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