Sr Associate Manufacturing Systems

Sr Associate Manufacturing Systems<\/span span b> with e<\/span span>xperience 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. <\/span span span span span span>

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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 span span span span span span>

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Ensure the maintenance team training program, standard operating procedures and equipment/system operational standards are consistent throughout the team span span span span span span>

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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 span span span span span span>

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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 span span span span span span>

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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 span span span span span span>

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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 span span span span span span>

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Assist plant engineering in the evaluation and implementation of engineering improvements, policy changes, compliance improvements and optimization programs span span span span span span>

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Assist with the testing of proposed sanitization and maintenance procedure changes and modifications for process, utility and clean room systems span span span span span span span>

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Requirements<\/h3>

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

Associate’s degree and 6 years of Engineering experience <\/span span span span span span span li>

Shift: 5:00 am to 5:30 pm and or 5:00 pm to 5:30 am. <\/b span span span span span span span>

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Bilingual (Spanish/English)(Write/Speak)<\/span span span span span span span>

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Availability to work 12 hour shift<\/span span span span span span>

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