Scientist I

The Scientist I is responsible for the activities related to validation of sterilization processes across STERIS operating facilities. Activities include calibration of data collection systems, operation, and data collection related to portable temperature/humidity sensors; coordinating with external laboratories for equipment calibrations and maintenance; coordinating with Customers for test sample processing and requalification studies; coordination and proper handling of product samples for transfer to outside laboratories for testing; and other routine tasks as directed by the immediate supervisor or manager.

Expected schedule is Mon - Fri with the potential for after-hours and/or weekend work per project needs.

• Supports the conduct of scientific studies for investigation and validation purposes.
• Contributes to creating and maintaining valid sterilization processes in the medical device or pharmaceutical industry that comply to FDA regulations, ISO, AAMI, and ASTM standards.
• Acts as liaison between Customer and the facility leadership during Customer driven studies.
• Assists in statistical analysis of data, such as variation analysis, specific to the modality in use.
• Contributes to successful product processing by performing temperature/humidity sensor calibrations.
• Ensures all internal equipment is calibrated per procedure requirements and coordinates calibrations with external vendors.
• Ensures processes are maintained in a validated state by supporting periodic verifications and execution of revalidations or requalifications following changes.
• Ethylene Oxide specific:
• Provides critical support for Customer turnkey validation service(s) by executing and assisting in the management of the validation activities, such as coordination of samples receipt, placement, retrieval,
• storage and shipment, generation and maintenance of documentation for study activites.
• Works with Customers during Customer driven studies to coordinate handling of material resources for use in studies, such as dunnage loads and remote sensor availability.
• Contributes to safe and accurate processing by notifying management 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 attending safety meetings with local facility, completing safety rounds, and tracking all hazardous materials as contained in the Safety Data Sheets.
• 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.

Pay range for this opportunity is $60,000 - $75,000. This position is eligible for bonus participation.