description

QRC Group, LLC is a firm dedicated to offer services to the Pharmaceutical, Medical Devices and Chemical Industries in the validation and regulatory fields.

Log on now to our website http://www.qrcgroup.com/ to learn more about our services and solutions!

Job Description

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.

Functions:

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

Master’s or Bachelor’s degree and 2 years of Engineering experience or

Associate’s degree and 6 years of Engineering experience

Shift: 5:00 am to 5:30 pm and or 5:00 pm to 5:30 am.

Bilingual (Spanish/English)(Write/Speak)

Availability to work 12 hour shift

Additional Information

All your information will be kept confidential according to EEO guidelines.