Based in New Albany, Ohio, the new advanced product assembly and packaging plant. In this role you will provide technical engineering support on all system/equipment optimization strategies, upgrades, replacements, and modifications. You will 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 in the Inspection and Packaging area.
Responsibilities:
• Take part in the coordination of tech support on engineering, regulatory, compliance, calibration, quality, microbial/environmental, technical cleaning, validation, electrical and process automation 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 the team with maintaining an up-to-date working spare parts inventory system for the equipment/systems the team.
• 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 HVAC P&ID's.
• Support Operations in Non-Standard shifts that includes weekends and/or holidays as determined by business.
Basic Qualifications:
• High school diploma / GED and 6 years of Technical Engineering experience OR
• Associate's degree and 4 years of Technical Engineering experience OR
• Bachelor's degree
Preferred Qualifications:
• Educational background in Mechatronics, Computer Science, Electronic Engineering Technology, Computer Engineering or Electrical Engineering
• Understanding in PLC, Computer Serialization, Packaging Equipment, Inspection System
• SCADA/PLC Control System experience in Pharmaceutical, Medical Device or Biotechnology Industry
• Other Automated Control Systems to be supported are: Siemens and Rockwell HMI's, Cognex Vision System, Sensor and Systech Serialization
• Experience with automation system hardware and software support, including installation
• Excellent organizational, project management, problem solving and technical writing capability
• Strong communication: verbal / written, collaboration, influencing and facilitation