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Vantive • Sondalo, Lombardy, Italy
Role & seniority: Validation Engineer (mid-level typical; seniority not explicitly stated)
Stack/tools: GMP/validation practices; IQ/OQ/PQ protocols and reports; production validation; CAPA/PA; basic statistics; MS Office; English proficiency
Lead and manage validation activities for equipment, processes, utilities, and computer systems to maintain validated state over time
Draft and review validation protocols and reports (IQ/OQ/PQ) in compliance with applicable regulations
Perform validation in production environments and conduct statistical analysis of data; collaborate on new installations; manage CAPA/non-conformities
Degree in Engineering, Pharmacy, Biology, or related fields
Strong interpersonal, organizational, and team-building abilities
Proficiency with MS Office; good written and spoken English
Basic statistics knowledge
Prior experience in pharmaceutical validation (preferred)
Prior pharmaceutical validation experience
Location & work type: Location not specified; work type not specified in provided text
Vantive is a vital organ therapy company on a mission to extend lives and expand possibilities for patients and care teams everywhere. For 70 years, our team has driven meaningful innovations in kidney care. As we build on our legacy, we are deepening our commitment to elevating the dialysis experience through digital solutions and advanced services, while looking beyond kidney care and investing in transforming vital organ therapies. Greater flexibility and efficiency in therapy administration for care teams, and longer, fuller lives for patients— that is what Vantive aspires to deliver. We believe Vantive will not only build our leadership in the kidney care space, it will also offer meaningful work to those who join us. At Vantive, you will become part of a community of people who are focused, courageous and don’t settle for the mediocre. Each of us is driven to help improve patients’ lives worldwide. Join us in advancing our mission to extend lives and expand possibilities. Descrizione del ruolo: Condurre e gestire attività di validazione per garantire che equipment/processi/sistemi computerizzati rimangano in stato convalidato nel tempo Redigere protocolli/report di convalida di processi/equipment/utilities e sistemi computerizzati (IQ/OQ/PQ) in compliance con le normative applicabili Eseguire attività di validazione in ambiente di produzione e analisi statistica dei dati Collaborare in progetti relativi a nuove installazioni e lavorare in team multifunzionali Gestire attività quali CAPA/PA e non conformità relative all’ufficio validazioni Rivalutare periodicamente lo stato di convalida dei processi e delle attrezzature Requisiti: Laurea in Ingegneria, Farmacia, Biologia o affini Ottime capacità relazionali, organizzative e di team building Buona conoscenza dei principali applicativi Office Buona conoscenza della lingua inglese scritta e parlata Conoscenza di nozioni base di statistica Preferibile esperienza pregressa in ambito farmaceutico e di validazione Reasonable Accommodation Vantive is committed to working with and providing reasonable accommodations to individuals with disabilities globally. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application or interview process, please click on the link here and let us know the nature of your request along with your contact information. Form Link Recruitment Fraud Notice Vantive has discovered incidents of employment scams, where fraudulent parties pose as Vantive employees, recruiters, or other agents, and engage with online job seekers in an attempt to steal personal and/or financial information. To learn how you can protect yourself, review our Recruitment Fraud Notice. At Vantive, your work will expand your skills, knowledge and opportunities for growth and learning to advance your career. In 2023, we began the journey to establish Baxter’s chronic kidney care and acute therapies businesses into one standalone company. We are thrilled to introduce you to Vantive. Together, we will build on our nearly 70-year legacy in acute therapies and home and in-center dialysis to provide best-in-class care to the 1+ million people we serve. At Vantive, we believe in not only building our leadership in the kidney care space, but offering meaningful work to those who join us. We offer a range of exciting career opportunities across various departments, from research and development to marketing and sales. If you are looking to drive innovation and growth at a new, purpose-driven organization, we have a place for you at Vantive.