Engineer - Validation - č. 2012037, aktualizované: 30. 3. 2023

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Náplň (druh) práce

Pioneering trusted medical solutions to improve the lives we touch: Convatec is a FTSE 250 global medical products and technologies company, focussed on solutions for the management of chronic conditions, with leading positions in advanced wound care, ostomy care, continence and critical care, and infusion care. Group revenues in 2021 were over $2 billion. With around 10,000 colleagues, we provide our products and services in over 100 countries, united by a promise to be forever caring. Our products provide a range of benefits, from infection prevention and protection of at-risk skin, to improved patient outcomes and reduced care costs. To learn more about Convatec, please visit http://www.convatecgroup.com


Every day, our products improve the lives of millions of people around the world. We’re hugely proud of this, which is why we’re transforming our business to reach millions more. Join us as an Engineer - Validation, and you’ll drive progress that really means something.


About the role:
Position is supposed to cover validation of manufacturing processes in manufacturing units to be performed on time and in compliance with standards.
This is one of the key positions for realizing the first production and products of good quality and to the specification within defined frame of set ups.


Your key duties and responsibilities as an Engineer - Validation:
• Validation of new production processes (except IQ) covering packaging, extrusion, catheter assembly process and if there are some additional process in the manufacturing unit in entire scope or partial scope as decided by agreement, however all processes have to be covered
• Cooperation with all others department to ensure smooth validation process in order to be aligned with time plan and regulations
• Re-validation of the processes as per time plan
• Validation of processes required to be validated as result of operational project
• Ensure availability of all necessary procedures, instructions, and forms according the rules and requirements and their compliance through validation/revalidation of the processes in manufacturing unit
• Author for Validation Protocols and Reports
• Updating and creating machine cards
• To conduct/support a process investigation, to recognize the inputs and outputs to the process by using a structured approach and tools such as process map, risk assessments, e.g. FMEA, Ishikawa diagram, flow charts
• To process and understand statistical data
• Providing regular updates to relevant manager
• Providing validation and process knowledge & expertise if required

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Cudzie jazyky

anglický - pokročilá: B1 a B2