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Shire Packaging Site Engineer in Lessines (Baxalta), Belgium
The main responsibility of this position is the support, implementation and evaluation of optimal and cost-effective technologies related to the efficient operations of the packaging lines in the Lessines site. This role will also be involved in the development, launch and life cycle management of primary and/or, secondary and/or, tertiary packaging components. The candidate will assess, develop, design, specify, test and implement packaging projects at the Lessines manufacturing packaging site. Additional responsibilities include leading in package trial runs, project start-ups (FATs/SATs), resolving manufacturing issues, and in packaging validation efforts. In addition, the candidate will lead or own change control, non-conformances and CAPA activities working with Quality and Global Labeling Operations
(75%) Execute/Lead in the introduction of new packaging equipment, components, technologies and processes by : Selection, testing and maintenance of packaging equipment; Characterizing primary, secondary and/or tertiary packaging components; Authoring and executing user requirement specifications, technical and validation protocols and reports; Working with sites to qualify packaging equipment and/or new processes including ability to lead Factory Acceptance testing and site commissioning activities; Performing and coordinating with sites for package testing related to package qualification activities; Write, develop and approve packaging specifications to support all GMP packaging and labeling activities; Evaluate, design, implement and support Track and Trace solutions across the Shire sites and CMOs
(25%)Execute/Lead in identification and implementation of programs to improve the quality and/or efficiency of commercial packaging operations by: Providing technical support to quality, manufacturing/packaging operations, supplier relations management and pharmaceutical sciences/process development; Execute various duties to support department and/or sites, such as Change Requests, Non-conformance/CAPA, department initiatives, learning activities and various operational improvement programs; Troubleshooting of components and equipment issues to resolve packaging complaints, investigation and/or deviations
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Shire is the leading global biotechnology company focused on serving people with rare diseases and other highly specialized conditions. We strive to develop best-in-class products, many of which are available in more than 100 countries, across core therapeutic areas including Hematology, Immunology, Neuroscience, Ophthalmics, Lysosomal Storage Disorders, Gastrointestinal/Internal Medicine/Endocrine and Hereditary Angioedema; and a growing franchise in Oncology.
Our employees come to work every day with a shared mission: to develop and deliver breakthrough therapies for the hundreds of millions of people in the world affected by rare diseases and other high-need conditions, and who lack effective therapies to live their lives to the fullest.