The Sr. Associate Technical Engineering 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.
Master’s degree or Bachelor’s degree and 2 years of Engineering experience.
Ultimate Solutions Corp is an equal opportunity employer.
- Experience as automation/electronic Technician
- Working knowledge in automation system (e.g. vision system, sensors, data acquisition, PLC, robotic, lasers)
- Strong Knowledge in PLC, Computer Serialization, Packaging Equipment, Inspection System
- Other Automated control System to be supported includes Siemens and Rockwell HMI’s, Cognex Vision System, Sensor and Systech Serialization
- Experience with automation system hardware and software support, including installation
- Working knowledge of equipment mechanical process (e.g. servomotors, pneumatics)
- Experience in the support of Validation activities
- Support Operations in Non-Standard shifts that includes weekends and/or holidays as determined by business.