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STERILIZATION TECHNICAL EXPERT - Medical Devices

Job Title: STERILIZATION TECHNICAL EXPERT - Medical Devices
Contract Type: Permanent
Location: Keighley, West Yorkshire
Industry:
Salary: Negotiable
Reference: J898933_1549472881
Contact Name: Tom Hammond
Contact Email: tom.hammond@russell-taylor.co.uk
Job Published: February 06, 2019 17:08

Job Description

STERILIZATION TECHNICAL EXPERT - Medical Devices

Location: North Yorkshire

Type: Permanent

Salary Competitive, depending on experience

Hours: Days, Monday - Friday with an early finish on a Friday

Our Client, a Global Healthcare Company are looking to recruit for an experience Sterilization expert who will work as a key part of their large manufacturing facility; and manage the sterilization process on site.

The Role:

  • Support the company's strategic and tactical direction through the application of technical knowledge and expertise in radiation processing and other sterilization processes
  • Work directly with Project Leaders to define product and sterilization needs for radiation, ethylene oxide and moist heat sterilized products including validation (as required)
  • Leadership of activities to support the on-site Cobalt 60 Irradiator including (but not limited to) process improvement, dosimeter calibration and source replenishment
  • Provide technical guidance to the company to ensure compliance with international standards for sterilization
  • Perform statistical analysis of the sterilization process
  • Complete dose mapping validations for in-house gamma irradiator plant, and oversee qualification activities for contract Ethylene Oxide and Moist Heat Sterilization Processes
  • Complete technical assessments of contract sterilization facilities
  • Management of Failure Investigations, Root Cause Analysis and CAPAs related to sterilization processes
  • Be the point-of-contact for the Client /GSS QMS/Technical/Customer Audits in relation to sterilization processes
  • Actively network with the internal and external scientific, technical and regulatory community to maintain up-to-date knowledge of the sterilization industry
  • Execute programs to develop, train and maintain sterilization competencies across the business for new hires, as well as the current/next generation Sterility Assurance talent to ensure understanding and compliance with business and regulatory standards

The Person:

  • Will hold a Degree in a scientific or engineering discipline
  • A minimum of 4 years of experience of working with sterilization processes in a related field
  • Working knowledge of one or more of the following sterilization modalities: Radiation (mandatory), moist heat, ethylene oxide, or other related modalities (advantageous).
  • Demonstrated experience with the following standards: EN ISO 11137, EN ISO 11135, EN ISO 17665 and EN ISO 13485
  • Knowledge in Quality System activities and QA compliance for change control, calibration, preventative maintenance, data analysis, and documentation
  • Working knowledge of statistics

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