Device Engineer - Container Closure Integrity - 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:
Device Development provides combination product expertise to the development of drug-delivery parenterals for the expanding Astra Zeneca pipeline. We are seeking a device engineer to join the Device Functionality and Safety team. The group consists of people with a diverse range of technical backgrounds including device engineers, people with equipment and test method development expertise, design controls skills and more and is responsible for successful completion of design, development and commercialization deliverables and ensuring that device design, component selection, manufacturability and testing specifications and methods meet product needs. The team is working on characterization, evaluation, and design verification of combination devices and novel technologies.
Main Duties & Responsibilities:
The candidate will be responsible for the following activities:
- Design, develop and execute experiments (DOE) for device characterization and evaluation with minimum supervision.
- Make detailed observations, data analysis, interpret results, maintain documentation, and prepare technical reports, summaries, SOP, protocols, and reports with minimum supervision.
- Be an accomplished user of Container Closure Integrity (CCI) techniques and test methods used for parenteral products. Proficient about differences of various test CCI methods. (Dye Ingress, High Voltage Leak Detection (HVLD), Mass Extraction, vacuum decay, …)
- Be an skilled user of device engineering and testing software/tool/equipment such as the tensile test machine (INSTRON), confocal and/or light microscopy, Solidworks, Minitab, and etc.
- Develop process descriptions to standardize testing procedures across analysts.
- Innovate, develop and evaluate device characterization techniques and technologies as they relate to device development requirements.
- Perform test method qualification and method transfer to GMP testing group in support of device verification & validation testing.
- Establish and foster a strong collaborative working relationship with internal departments and external vendors/suppliers.
- Ensure that work is performed in accordance with appropriate quality and compliance standards, e.g. – USP/PharmEur, ISO /MDD/GMP/GLP, 21CRF Part 4 & 820.30 and applicable safety requirements. Prepare and maintain documentation and formal reports in accordance with these standards.
Education & Experience Requirements:
B.S. or M.S. degree in Mechanical/Biomedical/Chemical Engineering, Pharmacy, Pharmaceutical Sciences, or related field with at least 3+ years of service in engineering related role. In lieu of degree, minimum 8 years of service in a relevant engineering role.
- Prior experience with combination products and/or medical device technologies.
- Hands on technical experience with Container Closure Integrity (CCI) test methods
- Experience with Instron or similar lab equipment, Minitab, Solidworks, 3D printer, and microscopy
- Statistical and data analysis knowledge.
- Strong communication skills, including preparing precise technical reports summaries, protocols, quantitative analyses, and maintains appropriate documentation
- Exercises significant technical discretion in design, execution and interpretation of the results of experimental outcomes.
- Candidate is expected to be an independent thinker and able to perform work responsibilities and determine technical objectives with minimal direction and supervision.
- Prior experience working with prefilled syringes, autoinjectors, and/or other drug delivery devices is a plus.
- Knowledge of medical / combination device verification & validation is a plus.
- Knowledge of global industry standards (ex ISO, AAMI, ANSI, etc..) applicable to device and/or combination product development is desired.
- A track record of working effectively within a matrix organization with a highly cross-functional and collaborative environment is desired.
- Strong work habits and commitment to the position are highly valued.
- Problem solving, innovation and creativity are also fundamental qualities for this role.
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.