Engineer II - Engineering (AO Validation Engineer)

Údaje o pracovnom mieste

Náplň (druh) práce

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). To learn more about Convatec, please visit http://www.convatecgroup.com


Our search for better is changing the lives of our customers. It’s changing the careers of our people too – creating new challenges and opportunities all the time.
We’re a business that never stands still. Join us on our journey to #ForeverCaring as a Validation Engineer.


About the role:
As a Validation Engineer you will be working on projects leading to the introduction of new products and processes.
Act as Validation Subject Master Expert specifically for new equipment introduction; developing validation strategies which ensure efficient and robust introduction of new equipment, ensuring documentation and validation activities meet required standards.


Your key duties and responsibilities as a Validation Engineer:
• The Validation Engineer must participate early on in new product development project, with achieving knowledge and all needed information to develop validation approach
• Draft Master Validation Plans (MVP) for new equipment and/or change control projects
• Determine the most efficient and high quality validation strategies for both pilot and scale up manufacturing equipment, recommend and create validation and qualification approaches, priorities, with required timings & resource requirements
• Liaise with software validation Subject Matter Experts (SMEs) and supplier software design engineering to determine best software validation approaches, and build into master validation plans
• Ensure material availability and line side in readiness for validation runs
• Line side at Factory Acceptance Test (FAT) and Site Acceptance Test (SAT) as well as installation of equipment, with technical leads, engineers as required
• Perform and carry out site based validation activities including where needed, overseeing, and or creation and execution of protocols /reports, establish and maintain the technical documentation throughout the project inline with appropriate standards/procedures
• Recommend early Design of experiments (DOEs), trials on equipment to optimise delivery of validation downstream
• Review the equipment User Requirement Specifications (URS), assess the equipment proposals/designs to ensure a robust validation approach can be achieved
• Train other engineers to meet expected standards in protocol writing and reporting, as required
• Act as consult/reviewer and approver where needed for external manufactured new product equipment; validation plans and protocols
• Ensures knowledge and expertise around the product and key equipment processes are handed over to local site engineering/manufacturing

Požadované vzdelanie

Vysokoškolské vzdelanie prvého stupňa

Vysokoškolské vzdelanie druhého stupňa

Cudzie jazyky

anglický - pokročilá: B1 a B2