Shire Jobs

Manage and coordinate activities related to the new product launches: validation studies and process changes to support existing products and optimization of existing products/processes. This role is responsible for understanding the company's and customers' technical needs; developing, defining and implementing short- and long-term technical service strategies to achieve company and customer needs. Prepare validation documents, review and execute; and identify opportunities to improve documentation practices and compliance; manage product launches, manufacturing technology transfers to validation and manufacturing groups, process improvement; transfer the technical knowledge of the process (by working with project scientist) to manufacturing; participate in deviation investigations to identify root causes and define corrective and/or preventative actions (CAPA); provide life cycle management support to all existing products and processes, and enable execution of continuous improvement programs; review batch production records and identify opportunities to improve documentation practices and compliance; provide periodic updates to senior management on progress of projects, risk and mitigation plan; ensure staff is adequately trained to perform job assignments. May identify and develop specific training content to support ongoing development efforts, supervise and/or mentor junior level engineers. Requirements: Must have at least a Bachelor’s degree in Pharmacy or Chemistry or in a Technical Field. Must have 48 months of experience in the position or in a related manufacturing role.