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 proficiency and trouble shooting skills
• Understanding in PLC, Computer Serialization, Packaging Equipment, Vision Inspection System (Cognex Vision System and Systech Serialization)
• Ability to read and interpret electrical schematics and use a digital multimeter
• Excellent organizational, project management, problem solving and technical writing capability
• Strong communication: verbal / written, collaboration, influencing and facilitation
• MS Office: Word, Excel, Power Point

WHAT YOU WILL DO

Let’s do this. Let’s change the world. In this role you will provide technical engineering support on all system/equipment optimization strategies, upgrades, replacements, repairs, and modifications. You will evaluate and determine if process equipment maintenance, and technical cleaning systems are maintained in compliance with all applicable industry standards, regulatory standards and FDA standards in the Inspection and Packaging area.

RESPONSIBILITIES:

• Take part in the coordination of tech support on engineering, regulatory, compliance, quality, microbial/environmental, technical cleaning, validation, and mechanical, electrical and process automation issues.
• Assist during regulatory agency inspections. Provide technical support in response to the FDA and other regulatory agencies.
• Complete maintenance activities or operate and monitor plant support equipment in accordance with CFRs, cGMPs, SOPs, job plans and Amgen policies.
• Investigate 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.
• Ability to work night shift