Scientist I

Responsible for the activities related to validation of sterilization processes across STERIS operating facilities. This is NOT a laboratory-based position. 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.

• 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.
• 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 activities.
  • 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.

Required:

• Entry-level personnel with a B.S. degree in a technical or life sciences discipline (biology, chemistry, engineering, etc.).
• Ability to demonstrate mathematical and technical competence for problem solving.
• Above average organizing, analyzing and Level 4 math skills (advanced algebra and/or calculus and/or statistics).
• Proficient in use of MS Excel, MS Word, MS PowerPoint.
• Able to complete statistical and data analysis using statistical tools such as MS Excel.
• Normal hearing range sufficient to hear alarms, bells, horns, etc.
• Academic knowledge of Quality Systems and working in a regulated environment.
• Academic knowledge of Good Documentation Practices (GDP)

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.
• High attention to detail.
• Ability to adapt to changing duties and responsibilities.