Our Mission: At STERIS, we help our Customers create a healthier and safer world by providing innovative healthcare and life science product and service solutions around the globe.
Who we are: STERIS is a growing provider of infection prevention and other procedural products and services through our family of wholly owned subsidiaries.
Responsible for the activities related to radiation processing and dosimetry across all STERIS Applied Sterilization Technologies (AST) radiation operating facilities, including calibrations, analysis of data, generation of test methods, validations, routine communication with internal Customers, and reporting as directed by the Senior Scientist and/or Principal Scientist.
Interprets quantitative data and designs statistical models for researching problems or questions.
Through analysis, identify trends, patterns and relationships in the data that provide answers to data and/or trends that have initially unidentifiable causes.
As part of data analysis, sets the parameters for what data is needed, the method of data collection, and the process and method of data analysis.
Creates tools (i.e. spreadsheets) for statistical analysis of data that can be used at the site level by multiple users.
Develops methods for comparison of data sets resulting from similar processes to determine statistical equivalence of the data sets being compared.
Supports the conduct of scientific studies for investigation and validation purposes.
Contributes to maintaining dosimetry systems for radiation sterilization processes in the medical device or pharmaceutical industry that comply to FDA regulations, ISO 9000, AAMI and ASTM standards.
Along with Scientist I and Scientist II, contributes to successful product processing by performing dosimeter calibrations.
Oversees dosimeter readout process by analyzing data and supports exercises in which routine use dosimeters are irradiated alongside reference/transfer dosimeters to determine environmental offsets.
Responsible for assisting facilities in maintaining dosimetry measurement equipment.
Provides dosimeter reader training to facility personnel and, as needed, to the Scientist I.
Makes decisions based on work within Radiation Technology and internal Customers to improve efficiency related to dosimeter calibration process, issues relating to dosimeter equipment, and general deviation resolution from routine processing.
Assists in the development of radiation and facility validation/qualification protocols and equipment by performing experimentation and calibration exercises, analyzing data; makes recommendations based upon data analysis; analyzes data from testing, makes recommendations regarding regulatory compliance issues and data analysis findings.
Assists Principal Scientist and Senior Scientist in the investigation and resolution of Customer and facility issues.
Duties - cont'd
Assists Principal Scientist and Senior Scientist in designing and execution of studies that provide justification for procedural requirements, assist in process efficiency, and are value-added to processing facilities.
Contributes to safe and accurate processing by notifying the Principal Scientist and Senior Scientist of any event, item or documentation that may have a concern in regard to regulatory or specification compliance, Customer product quality, or employee safety.
Maintains a safe work environment by adopting the STERIS Safety Culture.
Ensures all software owned and operated by Radiation Technology is validated to internal requirements.
Maintains professional skills, knowledge and abilities by attending educational workshops, reviewing professional publications and participating in professional societies.
Contributes to safe and accurate processing by notifying the Senior Scientist or Principal Scientist of any event, item or documentation that may have a concern in regard to regulatory or specification compliance, customer product quality or employee safety. Has responsibility and authority to accept or reject activities, practices or policies in regard to these issues.
Communicates in an effective manner by utilizing accepted business practices in a courteous and professional manner providing timely and accurate responses and service oriented offers of assistance.
Protects company confidential information by properly storing, retrieving and disseminating such information only to those authorized.
Exhibits a commitment to the AST shared values of Customer Satisfaction and Continuous Improvement through ensuring defect-free workmanship, assisting others to meet the Customer’s needs, searching for efficient and effective ways to reduce waste, being active and accountable for Customer satisfaction, and satisfying the Customer’s needs with a sense of urgency.
Contributes in a team effort by performing according to the guidelines outlined in the STERIS Code of Business Conduct, the GMP, Lean principles and other directives; supports the directives and decisions of higher level management and performs other duties as assigned.
Provide general coaching and support for junior staff.
A minimum of 6-8 years of general or operational experience in an FDA regulated industry.
Ability to demonstrate mastery in mathematical and technical problem solving.
Proficient in use of MS Excel, MS Word, MS PowerPoint.
Able to complete complex statistical and data analysis using advanced statistical tools.
Thorough knowledge of Quality Systems and working in a regulated environment.
Thorough knowledge of Good Documentation Practices (GDP)