Experience:
5+ years of experience
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Employment Type:
Full time
Posted:
3/23/2017
Job Category:
Engineering
Sterilization Specialist
Hollister Incorporated | Stuarts Draft, Virginia
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Job Description

For over 90 years, Hollister Incorporated has built a strong foundation of quality medical products, quality services, and quality employees - making a difference in the lives of those we serve. Hollister Incorporated stands strong: We are an independent and employee-owned company. Committed to our customers. Dedicated to our employees. Working towards the future with a long-term vision.

Our challenge at Hollister Incorporated is to find those who share this dedication of helping others. Those searching for a way to make a difference. To leave a legacy of achievement. Knowing it takes talent, teamwork, and sheer determination.

Hollister Incorporated is a company where dedicated professionals can channel their efforts in a worthwhile cause. A company where good work is rewarded. Where contributing selflessly is highly regarded. This growing global medical device company will make the journey...with you.

 

SUMMARY

The Sterilization Specialist will assure the sterility of medical devices manufactured by or for Hollister.  This includes following the corporate sterilization validation policies and procedures, executing sterilization validation related testing, performing microbiological testing, and trending data in support of sterile product production.

 

RESPONSIBILITIES

 

New Product/Process Development Activities:

 

  • 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

 

Sustainability of Existing Sterile Product Portfolio Activities:

 

  • Perform testing and data collection for revalidation assessments of current Hollister products sterilized by ethylene oxide
  • Coordinate dose auditing activities for current Hollister products sterilized by radiation
  • Perform testing to support changes to materials/process/packaging related to the impact on the sterilization process
  • 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 with plants accordingly in compliance with standard requirements

 

Cleanroom Operation Contamination Control Activities:

 

  • 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
  • Complete annual review of contamination control practices, interpret the results and communicate with plant(s) accordingly in compliance with standard requirements

 

Assist in External Regulatory Audits (NSAI, FDA)

 

 

QUALIFICATIONS

 

Education

  • Bachelor Degree in Microbiology, Biology, or equivalent required

 

Experience

  • Minimum 4 years of relevant experience with a Bachelor degree, or minimum 2 years of relevant experience with a Masters degree.

     

  • Relevant experience is defined as working in a sterilization engineering or sterilization microbiology related field

 

Technical Knowledge or other skill

  • Demonstrates knowledge of ISO Sterilization Standards (i.e. ISO 11135, 11137-1, 11137-2, 11737-1, 11737-2)
  • Knowledge in Quality Systems standards and FDA Medical Device Regulations (i.e., ISO 13485; QSR)
  • Experience in sterilization processes, microbiology, bioburden and sterility testing
  • Strong Communication Skills
  • Lifting – up to 50 lbs.
  • Physical dexterity – typing, walking, standing, sitting
  • Ability to drive

 

 

About Hollister Incorporated

Hollister Incorporated is dedicated to helping healthcare professionals deliver better products and services that will make life more rewarding and dignified for patients. Since 1991 Hollister has been providing the type of treatment offered with the evadri System. In the United States, thousands of patients have been treated with Hollister devices. Hollister is an independent, employee-owned company that develops, manufactures, and markets healthcare products. From the earliest days of our company, there has been a strong sense of community - a connection to people. That connection is embedded in the very fabric of our company, and as we continue to develop new products and services, we are focused on meeting the healthcare needs of people throughout the global community. "Together we make a difference" means meeting the healthcare needs of people. Together with healthcare professionals and consumers, as well as with our suppliers, alliance partners, retailers, and distributors, Hollister is making a difference around the world. To learn more about Hollister Incorporated, please visit www.hollister.com.

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