Sr Associate Tech Engineering - 35047

Knowledge on Mechanical Equipment Adjustment/Troubleshooting
Knowledge on PLC Systems Troubleshooting– Rockwell
Knowledge on Vision Systems Troubleshooting/Adjustment– Cognex
Knowledge on cGMP’s
Knowledge on Systech Vision System Troubleshooting\Adjustments.
Nice to have - Work experience on FDA regulated industries.
Knowledge on basic control systems hardware.

Shift: Could be assigned to any of the four shifts. Availability to 5 am – 5:30 pm and/or 5 pm – 5:30 am

GENERAL 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.
**Other functions that may be assigned

EDUCATION/LICENSES
- Master’s degree or bachelor’s degree and 2 years of Engineering experience or associate’s degree and 6 years of Engineering experience or High school diploma / GED and 8 years of Engineering experience.

COMPETENCIES/SKILLS
- Leadership and teambuilding, Organization, Facilitation, Dealing and managing change
- Verbal communication and Written Communication/Technical Writing
- Comprehensive understanding of validation protocol requirements
- Equipment Technical experience
- Analytical Problem Solving, Project Management & Planning, Scheduling
- Computer Literacy