Associate Principal Packaging Engineer

AstraZeneca•Durham, NC

About The Position

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. Accountabilities include owning the design, development, and testing of all packaging presentations for medical devices and combination products to achieve project targets in a timely fashion. You will be 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. This role requires 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. You will have 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 is also essential. You will generate and review regulatory submission documents, plans, protocols, and reports ensuring that the project objectives are met (Design History File documentation). You will contribute and support relevant information to the Design transfer team to enable successful packaging transfer to AZ manufacturing operations and/or contract manufacturing sites. Ensuring that work is performed in accordance with appropriate safety, health, environmental (SHE), quality, and compliance standards is critical. You will influence understanding and interpretation of packaging regulations. You will represent the specialist packaging area (SME) on Device Project Teams, ensuring the provision of appropriate data (technical, resource & budgetary). Understanding and influencing developments within the industry is also part of the role. You will contribute to the training and development of packaging colleagues by acting as coach/mentor when appropriate. 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.

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 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 of leading cross-disciplinary delivery teams.

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 our patients, our sustainability objectives, and our quality standards.
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 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.