Validation Engineer - Sostituzione Maternità
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.
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Informazioni dettagliate sull'offerta di lavoro
Azienda: Buscojobs Località: Bardi
Emilia Romagna, BardiAggiunto: 12. 3. 2025
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