Pioneering trusted medical solutions to improve the lives we touch: Convatec is a global medical products and technologies company, focused on solutions for the management of chronic conditions, with leading positions in advanced wound care, ostomy care, continence care, and infusion care. With around 10,000 colleagues, we provide our products and services in almost 100 countries, united by a promise to be forever caring. Our solutions provide a range of benefits, from infection prevention and protection of at-risk skin, to improved patient outcomes and reduced care costs. Group revenues in 2022 were over $2 billion. The company is a constituent of the FTSE 100 Index (LSE:CTEC). Change is everywhere at Convatec. It’s transforming our business, and helping us improve millions of lives. And we’re nowhere near finished. Across every part of our business, we’re pushing for better. Join us on our journey to ForeverCaring as a Specialist II- Sterilization, and you’ll do the same. Key Responsibilities Hence forward, "sterilization" implies "Ethylene Oxide (EO/EtO) Sterilization" only. Unless stated specifically the functional area is for the Denmark and Mexico locations of Infusion Care business area only. Supported by the IC BU Sterilization SME, this role will focus on: • The MDR compliance effort related to Sterilization. • Day-to-day support for sterilization procedures and instructions. • Participation in Product Development in terms of determination of sterilizability of the new/altered product design to ensure optimal sterilization. • Participation in Process Development relating to the sterilization process. • Preparation of validation protocols for sterilization processes within the cycles and products related to Infusion Device area. Review of protocols and reports from other business units on request. • Participation in Validation activities on a level to make it possible to review/approve the documents related to the activities such as validation reports. • Preparation of Procedures and Work Instructions within the sterilization area. • Perform or participate in internal and external sterilization/production site audits. • Provide support in connection with product registrations and/or inquiries from authorities and customers, and customer audits. • Support training of QA/QC staff related to release of sterilized products. • Participate in projects to support sterilization, sterility assurance, contamination controls and sterilant residue related projects. • To provide product disposition in case of NC or discrepancy initiated during routine sterilization of the Infusion care manufactured products. • To ensure validations and qualifications are prepared in due time and in cooperation with the functions involved in order to ensure their timely completion. • To provide training on the QMS documents applicable for the area of sterilization as appropriate. • To ensure the sterilization control being in compliance with all regulatory requirements, the relevant QMS procedures and/ or instructions maintained, and training provided. Skills & Experience • Excellent communication skills. • Proficiency in MS Office (required). Qualifications/Education • BS in Microbiology preferred. BA/BS in appropriate science, mathematics or Engineering accepted, or min 3 years or more experience if no appropriate science degree. • Demonstrates knowledge of ethylene oxide and radiation principles and industry standards and experience in sterilization process controls is a must. • Demonstrates expert technical knowledge of working within a controlled manufacturing environment and has experience in monitoring and maintenance of systems validation of controlled environments using national and international standards. • Fluent in English, both verbally and in writing (required). • Trained in FDA QSR’s, MDSAP, ISO 13485, EU and Canadian medical device regulations (required). • Lead Auditor (preferred). Travel Requirements • Position may involve travel up to 25% of the time, mostly within Europe but overseas travel is expected. Most trips will include overnight travel.