What are the responsibilities and job description for the Machine engineer position at ACL Digital?
Job Summary
This is a technical engineering role providing support on system/equipment optimization strategies, upgrades, replacements, and modifications at Amgen's new advanced product assembly and packaging plant in New Albany, Ohio.
The successful incumbent will evaluate and determine if utility systems, process maintenance, instrumentation/calibration/electrical systems and technical cleaning systems are maintained in compliance with industry standards, regulatory standards, and FDA standards in the Inspection and Packaging area.
The original work schedule for this role will be an administrative schedule (Monday through Friday, approximately 8 am to 5 pm) and then move to a second shift schedule. As the facility moves into operation, the successful incumbent will be expected to join a shift team structure working to support coverage across Amgen's 24-hour operations.
Responsibilities:
- Coordinate technical 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, troubleshoot and repair equipment/system failures.
- Interpret and review utility, process system/equipment, plumbing, ductwork plans, architectural, and HVAC P&IDs.
- 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.
- MS Office: Word, Excel, PowerPoint
