Associate Tech Engineering

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/SKILLS

1. Leadership and teambuilding

2. Verbal communication

3. Written Communication/Technical Writing

4. Organization

5. Facilitation

6. Dealing with and managing change

7. Comprehensive understanding of validation protocol requirements.

8. Technical (Equipment Specific)

9. Analytical Problem Solving

10. Project Management & Planning

11. Scheduling

12. Computer Literacy

13. Experience in Packaging Equipment

14. Electrical / Mechanical Trouble shooting

Requirements

Bachelor's degree or Associate's degree and 4 years of directly related experience OR

High school diploma / GED and 6 years of directly related experience.