Description:
SUMMARY
In a full automation role, the Sr Associate Tech Engineer 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.
Shift: Could be assigned to any of the four shift A, B C and D. Availability to 5 am – 5:30 pm and/or 5 pm – 5:30 am
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
- 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
What attributes (i.e. - preferred qualifications) would make this candidate stand out?
Are there specific educational/software requirements needed?
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
What attributes (i.e. - preferred qualifications) would make this candidate stand out?
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.
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