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Associate Tech Engineering / Packaging Equipment- 33177
Juncos, Puerto RicoDescription:
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
Education:
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.
Preferred Qualifications:
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
Work Methodology:
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
Education:
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.
Preferred Qualifications:
- Experience in Packaging Equipment such Thernoformer.
- Cartoner
- Case Packer
- Labeler
- Assembled equipment
- Vision System
- Serialization
- Sensors
- Cobots
- Mechanical Adjustment
- Motor replacement
- VFD
- PM
- Train Tool
- PLC Back Up
- Pneumatic
- Electrical / Mechanical Trouble shooting
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
Work Methodology:
- On-site
- 3 years and 7 months.
- 12hrs shift: 5:00 am–5:30 pm or 5:00 pm–5:30 am will vary based on the need of the project. Weekends and overtime may also be require.
- Professional Services Contract