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Sr Associate Tech Engineering
East, PRDescription
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.
Responsibilities
1. 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.
2. Ensure the maintenance team training program, standard operating procedures and equipment/system operational standards are consistent throughout the team.
3. 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.
4. 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.
5. 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.
6. 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.
7. Assist plant engineering in the evaluation and implementation of engineering improvements, policy changes, compliance improvements and optimization programs.
8. Assist with the testing of proposed sanitization and maintenance procedure changes and modifications for process, utility and clean room systems.
Education
Master’s degree or Bachelor’s degree and 2 years of Engineering experience O or
Associate degree and 6 years of directly related experience
Requirements
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.
Responsibilities
1. 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.
2. Ensure the maintenance team training program, standard operating procedures and equipment/system operational standards are consistent throughout the team.
3. 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.
4. 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.
5. 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.
6. 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.
7. Assist plant engineering in the evaluation and implementation of engineering improvements, policy changes, compliance improvements and optimization programs.
8. Assist with the testing of proposed sanitization and maintenance procedure changes and modifications for process, utility and clean room systems.
Education
Master’s degree or Bachelor’s degree and 2 years of Engineering experience O or
Associate degree and 6 years of directly related experience
Requirements
- Available to work 12 hours shifts AM or PM
- 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.
- Preferred skills in the following areas:
- Leadership and teambuilding
- Verbal communication
- Written Communication/Technical Writing
- Organization
- Facilitation
- Dealing with and managing change
- Comprehensive understanding of validation protocol requirements
- Technical (Equipment Specific)
- Analytical Problem Solving
- Project Management & Planning
- Scheduling
- Computer Literacy