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Principal Engineer, Packaging Design

Location Gaithersburg, Maryland, United States Philadelphia, Pennsylvania, United States Job ID R-202224 Date posted 11/06/2024

Join our Oncology R&D team as a Principal Engineer of Packaging Design and participate in our ambitious goal to deliver 6 new molecular entities by 2025.

In this role, you will be responsible for the planning, design & development, qualification and transfer of packaging materials (secondary and tertiary), as well as all aspects of their manufacture and use in the manufacture, storage, and transport of the final drug product throughout its lifecycle. The person will travel to AZ site locations as needed.

Accountabilities:

You will lead the packaging group within biologics GTO to achieve best-in-class, optimized packaging. You will also plan, design, develop, qualify, transfer, and support the manufacturing of packaged products in accordance with business needs and laws/regulations throughout a product’s lifecycle.

Essential Skills/Experience:

  • Bachelor’s degree in engineering or related field.
  • Minimum of 14 years of significant engineering or operational experience.
  • Excellent problem-solving abilities.
  • Strong interpersonal, organizational, collaboration, and communication skills.
  • Demonstrated ability to progress a packaging project from inception to commercialization, including packaging materials, designs and manufacturing processes, qualification, validation, and systems.
  • Experience designing packages with auto-CAD for secondary packaging systems for vials and combination products (accessorized pre-filled syringes, auto-injectors) and tertiary systems.
  • Experience in designing shipping qualification studies (real and simulated with accelerometers).
  • Experience in transferring and supporting assembly, label and pack production.
  • Knowledge of current Good Manufacturing Practices (cGMPs), packaging laws, regulations, and guidance, and experience authoring quality management system (QMS) documents: change controls, CAPAs (Corrective Actions / Preventive Actions) and deviations.
  • Authoring study protocols, reports, specifications, SOPs, batch records, etc.
  • Ability to travel to AZ site locations as needed. up to 20%

Desirable Skills/Experience:

• Experience in product serialization for tracking and traceability.

When we put unexpected teams in the same room, we unleash bold thinking with the power to inspire life-changing medicines. In-person working gives us the platform we need to connect, work at pace and challenge perceptions. That’s why we work, on average, a minimum of three days per week from the office. But that doesn't mean we’re not flexible. We balance the expectation of being in the office while respecting individual flexibility. Join us in our unique and ambitious world.

Why AstraZeneca?

Join the team dedicated to Oncology, with an ambition to eliminate cancer as a cause of death. It's our big vision that unites and inspires us. With multiple indications and high-quality molecules at all stages of our innovative pipeline, we keep pushing forward. Fusing cutting-edge science with the latest technology to achieve breakthroughs. Backed by investment, we are aiming to deliver 6 new molecular entities by 2025.

A place built on courage, curiosity and collaboration. we make bold decisions driven by patient outcomes. Empowered to lead at every level, free to ask questions and take smart risks that write the next chapter for our pipeline and Oncology team.

Pioneers of collaborative research we have built an unrivalled scientific community both internally and externally. Fusing academia and industry, we have united some of the world's foremost medical centres. Working seamlessly and inclusively, together we expedite research in some of the hardest-to-treat cancers.

Have the opportunity to build a rewarding and meaningful career as part of the team committed to improving the lives of millions with cancer.

Ready to make a difference? Apply now!

AstraZeneca embraces diversity and equality of opportunity. We are committed to building an inclusive and diverse team representing all backgrounds, with as wide a range of perspectives as possible, and harnessing industry-leading skills. We believe that the more inclusive we are, the better our work will be. We welcome and consider applications to join our team from all qualified candidates, regardless of their characteristics. We comply with all applicable laws and regulations on non-discrimination in employment (and recruitment), as well as work authorization and employment eligibility verification requirements.

10000887 F ENMP

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Great culture, great work assignments, supportive management. Rotation opportunity within the company. They value inclusion and diversity.