Validation Engineer

2 settimane fa

Peschiera del Garda, Veneto, Italia CEDIC A tempo pieno

We are seeking a Validation Engineer for a maternity replacement to join our growing Medical Device Validation Department. The Validation team mission is to ensure that our processes comply with regulatory standards and business requirements. As a Validation Engineer, you will support the validation process activities starting with Design & Development collaboration to manufacturing department post launch activities. You will report directly to the Validation Manager. Responsabilità o Define validation strategies with Program Managers and ensure that requirements, budget and timelines are met. o Lead validation activities, plan activities and prepare the needed documents (VMP, IQ, OQ, PQ) and oversee the test activities performed by the validation laboratory. o Lead Process Risk Analysis supported by a cross functional expert teams Regulatory, Engineering, Manufacturing and Quality departments. o Collaborate with other functions to address any non-compliance issues (post launch), perform root cause analysis and implement corrective actions. o Participate in Validation process improvements initiatives. Propose new methods and train other departments. o Participate in internal and external audits and support validation compliance matters. o Perform periodical validation monitoring reviews and re-plan activities accordingly. Qualifiche o Bachelor's or master's degree in engineering or related field, preferably in Medical Device / Pharma. o 1-3 years experience in process validation. o Data interrogation, DOE and applicable statistics. o Knowledge of assembling / packaging / injection molding process / tube extrusion (nice to have). o Good knowledge of Minitab Software or equivalent. o Good organizational and project management abilities with the ability to manage multiple tasks and priorities effectively. o Analytical and problem-solving abilities. o Ability to work in a team and good communication skills. We offer a 1 year contract as maternity replacement.

  • Validation Engineer

    2 settimane fa

    Peschiera del Garda, Veneto, Italia CEDIC A tempo pieno

    We are seeking a Validation Engineer for a maternity replacement to join our growing Medical Device Validation Department. The Validation team mission is to ensure that our processes comply with regulatory standards and business requirements. As a Validation Engineer, you will support the validation process activities starting with Design & Development...

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