Infrastructure & Logistics Specialist (Open)

Infrastructure & Logistics Specialist (Open) The Opportunity Tensive is a biomedical company that is developing an innovative scaffold aiming to improve breast cancer patients’ quality of life, by offering a natural breast reconstruction. We are looking for an Infrastructure & Logistics Specialist who will manage and optimize manufacturing processes to ensure compliance with GMP requirements, focusing on enhancing production efficiency and quality. This role involves conducting time studies, equipment validation, and collaborating with various departments to improve overall equipment effectiveness and operational performance. The specialist will also contribute to the development and validation of production equipment and processes, ensuring adherence to international guidelines and regulatory standards. We love to hire collaborative and self-motivated people with a passion for learning and a teamwork spirit. Our team invests heavily in coaching new hires. Responsibilities Collect manufacturing process analytical data, develop process flow diagrams, and perform work measurements to analyze and improve existing processes. Recommend and implement modifications to equipment to improve productivity and efficiency. Coordinate activities to address equipment performance issues, develop regular maintenance tasks, and follow best practices around Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) to develop safe and quality processes. Collaborate in developing engineering documentation to define technical and functional specifications of existing and new equipment. Participate in the development and validation of equipment in compliance with internal guidelines. Collaborate with other departments and external contractors in equipment validation activities and resolving product and process non-conformities. Ensure the implementation of the Company’s Quality Management System across all activities, focusing on equipment validation and process improvements. Identify actions to ensure continuous role adequacy and updates in relation to new required knowledge. Requirements: MSc in Scientific disciplines or equivalent qualification. 2 years of experience in a manufacturing environment. Practical experience in the use and maintenance of production and laboratory tools for chemical and biological activities. Experience with Risk Analysis methods (e.g., FMEA). Knowledge of quantitative and qualitative approaches, as well as organizational, operational, and technical aspects of business processes. Good computer skills. Precision, reliability, ability to work both independently and in a team. J-18808-Ljbffr

Location: provincia-di-milano, IT

Posted Date: 11/27/2024