Descrição da Empresa

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Descrição da Função

Descrição Pursuing an ambitious growth agenda, Coloplast develops and markets products and services that make life easier for people with intimate healthcare needs. Employing about 14.000 people and with products available in more than 143 countries, they are one of the Worlds´ leading medical device companies. We are looking for an Validation Engineer. Here you will play a key role in the quality of the products produced as a partner in process validation. You will play a pivotal role in ensuring the success of our roll-out plan as the process validation is a key compliance component and the gate keeper for starting production at our new site. Furthermore, the validation of our processes is the foundation for the quality of our products and therefore for our users. Responsabilidades - Support and further the quality culture for the whole site; - Participate and lead validations on site; - Be the approver of validation and process validation related documentation; - Train, instruct and guide the organization on site within validation; - Support production – Partner towards production for validation and revalidation; - Identify and facilitate mitigation discussions for process risks; - Be the receiving end for Test Methods transfers; - Coordination of validation activities across site. Requisitos - A relevant academic background (B.Sc. or higher); - Minimum 2 years as a Validation Engineer / Test Engineer or similar within a production environment; - Solid understanding within the field of Validation and Quality i.e. GDP and GMP etc. (Quality Assurance experience is a plus); - Knowledge of process validation and process risk assessment; - Project knowledge and experience; - Production knowledge – Value chain understanding; - Holistic understanding of End-To-End production; - Fluent in spoken and written English (other languages are a plus).

Localização

• Felgueiras, Portugal