Are you ready to make a significant impact on patients' lives? The GTO organization works closely and collaboratively with other Global Functions including Biopharmaceutical Development (BPD), Product Technology Development (PTD) and the Manufacturing, Science and Technology (MS&T) network across the Biologic Sites to enable excellence in manufacturing.
As a Principal Engineer of Packaging Design, 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. This is your chance to adapt and innovate at pace, experiencing the excitement and varied challenges as we launch new products.
Accountabilities:
Your role will involve leading 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?
At AstraZeneca, we are driven by the challenge to stay ahead in rapidly changing markets. We continuously seek new and better ways to deliver medicines all the way to our patients. Our resilience helps us to thrive as we innovate and evolve. We foster an encouraging, positive environment where ideas are welcomed and rewarded. If you are driven, take smart risks and are able to act quickly, then this is the place for you.
Ready to make a difference? Apply now to join our Operations team as a Principal Engineer of Packaging Design!
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.
