職位描述
Job Overview:We are looking for an experienced Engineering and Pharmaceutics individual with a focus on inhalation products to join our team. This role is vital in integrating engineering expertise with pharmaceutical sciences to support the manufacturing of inhalation products. The successful candidate should have experience in managing technology transfer, new site start up, enhancing product processes, regulatory support.Key Responsibilities:Technical Support/Technology Transfer: * Lead/support technology transfer activities for inhalation product(s) from development and/or existing manufacturing facilities in Europe, ensuring smooth transitions to commercial manufacturing. * Coordinate with cross-functional teams to optimize processes and production efficiency. * Technical support related to the manufacturing of inhalation products, related to filling and assembly operations for inhalation devices.New Site Support and Startup: * Provide technical support and collaborate with site teams to establish robust manufacturing processes for new manufacturing site start up for inhalation products. * Support/participate in startup and/or qualifications activities, ensuring that processes and equipment are fully operationalRegulatory Support and Compliance: * Support regulatory compliance by preparing necessary documentation, responses to health authorities’ questions and interactions with health authorities as appropriate. * Ensure all engineering and pharmaceutics processes meet industry regulations for inhalation products.Cross-Functional Collaboration: * Facilitate collaboration between different functional teams – such as site teams and different global teams within AZQualifications: * Educational Background: * Bachelor’s or Master’s degree in Engineering, Pharmaceutics, or a related field. * Expertise in engineering principles and pharmaceutical sciences focused on inhalation devices. * Experience: * Experience with inhalation product processes, including device assembly and formulation filling. * Expertise in technology transfer and regulatory compliance for inhalation products. * Skills: * Strong analytical, problem-solving, and process improvement abilities. * Effective communication and collaboration skills. * Understanding of industry regulations for inhalation products and device manufacturing.
