Manufacturing Systems Engineer
2 weeks ago
We are seeking a highly skilled Manufacturing Systems Engineer to join our team at Amgen. As a key member of our operations team, you will be responsible for providing technical engineering support on all system/equipment optimization strategies, upgrades, replacements, and modifications.
Key Responsibilities- 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.
- 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 and 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.
- Bachelor's degree in a relevant field or equivalent experience.
- Strong understanding of PLC, Computer Serialization, Packaging Equipment, Inspection System, SCADA/PLC Control System experience in Pharmaceutical, Medical Device, or Biotechnology Industry.
- Excellent organizational, project management, problem-solving, and technical writing capability.
- Strong communication skills, verbal/written, collaboration, influencing, and facilitation.
Amgen is a leading biotechnology company committed to serving patients through science-based innovation. We are dedicated to advancing science, driving discovery, and igniting innovation to help reduce disease. Our inclusive and diverse workforce is key to driving scientific innovation and problem-solving, leading to better scientific solutions that benefit both patients and society.
We offer a comprehensive employee benefits package, including a Retirement and Savings Plan with generous company contributions, group medical, dental, and vision coverage, life and disability insurance, and flexible spending accounts. We also offer a discretionary annual bonus program and stock-based long-term incentives.
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