Abbott Sterilization Engineer in Buffalo Grove, Illinois
At Abbott, we're committed to helping people live their best possible life through the power of health. For more than 125 years, we've brought new products and technologies to the world -- in nutrition, diagnostics, medical devices and branded generic pharmaceuticals -- that create more possibilities for more people at all stages of life. Today, 99,000 of us are working to help people live not just longer, but better, in the more than 150 countries we serve.
The Sterilization Engineer position is focused on supporting a new manufacturing line in the Chicago area for our FreeStyle Libre product (recently PMA approved). This is an individual contributor with comprehensive knowledge in the specific area of appropriate regulations and/or standards related to sterilization. Support the development, implement and maintain manufacturing systems/equipment in accordance with site production systems for quality and good engineering practices. Operates as sole manufacturing engineering function to provide accurate & timely resolution of issues and provides support to engineering and project management for new manufacturing process equipment.
Work with equipment owners to provide accurate and timely resolution of issues impacting the manufacturing processes.
Evaluate, select and order equipment used to support the manufacture of reagents.
Oversee the installation, modification, upgrade and maintenance of manufacturing equipment.
Implement, document, and maintain controlled, repeatable production processes.
Create and upgrade equipment operating procedures to be used by manufacturing personnel.
Assist in development of qualification and validation protocols.
Participate in and/or lead qualification and validation activities.
Identify, investigate and resolve production yield issues or equipment reliability issues.
Interface with other departments and suppliers to address root cause.
May perform other duties as assigned.
B.S. in Engineering and/or equivalent training and experience 5- 10 years’ experience in a high-volume manufacturing environment to include some or all of the following: Developing and implementing manufacturing and /or qualification procedures, Excellent analytical and problem solving skills. Knowledge of production cleanrooms, preferably with experience in ISO 8 clean rooms. Ability to extract technical requirements from various sources and create executable protocols and prepare GMP compliant test reports. Knowledge of a Radiation sterilization modalities. Experience in execution of sterilization validation/re-validation, new product qualification, troubleshooting sterilization issue. Experience in execution of shipping validations and /or shelf life assessment. Knowledge of microbiology and its industrial application in the medical device / pharmaceutical or similar industry.
An Equal Opportunity Employer
Abbot welcomes and encourages diversity in our workforce.
We provide reasonable accommodation to qualified individuals with disabilities.
To request accommodation, please call 224-667-4913 or email email@example.com