Associate Principal Engineer

About AstraZeneca in Gaithersburg, MD:

Our Gaithersburg, Maryland facility creates life-changing medicines for people around the world.  This campus employs more than 3,500 experts in our field and is only a short drive from Washington, DC. This modern and vibrant scientific campus is the home of R&D and Oncology in the US. Here, we play host to some of the most cutting-edge technology and lab spaces, all designed to encourage collaboration and cross-functional science. We believe employees benefit from being challenged and inspired at work. We are dedicated to crafting a culture of inclusion and collaboration.

The Gaithersburg site offers a variety of amenities to help boost productivity and help keep our employees happy and healthy. This includes a fitness center, employee healthcare clinic, electric vehicle charging stations, dry cleaning, full-service cafeteria and copy center. This is where you’ll find newly designed, activity-based workspaces to suit a variety of working styles while growing collaboration between teams. 

Introduction to Role:

Are you ready to embrace constant challenges and work at the cutting-edge? Join us as an Associate Principal Engineer in our Operations team. This is a unique opportunity to contribute to life-changing medicines and shape our future in a rapidly evolving market.

Accountabilities:

As an Associate Principal Engineer, you will provide technical expertise to packaging projects supporting our cell therapy portfolio. This includes packaging design, development, qualification, and technology transfers. You will function as a liaison between R&D and commercial manufacturing, developing packaging specifications, testing and validating new packaging materials, equipment, and processes. You will also author or support documentation management policies, standard operation procedures, test methods, and work instructions related to packaging.

Essential Skills/Experience:

- Bachelor’s degree in Package Engineering, Packaging Science, Mechanical Engineering, Materials Science, or other relevant scientific/engineering field and 14+ years of relevant experience or Master’s degree and 10+ years of relevant experience or Ph.D. and 5+ years of related experience in the pharmaceutical or medical device industry.

- Experience in operations or R&D with a track record of successful delivery within a matrix organization.

- Demonstrated ability to influence cross-functionally within the organization.

- Broad and in-depth understanding of drug product packaging design and validation meeting both technical requirements as well as regulatory expectations.

- Working knowledge of testing methodologies and test standards including shock, drop and vibration tests, peel force test, barrier analysis, container closure integrity, DIN, ISO, ISTA, ASTM, USP, FDA, and EMA standards for packaging design and validation.

- Knowledge of packaging equipment and process related to drug product packaging activities and labeling systems.

Desirable Skills/Experience:

- Strong knowledge of protein science and cell biology.

- Hands-on experience with cell therapy drug product development and cryo-compatible packaging.

- Prior experience in drug product shipping qualification (e.g. bags, vials, or prefilled syringes)

- Strong analytical, technical writing, verbal communication and interpersonal skills.

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 thrive as we innovate and evolve. We foster an encouraging, positive environment where ideas are welcomed and rewarded. As part of an agile team, it's essential we speak up to offer new approaches for process improvements and faster execution. If you want to make a big impact, this is the place for you. Our contribution to life-changing medicines is why people have been here for decades. We do it for the patients.

Ready to make your mark? 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 authorisation and employment eligibility verification requirements.