Associate Principal Packaging Engineer

About the role

This position brings you to the forefront of implementing new standards and technologies, enhancing AstraZeneca's reputation as a leader in the field. Your role will involve coaching peers, leading development activities, and ensuring compliance with regulatory policies. Are you prepared to make a significant impact?

Responsibilities

• Own the design, development, and testing of all packaging presentations for medical devices and combination products to achieve project targets in a timely fashion.
• Develop innovative, creative, and cost-competitive packaging solutions that meet the needs and requirements of patients, sustainability objectives, and quality standards.
• Design, develop, and commercialize primary blister packaging systems, including blister pack design, packaging process development, DoE studies, blister qualification, and establishment of robust commercial blister packaging processes.
• Independently develop and implement blister packaging testing protocols, define critical packaging quality attributes, and evaluate packaging performance to support development, qualification, validation, and regulatory requirements.
• Manage 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 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 work is performed in accordance with appropriate safety, health, environmental (SHE), quality, and compliance standards.
• Influence understanding and interpretation of packaging regulations.
• Represent the specialist packaging area (SME) on Device Project Teams, ensuring the provision of appropriate data (technical, resource, and budgetary).
• Understand and influence developments within the industry.
• Contribute to the training and development of packaging colleagues by acting as coach/mentor when appropriate.

Requirements

• BSc/PhD level education in a relevant Engineering field (Packaging Engineering, Mechanical Engineering, Biomedical Engineering, Materials Engineering, Chemical Engineering), or in Pharmaceutical Sciences with related experience in the device and biopharmaceutical industry.
• Minimum 7 years of experience.
• Knowledge and application of cGMP requirements, Device and Combination Product requirements, in major pharmaceutical markets (USA, Europe).
• Strong technical and scientific skills with proven experience in the development of packaging solutions for parenteral and/or inhalation products.
• Strong experience with medical device or combination product commercialization, operations support, and significant packaging materials/components knowledge.
• Experience in primary blister packaging development and commercialization, including blister pack design, DoE studies, blister qualification, packaging testing, and management of external material and process suppliers.
• Lean Six Sigma Green Belt or higher certification with strong problem-solving skills.
• Demonstrated ability to simultaneously balance multiple projects of variable complexity.
• Strong operational relationships with customers.
• Experience leading cross-disciplinary delivery teams.

About Us

Join the team where everyone feels a personal connection to the people that we impact. From our science labs to manufacturing at scale, we are committed to delivering at the highest quality. It’s inspiring and gratifying work, influencing every part of the product lifecycle to deliver life-changing medicines. To ultimately make people’s lives better—from patients and their families to all of us in society.

Our mission is to build an inclusive environment where equal employment opportunities are available to all applicants and employees.