Associate Principal Packaging Engineer

Own the design & development, and testing of all packaging presentations for medical devices and combination products to achieve project targets in a timely fashion. 

Accountable for developing innovative, creative, and cost-competitive packaging solutions that meet the needs and requirements of our patients, our sustainability objectives, and our quality standards. 

Proven practice in the design, development, and commercialization of primary blister packaging systems, including blister pack design, packaging process development, DoE studies, blister qualification, and establishment of robust commercial blister packaging processes. 

Experience independently developing and implementing blister packaging testing protocols, defining critical packaging quality attributes, and evaluating packaging performance to support development, qualification, validation, and regulatory requirements. 

Experience managing external packaging material suppliers and process suppliers to support packaging development, qualification, technical transfer, and commercialization activities. 

Generate and review regulatory submission documents, plans, protocols, and reports ensuring that the project objectives are met (Design History File documentation). 

Contribute and support relevant information to the Design transfer team to enable successful packaging transfer to AZ manufacturing operations and/or contract manufacturing sites. 

Ensure that work is performed in accordance with appropriate safety, health, environmental(SHE), quality, and compliance standards. 

Influence understanding and interpretation of packaging regulations. 

Represent specialist packaging area (SME) on Device Project Teams, ensuring the provision of appropriate data (technical, resource & budgetary). 

Understand and Influence developments within the industry. 

Contribute to the training and development of packaging colleagues by acting as coach/mentor when appropriate.