Scientist I – Sterilization Validation

About the role

The Scientist I will support validation of sterilization processes across STERIS facilities. This role ensures that equipment, dosimetry, and temperature/humidity monitoring systems are calibrated and that data collection meets regulatory standards.

Key responsibilities

• Calibrate dosimeters and dosimetry equipment, generate measurement reports.
• Operate and collect data from portable temperature/humidity sensors.
• Coordinate equipment calibrations and maintenance with external laboratories.
• Manage customer test sample processing, requalification studies, and sample transfers to outside labs.
• Support statistical analysis of variation data and assist in periodic verifications, revalidations, and requalifications.
• Maintain documentation for validation activities and ensure compliance with FDA, ISO, AAMI, and ASTM standards.
• Act as liaison between customers and facility leadership during customer‑driven studies.

Required profile

• Degree in a scientific or engineering discipline relevant to medical device or pharmaceutical manufacturing.
• Experience with sterilization validation, dosimetry, or environmental monitoring preferred.
• Familiarity with FDA regulations and international standards (ISO, AAMI, ASTM).
• Strong attention to detail and ability to work safely in a regulated environment.

Required skills

• Dosimetry equipment calibration
• Temperature/humidity sensor calibration
• Statistical analysis of validation data
• Operation of data collection systems
• Knowledge of FDA, ISO, AAMI, ASTM standards