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Sterilization Specialist

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Date: Jun 24, 2021

Location: Ballina, MO, IE

Company: Hollister Incorporated

Summary:

 

This role is within our Compliance group in Quality, Continence Care. The purpose of the position is to provide sterilization assurance for Continence products in the Ballina Continence Care Plant and so contribute to the growth and profitability of Hollister

 

Responsibilities:

 

  • Perform testing and data collection for sterile products, verifying the sterilization process meets recognized standards.
  • Coordinate sample sterilization for material evaluation studies.
  • Assists with the integration of new technologies, methods, and processes.
  • Coordinate dose auditing activities for current Hollister products sterilized by radiation.
  • Gather and graph product bioburden data to determine trend development or out of limits results.
  • Complete annual review of sterile product families, interpret the results and communicate in compliance with standard requirements.
  • Gather and graph data collected for cleanroom monitoring to determine trend development or out of limit results.
  • Support cleanroom isolate characterization activities.
  • Assist in investigations related to contamination control or microbiological issues.
  • Provide training to associates working in and around the clean room environment.
  • Assist in External Audits (NSAI, FDA).

 

Requirements:

 

  • 3-5 years of relevant work experience in the field of sterilization engineering, sterilization microbiology or similar
  • College or Bachelor’s  Degree in Microbiology, Biology or related study

 

Specialized Skills/Technical Knowledge:

 

  • Demonstrates knowledge of ISO Sterilization Standards (i.e. ISO 11137-1, 11137-2, 11737-1, 11737-2). 
  • Experience in sterilization processes, microbiology (bioburden and sterility testing), and environmental monitoring
  • Working knowledge of ISO13485 or ISO9001
  • Good technical capabilities, communication skills, teamwork abilities and initiative
  • Continually seeks to drive improvements in quality systems, products and processes.
  • Willing to be open to change and support and champion change
  • Excellent ability to deliver results, with strong interpersonal, communication and influencing skills
  • Proficient computer skills, including Microsoft Office Suite (Word, PowerPoint, Project, Access and Excel).

 

Hollister Incorporated is an independent, employee-owned company that develops, manufactures, and markets products for ostomy care, continence care, and wound care and develops educational support for patients and healthcare professionals. We have been in business for more than 95 years. Our products are sold in more than 90 countries and we have manufacturing and distribution centers on three continents. At Hollister Incorporated, we are passionate about the work we do, and we are committed to making life more rewarding and dignified for our Associates and for the people who use our products and services. A career at Hollister Incorporated can take many paths, all of them leading to rewarding opportunities.


Job Req ID: 29134