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.
Position Summary
Responsible for the activities related to validation of sterilization processes across STERIS operating facilities. Activities include calibration of data collection systems, such as maintaining dosimeters and dosimetry equipment, measurement of dosimeters for report generation; 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.
What You'll Do as a Scientist I
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 dosimeter calibrations or 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.
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, ret
