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Role Summary
Equipment Maintenance Technician (12 hour rotation, Night Shift)
Responsibilities
Take part in the coordination of tech support on engineering, regulatory, compliance, quality, microbial/environmental, technical cleaning, validation, and mechanical equipment issues.
Assist during regulatory agency inspections. Provide technical support in response to the FDA and other regulatory agencies.
Complete advanced maintenance activities or operate and monitor sophisticated plant support equipment in accordance with CFRs, cGMPs, SOPs, job plans and Amgen policies.
Investigate complex issues or problems through the mentorship of experienced staff.
Assist with maintaining an up-to-date working spare parts inventory system for the equipment/systems.
Evaluate the current maintenance procedures and assist in the changes to optimize the maintenance program, trouble shoot and repair equipment/system failures.
Interpret and review utility, process system/equipment, plumbing, ductwork plans, architectural, and P&IDs.
Support Operations in non-standard shifts that includes weekends and/or holidays as determined by business.
Qualifications
Basic Qualifications:
Bachelor’s degree
OR
Associate’s degree and 4 years of Technical Engineering experience
Or
High school diploma / GED and 6 years of Technical Engineering experience
Preferred Qualifications:
Educational background in Mechanical Engineering, Mechatronics, or related technical degree
Experience repairing mechanical equipment in a manufacturing environment (experience with packaging equipment preferred)
Strong mechanical aptitude and troubleshooting skills
Understanding in PLC, Computer Serialization, Packaging Equipment, Vision Inspection System (Cognex Vision System and Systech Serialization)
Excellent organizational, project management, problem solving and technical writing capability
Strong communication skills: verbal / written, collaboration, influencing and facilitation
MS Office: Word, Excel, Power Point
Skills
Mechanical engineering principles
Troubleshooting and repair of mechanical equipment
Regulatory and compliance awareness
Project management and technical writing
Communication and collaboration
Education
Bachelor’s degree or Associate’s degree with relevant technical experience; or high school diploma/GED with substantial technical engineering experience
Additional Requirements
Willingness to support Operations in non-standard shifts, including weekends/holidays as required