Senior Device Assembly Process Engineer - BPD
Do you have a passion for Science? 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:
This position can be filled at either the Engineer or Senior Engineer level. The candidate will support assembly process development for medical devices and/or combination products, which may include accessorized prefilled syringes, auto-injectors, and/or other devices.
Main Duties & Responsibilities:
This position can be filled at either the Engineer or Senior Engineer level. The candidate will support assembly process development and transfer activities for medical devices and/or combination products, which may include accessorized prefilled syringes, auto-injectors, and/or other devices to establish assembly process steps, associated operational design space, control strategy, and perform design for manufacturability/assembly assessments at clinical and commercial manufacturing sites.
Primary accountabilities will include:
•Able to lead small cross functional teams/programs with minimal oversight. High functioning collaborative team member for programs with substantial scope. Can provide support/mentorship to junior staff
•Perform risk analyses and conduct laboratory or engineering studies to characterize processes. Test, analyze and interpret a range of assembly methods on device or combination product performance (e.g. injection time, glide force).
•Contribute to the operation of a fill-finish/assembly pilot laboratory with lab scale capabilities including vial and syringe filling, lyophilization, and device assembly.
•Support engineering and Clinical/Commercial GMP runs at assembly sites. Review and approve batch records, validation protocols, and other GMP documents. Provide on-site support for assembly activities and support to close non-conformances. Regulatory writing responsibilities include supporting clinical and commercial filings.
•Demonstrated ability to manage and integrate technologies/processes in the development, scale up and commercialization of complex multicomponent products that will be manufactured across a global network of suppliers
•Some travel is required (typically 5 – 15 trips per year) in the US and abroad.
Education & Experience Requirements:
Bachelor's in mechanical engineering, biomedical engineering, materials engineering or related engineering fields with 5+ years of device development/manufacturing experience in a regulated industrial environment. Higher degrees in the related engineering fields is an asset.
- Biopharmaceutical / combination drug product development
- Assembly, label and packaging processes and equipment
- Validation of Equipment, Process and Shipping Configurations
- Leadership and interpersonal communication
- Combination product and cGMP regulations
- Design Transfer experience or experience organizing and leading cross-functional teams
- QbD, experimental design, statistics, data analysis
- Technical writing and documentation
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 https://careers.astrazeneca.com/bpd
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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.