Scientist I

STERIS•Libertyville, IL

17d•Onsite

About The Position

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 The Scientist I is responsible for the activities related to validation of the X-ray sterilization process at the STERIS Libertyville facility. Activities include: Customer coordination to align protocol study design with routine processing needs, generation of validation studies for products, execution of product validations, execution of studies for purposes of process characterization and investigation, validation maintenance of the X-ray sterilization process, measurements using dosimetry systems, analysis of study data and evaluation against acceptance criteria, scientific protocol report generation, calibration and verification of dosimetry equipment, and other routine tasks as directed by the immediate supervisor or manager.

Requirements

B.S. degree in a technical discipline
Ability to demonstrate mathematical and technical competence for problem solving.
Proficient in use of MS Excel, MS Word, MS PowerPoint.
Able to complete statistical and data analysis using statistical tools such as MS Excel.
Academic knowledge of Quality Systems and working in a regulated environment.
Academic knowledge of Good Documentation Practices (GDP)
Ability to effectively read, write and verbally communicate.
Ability to work under general direction of a supervisor or senior team member.
Ability to work well with others.
Above average organizing, analyzing and Level 4 math skills (advanced algebra and/or calculus and/or statistics) to determine organizational, Customer and regulatory problems and formulate corrective action plans; attention to detail.
Ability to adapt to changing duties and responsibilities.
Normal hearing range sufficient to hear alarms, bells, horns, etc.

Responsibilities

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.
Monitors dosimeter readout process by analyzing data and supports exercises in which routine use dosimeters are irradiated alongside reference/transfer dosimeters to determine environmental offsets.
Ensures STERIS dosimetry equipment at all facilities is operating within specifications and supports resolution and investigation into any issues related to dosimetry equipment.
Responsible for creating critical dosimetry equations in the Operations Data Management System for STERIS facilities.
Maintains and distributes dosimeters to facilities based on usage forecasts, including tracking facility wide dosimeter inventory and send monthly report to STERIS accounting.
Assists in the validation of software maintained by Radiation Technology.