Validation Engineer - Sostituzione Maternità Bardi

Validation Engineer - Sostituzione Maternità
Bardi
Emilia Romagna, Bardi

Social network you want to login/join with: Client: CEDIC Location: Job Category: Other EU work permit required: Yes Job Reference: 473095162953518284833710 Job Views: 4 Posted: 10. 03. 2025 Expiry Date: 24. 04. 2025 Job Description: 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. Define validation strategies with Program Managers and ensure that requirements, budget and timelines are met. Lead validation activities, plan activities and prepare the needed documents (VMP, IQ, OQ, PQ) and oversee the test activities performed by the validation laboratory. Lead Process Risk Analysis supported by a cross functional expert teams Regulatory, Engineering, Manufacturing and Quality departments. Collaborate with other functions to address any non-compliance issues (post launch), perform root cause analysis and implement corrective actions. Participate in Validation process improvements initiatives. Propose new methods and train other departments. Participate in internal and external audits and support validation compliance matters. Perform periodical validation monitoring reviews and re-plan activities accordingly. Qualifications: Bachelor's or master's degree in engineering or related field, preferably in Medical Device / Pharma. 1-3 years experience in process validation. Data interrogation, DOE and applicable statistics. Knowledge of assembling / packaging / injection molding process / tube extrusion (nice to have). Good knowledge of Minitab Software or equivalent. Good organizational and project management abilities with the ability to manage multiple tasks and priorities effectively. Analytical and problem-solving abilities. Ability to work in a team and good communication skills. We offer a 1 year contract as maternity replacement. J-18808-Ljbffr