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Process Engineer, R&D - Process Engineer and Packaging (PEP) - Device Assembly

Lieu Gaithersburg, Maryland, États-Unis Job ID R-140348 Date de publication 06/15/2022

Do you have a passion for Combination Products and Process Engineering? Would you like to apply your expertise to impact a company that follows the science and turns ideas into life changing medicines? Then AstraZeneca might be the one for you!

At AstraZeneca, we put patients first and strive to meet their unmet needs worldwide. Working here means being entrepreneurial, thinking big and working together to make the impossible a reality. If you are swift to action, confident to lead, willing to collaborate, and curious about what science can do, then you’re our kind of person.

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 inspire collaboration and cross-functional science. We believe employees benefit from being challenged and inspired at work. We are dedicated to creating 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 work spaces to suit a variety of working styles while increasing collaboration between teams. 

Summary of the group:

The Process Engineering and Packaging Group (PEP) Group sits in the BioPharmaceutical R&D organization and has offices in Gaithersburg, MD and Cambridge, UK. The group is responsible for designing, developing, and implementing biopharmaceutical and device assembly processes. The product portfolio that PEP supports is mainly focused on subcutaneous drug delivery system(s), and also assessing manufacturability of several new Technology Development projects in other related areas.

Work executed is based on an understanding of engineering fundamentals, product requirements, and business needs. Typical development work includes technology/process selection, characterization, design transfer, engineering calculations and/or simulations based on mechanistic and statistical models; GMP, design controls and risk management compliance, collaboration with external vendors and CMOs, and appropriate sequencing and interpretation of development work to ensure program goals are met.

Main Duties & Responsibilities:

  • High functioning technical and collaborative member of a cross functional device development teams to meet program deliverables.

  • Applies engineering principles with minimal oversight in the design and development of robust process and drug/device combination product assembly

  • Able to independently solve complex problems using tools such as: engineering modelling and simulation tools, design and prototyping tools, statistical analysis, benchtop experiments and analysis, usability engineering tools, design for manufacturability/assembly techniques and design for six sigma.

  • Strong working knowledge and experience with regulations and standards such as design controls, risk management, human factors and industry standards specific to an individual’s discipline

  • Identifies and effectively communicates potential design/process problems, analyses problems following best practices, provides practical solutions and manages the consequences of any failures

  • Represents the Function internally as well as externally with CMOs and development partners.

Education & Experience Requirements:

  • Bachelor’s degree in Mechanical or Biomedical Engineering, or related discipline with 5+ years of experience in an engineering related role

  • A minimum of High School Diploma and 8+ years of experience in a relevant engineering or technical manufacturing role considered in lieu of a Bachelor's Degree

Required Skills:

  • Experience and thorough understanding of process engineering and design transfer activities.

  • Demonstrated experience of process characterization, design controls and process related risk management

  • Validation of Equipment, Process and Shipping Configurations

  • Extensive experience of working in a cross functional product development environment or manufacturing team environment.

  • Excellent communication skills (both written and oral) to summarize development work, critical conclusions and its relevance to the bigger picture

  • Demonstrated experience in one or several of the following areas: process engineering, design transfer, combination product development, fixture/test methods development, device/process characterization, design controls, risk management

Desired Skills:

  • Experience in process engineering and/or Design Transfer of medical devices or drug/device combination products for subcutaneous delivery.

  • Technical leadership of cross-functional development teams

Why AstraZeneca?

At AstraZeneca when we see an opportunity for change, we seize it and make it happen, because any opportunity no matter how small, can be the start of something big. Delivering life-changing medicines is about being entrepreneurial - finding those moments and recognising their potential. Join us on our journey of building a new kind of organisation to reset expectations of what a bio-pharmaceutical company can be. This means we’re opening new ways to work, pioneering cutting edge methods and bringing unexpected teams together. Interested? Come and join our journey.

So, what’s next!

Are you ready to bring new ideas and fresh thinking to the table? Brilliant! We have one seat available and we hope it’s yours.

Where can I find out more?

Check out our landing page for more information on our BPD group

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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.

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