V&V process specialist

Get AI-powered advice on this job and more exclusive features. Main Activities And Responsibilities Conducting process validation activities on medical devices for product categories bags for parental nutrition , as well as on other company assets (cleanroom and sterilization) at our facility and those carried out at external suppliers. Performing activities related to CSV (Computer Software Validation) and TMV (Test Method Validation). Basic knowledge of Radiofrequency welding , assembling and packaging Planning and executing tests on the product subjected to process validation when necessary. Effectively interacting with R&D, product V&V, and Operations teams to ensure the maintenance of processes and products according to design and specifications. Collaborating with design transfer and product industrialization teams to ensure the correct transfer of device design into production. Knowledge Degree in Engineering or scientific subjects. Minimum 2 years of experience in the role or similar roles (such as production or validation engineer). Knowledge of validation strategy and management of validation documents necessary for process validation (IQ – OQ – PQ). Knowledge of statistical tools: DOE study, Gage R&R, capacity analysis (Cp, Cpk, Pp, Ppk), definition of sampling size preferably using Minitab software. Good level of English. Basic knowledge of project management Skills Teamwork Problem Solving Adaptability Critical Thinking Autonomy Seniority level Seniority level Mid-Senior level Employment type Employment type Full-time Job function Job function Management and Manufacturing Industries Medical Equipment Manufacturing Referrals increase your chances of interviewing at B. Braun Group by 2x Sant’Agata Bolognese, Emilia-Romagna, Italy 1 day ago Luzzara, Emilia-Romagna, Italy 2 weeks ago Mirandola, Emilia-Romagna, Italy 1 month ago SVP, Head of Cell Therapy GMP Manufacturing & Process Development (all genders) We’re unlocking community knowledge in a new way. Experts add insights directly into each article, started with the help of AI. J-18808-Ljbffr

Location: Mirandola, Emilia-Romagna, IT

Posted Date: 7/6/2025