Associate Sterilization Scientist

• A Sterilization Scientist supports radiation processing operations, sterilization projects, product integration and provides multi department technical support.

DUTIES & RESPONSIBILITIES

• 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 processing activities for non-saleable products
  • timer settings, dosimetry placement, radiation strategy, documentation review and approval, customer meetings
• Support irradiator source loading activities
• Support irradiation operations establishment
• Support dosimetry systems activities
  • 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 complexity, 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 to 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.

SKILLS SETS

• Organizational / planning skills / interpersonal I communication skills
• Knowledgeable in Radiation Processing of Medical Devices
• Knowledgeable in AAMI/ISO Radiation Sterilization Standards
• Familiar in 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

EXPERIENCE AND EDUCATION

• Minimum of an accredited university/associates science degree or at least 4 years of experience in gamma irradiation.
• 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