Sterilization Science Engineer

Jabil•Memphis, TN

4d•Onsite

About The Position

At Jabil we strive to make ANYTHING POSSIBLE and EVERYTHING BETTER. We are proud to be a trusted partner for the world's top brands, offering comprehensive engineering, manufacturing, and supply chain solutions. With over 50 years of experience across industries and a vast network of over 100 sites worldwide, Jabil combines global reach with local expertise to deliver both scalable and customized solutions. Our commitment extends beyond business success as we strive to build sustainable processes that minimize environmental impact and foster vibrant and diverse communities around the globe. How will you make an impact? As the Sterilization Science Engineer, you will support the industrial sterilization process via x-ray radiation. You will be responsible for the design and development of process-to-process optimization, new product integration and maintaining a calibrated dosimetry system(s). As the Sterilization Science Engineer, you are required to be onsite in Byhalia, MS. What will you do? Support x-ray irradiator equipment validations. Installation qualifications Operational qualifications System(s) validations Support new product integration validations activities. Execution from end-to-end dose mapping/ product testing strategies Dose mapping/product testing documentation, preparation and execution activities. Analysis of dose mapping/product testing studies Procedural revisions and implementations Support irradiation operations design and development and optimization. Lead or support dosimetry systems activities. Dosimetry equipment validations Installation qualification Operational qualification Software validation Calibration activities Instrumentation maintenance Analyze calibration data from internal irradiation and laboratories. Troubleshoot sterilization process deviations; develop short- & long-term solutions to prevent reoccurrence. Use analytical and statistics to support and improve the sterilization operation. Advise development teams & operations on sterilization validation requirements, appropriate test methods and manufacturing environment to meet quality, cost and release to market objectives. Review and analyze irradiation processing reports. Interact with multi-functional work groups in a supportive role. Strategize implementation activities to successfully manage projects to completion. Independently resolve sterilization process issues and coordinate appropriate testing with the support of a more experienced sterilization scientist, specifically on unusual or especially difficult problems. Able to deal with abstract and complex “cause and effect” relationships and make sound decisions, often with limited data, which impact products and facilities. Ensure contractors meet sterilization policy requirements. Work on projects of various size and complexities, primarily on high impact complex projects. Coordinate exposure of irradiation/test samples to sterilization processes/tests to support teams. Support quality, engineering, packaging, regulatory inquiry on specific sterilization questions. Follow all company safety policies and other safety precautions within the work area. Promote radiation safety to all associates that enter the work area. Set standards for safe behavior and recognize and reward safe behavior in others. Enforce safety policies and procedures. Report on Sterilization Sciences Lead. Responsible for communicating business-related issues or opportunities to next management level. For those who supervise or manage a staff, responsible for ensuring that subordinates follow all Company guidelines related to Health, Safety and Environmental practices and that all resources needed to do so are available and in good condition, if applicable Responsible for ensuring personal and Company compliance with all Federal, State, local and Company regulations, policies, and procedures. Performs other duties assigned as needed. Other responsibilities may be assigned and not all responsibilities listed may be assigned.

Requirements

Minimum of an accredited university science degree with at least 2 years of experience in gamma or x-ray irradiation.
Knowledgeable in Radiation Processing of Medical Devices.
Knowledgeable in general qualification activities for a process, equipment and/or product.
Organizational / planning skills / interpersonal I communication skills.
Knowledgeable in AAMI/ISO Radiation Sterilization Standards.
Familiar with ASTM Radiation and Dosimetry standards.
Thorough knowledge of and be able to apply/use the above skill set.
Able to deal with abstract and complex "cause and effect" relationships and make sound decisions, often with limited data, which impact products and facilities.
Basic word processing, spreadsheet and power point skills using standard MS Office software.
Able to work effectively in a team environment, make effective management level presentations and write formal reports.
Training and experience in Good Manufacturing Practices, Good Documentation Practices and ISO standards.
Bachelor of Science, from an accredited university

Responsibilities

Support x-ray irradiator equipment validations.
Installation qualifications
Operational qualifications
System(s) validations
Support new product integration validations activities.
Execution from end-to-end dose mapping/ product testing strategies
Dose mapping/product testing documentation, preparation and execution activities.
Analysis of dose mapping/product testing studies
Procedural revisions and implementations
Support irradiation operations design and development and optimization.
Lead or support dosimetry systems activities.
Dosimetry equipment validations
Installation qualification
Operational qualification
Software validation
Calibration activities
Instrumentation maintenance
Analyze calibration data from internal irradiation and laboratories.
Troubleshoot sterilization process deviations; develop short- & long-term solutions to prevent reoccurrence.
Use analytical and statistics to support and improve the sterilization operation.
Advise development teams & operations on sterilization validation requirements, appropriate test methods and manufacturing environment to meet quality, cost and release to market objectives.
Review and analyze irradiation processing reports.
Interact with multi-functional work groups in a supportive role.
Strategize implementation activities to successfully manage projects to completion.
Independently resolve sterilization process issues and coordinate appropriate testing with the support of a more experienced sterilization scientist, specifically on unusual or especially difficult problems.
Able to deal with abstract and complex “cause and effect” relationships and make sound decisions, often with limited data, which impact products and facilities.
Ensure contractors meet sterilization policy requirements.
Work on projects of various size and complexities, primarily on high impact complex projects.
Coordinate exposure of irradiation/test samples to sterilization processes/tests to support teams.
Support quality, engineering, packaging, regulatory inquiry on specific sterilization questions.
Follow all company safety policies and other safety precautions within the work area.
Promote radiation safety to all associates that enter the work area.
Set standards for safe behavior and recognize and reward safe behavior in others.
Enforce safety policies and procedures.
Report on Sterilization Sciences Lead.
Responsible for communicating business-related issues or opportunities to next management level.
For those who supervise or manage a staff, responsible for ensuring that subordinates follow all Company guidelines related to Health, Safety and Environmental practices and that all resources needed to do so are available and in good condition, if applicable
Responsible for ensuring personal and Company compliance with all Federal, State, local and Company regulations, policies, and procedures.
Performs other duties assigned as needed.
Other responsibilities may be assigned and not all responsibilities listed may be assigned.

Benefits

Medical, Dental, Prescription Drug, and Vision Insurance with HRA and HSA options
401K Match
Employee Stock Purchase Plan
Paid Time Off
Tuition Reimbursement
Life, AD&D, and Disability Insurance
Commuter Benefits
Employee Assistance Program
Pet Insurance
Adoption Assistance
Annual Merit Increases
Community Volunteer Opportunities