Sr. Sterilization Engineer I - SC

Requisition ID:                       60771                          Title: Sr. Sterilization Engineer I - SC Division: Arthrex Manufacturing Inc (US02) Location: Pendleton, SC

 

 

 

 

 Arthrex, Inc. is a global medical device company and a leader in new product development and medical education in orthopedics. Arthrex is actively searching for a Senior Sterilization Engineer I. This is an exciting opportunity to make your mark on a growing organization.  Successful candidates will possess a minimum of a Bachelor's degree and direct knowledge of sterilization principles and demonstrated experience in the application of those principles. Join our talented team at a global medical device company focused on Helping Surgeons Treat Their Patients Better™.

 

Main Objective:

Maintain Arthrex Manufacturing sterilization processes in accordance with Quality Systems Requirements.

 

Essential Duties and Responsibilities:

• Become proficient in the use and diagnostics of Arthrex’s ethylene oxide and/or radiation sterilization equipment.
• Manage and maintain Arthrex Manufacturing ethylene oxide sterilization cycles and/or radiation sterilization processes in compliance with appropriate regulatory standards.
• Perform sterilization cycle evaluations and validations in conjunction with the Sterilization Science and Biological Safety Team
• Supports or performs equipment qualifications and computer system validation, where required.
• Perform audits of Arthrex Manufacturing suppliers, contract laboratories, and critical process suppliers when necessary.
• Act as front room and/or back-room representative during audits by internal teams and notified bodies.
• Ensure proper maintenance of Arthrex Manufacturing files demonstrating vendor compliance and performance including authoring and/or reviewing sterilization validations and product adoptions into existing cycles in conjunction with the SSBS Team.
• Recognize and address sterilization processing issues
• Evaluate, author and optimize sterilization procedures including employee training.
• Implement and manage the “certified operator” training program or support existing programs.
• Provide EH&S with timely communication on safety training and environmental compliance.
• Track and trend sterilization non-conformances and processing metrics
• Facilitate resolution of sterilization related MRBs CAPAs, non-conformances, and audit findings.
• Provide assistance in assessing device design for ethylene oxide sterilization and radiational sterilization methods when necessary.
• Encourage a continuous process improvements environment
• Support Arthrex business and expansion goals

 

Education and Experience:

• BS Degree in biology/microbiology, chemistry, or related science field required
• 5 years of relevant experience required.
• Experience with Ethylene Oxide exposure and/or E-beam, X-ray or Gamma radiation modalities preferred
• Certified Industrial Sterilization Specialist (CISS-R, CISS-EO) preferred

 

Knowledge and Skill Requirements/Specialized Courses and/or Training:

• Specialized training manufacturing operations, system design and development, industrial statistics, and technical writing preferred. Experience in working with sterilization standards (specifically, ISO 11135 and ISO 11137)
• Provides feedback and recommendations to management on initiative performance, goals and status.
• Frequent use and general knowledge of industry practices, techniques, and standards. General application of concepts and principles.
• Knowledgeable of FDA and ISO guidelines for the sterilization validation of medical devices r