Associate Tech Engineering (12 hrs. Shift)- 34805

CIS International•Juncos, PR

18d•Onsite

About The Position

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: 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. Participate in the coordination of TECHSUPPORT on engineering, regulatory, compliance, calibration, quality, microbial/environmental, technical cleaning, validation, electrical and process automation issues. Assist during FDA and other regulatory agency inspections. Provide TECHSUPPORT in response to the FDA and other regulatory agencies. Assist in the evaluation and implementation of engineering improvements, policy changes, compliance Improvements and optimization programs. Other functions that may be assigned

Requirements

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

Nice To Haves

Experience with pneumatics, automatic control and vision inspection systems required.
All work must be guided by team requirements or department objectives and completed in accordance with CFRs, cGMPs, SOPs, job plans and Amgen policies.

Responsibilities

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.
Participate in the coordination of TECHSUPPORT on engineering, regulatory, compliance, calibration, quality, microbial/environmental, technical cleaning, validation, electrical and process automation issues.
Assist during FDA and other regulatory agency inspections.
Provide TECHSUPPORT in response to the FDA and other regulatory agencies.
Assist in the evaluation and implementation of engineering improvements, policy changes, compliance Improvements and optimization programs.
Identify, and resolve, all problems related to the process equipment and where possible minimize equipment downtime.
Complete advanced maintenance activities, including but not limited to preventive maintenance among other maintenance tasks.
Monitor inspection and packaging equipment, with ability to investigate and troubleshoot advance issues or problems including mechanical, electrical, or automation.
Assist the team with maintaining an up-to-date working spare parts inventory system.
Ensure that operational log paperwork, daily log files, and work order documentation is completed with accurate information.
Develop, revise, and review SOPs or job plans/work plans for work related areas.
Evaluate the current maintenance procedures and assist in the changes to optimize the maintenance program.
Recognize and report malfunctions and adjust equipment.
Provides technical expertise and act as a resource/trainer to others on maintenance support tasks and/or in the use of all the equipment used in the area.
Provides customer service to internal and external clients including ongoing support with detailed technical information and solving technical situations.