Job Description:The Associate Technical Engineering will provide automation support on all system/equipment optimization strategies, upgrades, replacements, and modifications and ensure that supported areas and activities are maintained in compliance with respect to current corporate policies, industry standards, regulatory standards and FDA standards.FUNCTIONS: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. Participate in the coordination of TECHSUPPORT on engineering, regulatory, compliance, calibration, quality, microbial/environmental, technical cleaning, validation, electrical and process automation issues.3. Assist during FDA and other regulatory agency inspections. Provide TECHSUPPORT in response to the FDA and other regulatory agencies.4. Assist in the evaluation and implementation of engineering improvements, policy changes, compliance Improvements and optimization programs.
Other functions that may be assigned
COMPETENCIES/SKILLS1. Leadership and teambuilding2. Verbal communication3. Written Communication/Technical Writing4. Organization5. Facilitation6. Dealing with and managing change7. Comprehensive understanding of validation protocol requirements.8. Technical (Equipment Specific)9. Analytical Problem Solving10. Project Management & Planning11. Scheduling12. Computer Literacy13. Experience in Packaging Equipment14. Electrical / Mechanical Trouble shootingRequirements:Bachelor's degree or Associate's degree and 4 years of directly related experience ORHigh school diploma / GED and 6 years of directly related experience.
