Senior Specialist - Sterilisation

at  ConvaTec

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).

EDUCATION / QUALIFICATIONS:

• BS in Microbiology preferred. BA/BS in appropriate science, mathematics or Engineering accepted, or 5 years or more experience if no appropriate science degree.
• Communicative level of English language.

As a Senior Specialist – Sterilisation (f/m/d) you will work within prescribed GMP/ISO/GLP Standards and ensure compliance to all applicable national and international regulations. Position supports new and existing products and develops strategies and systems to support sterilization activities for Continence Care business unit. You will Provide sterilization engineering support to both existing manufacturing operations and new product development while working with manufacturing and development teams to evaluate, develop and validate appropriate sterilization processes. Position will have the opportunity to support operations on programs within the cleanrooms and interact with Operations and technical teams on trending, excursions and assessing the impact of environmental or device changes. This role has a direct impact on the quality of existing products, as well as products during design and development.

Your key duties and responsibilities as a Senior Specialist – Sterilisation:

• Ensure that the company contractual sterilization processes performed at contract sterilization sites are effective and in compliance with all current regulatory requirements.
• Manage, train, and develop site sterilization SMEs.
• Provide training on the QMS documents applicable for the area of sterilization as appropriate.
• Ensure the sterilization control being in compliance with all regulatory requirements, the relevant QMS procedures and/ or instructions maintained, and training provided.
• Provide product disposition in case of NC or discrepancy initiated during routine sterilization of the Continence Care manufactured products.
• Ensure validations and qualifications are prepared in due time and in cooperation with the functions involved in order to ensure their timely completion.