AstraZeneca is looking for a Senior Principal Packaging Engineer to provide technical leadership in the development, optimization, and qualification of innovative packaging solutions for pharmaceutical products, ensuring safe, effective, and compliant delivery of medicines worldwide. The role aims to drive new technology adoption, support regulatory compliance, and enhance sustainability and cost-effectiveness.
Requirements
- Have an excellent understanding of the overall drug development and commercialization process from development, launch and through life cycle management
- Advanced level degree in Packaging Engineering, Chemical Engineering, Materials Science, Mechanical Engineering, or a related discipline, together with extensive experience (usually 15+ years) in pharmaceutical or medical device packaging
- Have a thorough understanding of principles, applications and management of SHE and cGMP.
- Experience in Operations and/or R&D with a track record of successful project leadership and delivery within a matrix organization.
- Excellent track record of delivering high-impact packaging solutions for regulated industries and direct experience with GMP, regulatory submissions (e.g., FDA, EMA), and the relevant packaging standards (ISO, ASTM, USP).
- Direct experience with environmental sustainability initiatives, digital packaging technologies, and end-to-end product lifecycle management is strongly preferred
- Experience in or exposure to multiple disciplines in CMC and related functions (eg Product Development, Operations, Global Supply, Marketing Companies)
Responsibilities
- Provide strategic technical leadership for complex packaging initiatives, guiding multi-disciplinary project teams from early concept through commercial deployment
- Lead efforts in packaging design for both novel pipeline candidates and life cycle management of existing products, including combination products, ensuring compatibility with manufacturing, logistics, and patient needs.
- Identify emerging trends in packaging science and technology, influencing internal and external standards, and advising senior leadership on risk, strategy, and regulatory considerations
- Establish best practices for packaging design, qualification, validation, and documentation within AstraZeneca.
- Develops the strategy for the delivery of the platform technology, agreeing and taking accountability for the technical strategy for the products or platform within their area of responsibility
- Represent the company in industry forums and regulatory interactions on topics related to packaging.
- Be part of advocacy groups to maintain up to date knowledge in the changing legislation in the EU, UK and US mainly.
Other
- Conduct activities and interactions consistent with Company values and in compliance with the Code of Ethics and supporting Policies and Standards relevant to your role.
- Ensure and monitor compliance by team members and third parties by (a) positively reinforcing the Code of Ethics and all relevant AstraZeneca Policies and Standards, (b) ensuring completion of all required training, (c) fostering a culture of openness in which employees are comfortable raising questions or concerns, and (d) immediately addressing and reporting, as appropriate, instances of non-compliance.
- Manager Accountabilities at AstraZeneca include Ethical Conduct and Compliance, Team Management, Performance Management, Individual Development Planning, Talent Management, Recruitment, People information, SHE accountabilities, and Fiscal and Financial awareness.
- Leaders with accountability for GXP areas are expected to understand the legal and regulatory requirements of their roles in providing appropriate resources (which could be human, financial, material, facilities, and equipment) to maintain the Quality system and continually improve its effectiveness.
- Have interpersonal skills that influence and shape the image of the packaging organisation and department.
