Validation computer

Garantire che tutti i rischi relativi ai progetti siano gestiti correttamente e che i risultati siano convalidati (per GxP) / testato (per non GxP) in conformità a SOP e ai requisiti CSV associatiGarantire che il team di progetto rispetti la metodologia e il SOP e utilizzi gli strumenti correttiGarantire la completezza e la coerenza della documentazione del ciclo di vita del progettoAssicurarsi che tutti i problemi relativi al progetto e le deviazioni siano registrati, approvati e dispensati di conseguenza (compresa la garanzia della corretta preparazione e approvazione del rapporto di deviazione)Preparare report di progetto e del ciclo di vita e rivedere / approvare tutti gli altri documenti per garantireconformità con SOPEsperienza in Data IntegrityEsperienza di Convalida su sistemi di laboratorio, ERP, As400, SapPartecipazione ad ispezioni FDA/EMA/AIFAEsperienza consolidata nella validazione sistemi computerizzati Progetti a livello internazionale per aziende farmaceuticheEsperienza nel ruolo richiesta di almeno 3 anni, come CSV per società di consulenza o aziende farmaceutiche Volontà a frequenti trasferte sul territorio nazionale ed internazionali Capacità di essere project manager in progetti internazionali per le più grandi aziende farmaceutiche al mondoAzienda di consulenza multinazionale leader nel settore della Validazione di Sistemi computerizzati per aziende farmaceuticheGarantire che tutti i rischi relativi ai progetti siano gestiti correttamente e che i risultati siano convalidati (per GxP) / testato (per non GxP) in conformità a SOP e ai requisiti CSV associatiGarantire che il team di progetto rispetti la metodologia e il SOP e utilizzi gli strumenti correttiGarantire la completezza e la coerenza della documentazione del ciclo di vita del progettoAssicurarsi che tutti i problemi relativi al progetto e le deviazioni siano registrati, approvati e dispensati di conseguenza (compresa la garanzia della corretta preparazione e approvazione del rapporto di deviazione)Preparare report di progetto e del ciclo di vita e rivedere / approvare tutti gli altri documenti per garantireconformità con SOPEsperienza in Data IntegrityEsperienza di Convalida su sistemi di laboratorio, ERP, As400, SapPartecipazione ad ispezioni FDA/EMA/AIFATempo indeterminato CCNL Commercio (+ benefits + indennità) Retribuzione e inquadramento commisurati all'esperienza del candidato

Are you ready to take your career to new heights? At D-Orbit, were pioneering the future of space logistics and transportation. Established in 2011, our company is leading the way in helping businesses profitably and sustainably unlock the full potential of the final frontier. As a member of our team, youll have the opportunity to work alongside a diverse group of highly skilled individuals, all driven by a shared passion for innovation and excellence. Join us in our global mission to push the boundaries of whats possible and take your ambition to new heights. Apply now and join us in shaping the future of space. We are looking for a number of Embedded Software Engineers with different experience levels to join our team. You will become part of a software design group responsible for the delivery of software components across a range of embedded and high performance applications in space. Within a continuous integration environment, you will contribute to the requirements definition, design of SW architecture, coding and testing of mission critical real-time embedded software, running on the D-Orbit latest generation spacecraft. Through these activities and by working with the key stakeholders in the development process you will deliver exciting new features and support spacecraft operations. Tasks and Responsibilities: - Contribute to the entire application lifecycle, focusing on requirements definition, design, coding, debugging and integration with the flight hardware (note that the coding language used during the daily job is mostly embedded C and the software spans multiple layers, ranging from low-level components to middleware and application software) - Preparation of flight software technical documentation - Validation of features including integration with software-in-the-loop and hardware-in-the-loop test suites - Contribute to the continuous improvement of the teams processes and methodologies Additional duties may be assigned as needed by each project, like: - Define software system specifications during co-engineering activities with the system team - Improve and develop new features to shared libraries - Maintenance of existing flight applications - Support to AIV activities and spaceflight operations Required Technical Skills: - Minimum of 1 year experience in embedded software development. - Experience delivering embedded software in any C-family language - Knowledge of any typical embedded communication interfaces such as USART, SPI, I2C, CAN - Experience using and configuring any common build tool chains or similar development environment (such as ANT, WAF, Makefile, Visual Studio etc.) - Familiarity with Git versioning system or any similar DVCS - Ability to communicate technical concepts clearly and effectively - Degree, in any relevant area such as computer engineering, electronic engineering, aerospace engineering, robotics or automation. - Full professional proficiency of English language is mandatory. Nice-to-have skills: - Good understanding of SW design and testing lifecycle in regulated environment (ideally ECSS standard) - Knowledge of real-time operating systems (such as RTEMS or FreeRTOS) and/or operating systems targeted for embedded applications (such as any embedded Linux) - Experience in debugging embedded software using standard laboratory equipment - Basic understanding of Assembler language - Experience in defining software system specifications and software requirements - Knowledge of Python - Familiarity with using any Linux based distribution and appreciation of application development - Familiarity with typical software development methodology and release versioning processes - Familiarity with OBDH and TMTC architectures used in space systems - Capability of working in autonomy Language: This role requires professional proficiency in English. At D-Orbit, diversity and inclusivity are not just values, they are integral to our mission and the way we operate. We are committed to fostering an environment where all individuals are respected, valued, and celebrated for their unique backgrounds, perspectives, and experiences. We believe that a diverse and inclusive workplace is not only the right thing to do, but it also leads to better decision-making, innovation, and overall success. We actively strive to build a culture where everyone can bring their authentic selves to work, and where all voices are heard and valued. We are dedicated to creating a workplace where everyone feels safe, supported, and empowered to share their ideas, and where everyone is given equal opportunities to grow and excel. We believe that our differences make us stronger, and we will continue to work diligently to create an inclusive culture at D-Orbit that reflects this belief. Settore: Industria aerospaziale Ruolo: Ingegneria/Progettazione Gestisce altre persone: No Tipo di occupazione: Contratto a tempo indeterminato Inquadramento: Impiegato