Scientist I

Position Summary

What You'll do as a Scientist I

• Support the conduct of scientific studies for investigation and validation purposes.
• Contribute to creating and maintaining valid sterilization processes in the medical device or pharmaceutical industry that comply to FDA regulations, ISO, AAMI, and ASTM standards.
• Act as liaison between Customer and the facility leadership during Customer driven studies.
• Assist in statistical analysis of data, such as variation analysis, specific to the modality in use.
• Contribute to successful product processing by performing dosimeter calibrations or temperature/humidity sensor calibrations.
• Ensure all internal equipment is calibrated per procedure requirements and coordinates calibrations with external vendors.
• Ensure processes are maintained in a validated state by supporting periodic verifications and execution of revalidations or requalifications following changes.

Radiation specific:

• Monitor dosimeter readout process by analyzing data and supports exercises in which routine use dosimeters are irradiated alongside reference/transfer dosimeters to determine environmental offsets.
• Ensure 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.
• Maintain and distribute dosimeters to facilities based on usage forecasts, including tracking facility wide dosimeter inventory and send monthly report to STERIS accounting.
• Assist in the validation of software maintained by Radiation Technology.

Ethylene Oxide specific:

• Provide 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.
• Work with Customers during Customer driven studies to coordinate handling of material resources for use in studies, such as dunnage loads and remote sensor availability.
• Contribute 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.
• Maintain 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.
• Communicate 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.
• Protect company confidential information by properly storing, retrieving and disseminating such information only to those authorized.
• Exhibit 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.
• Contribute 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.

The Experience, Skills and Abilities Needed

Required:

• 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).

Preferred:

• Experience in a regulated environment preferred.

Other:

• 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.

What STERIS Offers