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