Job Description:
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.
Join our dynamic Site Validation team at our Gaithersburg, Maryland facility as an Associate Engineer. This modern and vibrant scientific campus is home to R&D and Oncology in the US, employing more than 3,500 experts in our field.
As an Engineer Associate you will support all areas of clinical manufacturing including support laboratories and Cell Therapy. The areas of accountability include equipment, utilities and facilities validation, and daily operational support. This role offers a wealth of diversity and growth opportunities for anyone interested in expertise in quality engineering.
Accountabilities:
As an Associate Engineer, you will complete system validations for Manufacturing, CTUs, Analytical and Computerized systems for all functions supporting the Gaithersburg Pilot Facility including Manufacturing, Analytical Sciences, Quality Control, Facilities, and Device functions. You will manage validation lifecycle including execution of revalidations and periodic system review. You will also author validation protocols, reports, SOPs and other technical documents in support of the validation program at AstraZeneca. Additionally, you will complete data integrity assessments to ensure proper data generation and security for cGMP systems and assist in performing project management activities. Lastly, you will support AstraZeneca's Audit and Inspection Program.
Essential Skills/Experience:
- Bachelor's degree in engineering or sciences with 2+ years of experience or High School Diploma with 6+ years of experience
- Demonstrated technical writing skills
- Excellent organization and interpersonal skills
- Ability to work effectively in teams and cultivate collaborative relationships
- Effective communication and facilitation skills
Desirable Skills/Experience:
- Temperature Mapping and Control Temperature Unit Validation
- GMP experience in a pharmaceutical or biotech manufacturing environment
- Operational experience with analytical or manufacturing systems
- Qualification, validation, or general testing experience
- Project management experience including creation of project plans
- Issue Resolution / management of change
At AstraZeneca, we are dedicated to creating a culture of inclusion and collaboration. We believe employees benefit from being challenged and inspired at work. We are proud to be part of a team playing a critical role in driving meaningful change in the way we predict, prevent and treat patients' conditions. We are at the forefront of creating new solutions that put patients at the core, powering the business to more efficiently predict, prevent and treat their conditions. We are high-reaching self-starters, proactively driving our own learning. We balance our hyper-focus and results-driven mindset with an approach that is welcoming and down-to-earth.
Are you ready to join our journey as we move beyond precision medicines to work towards individualised medicines developed through our deep understanding of individual biology and behaviours? Apply now to be part of our value-driven business, built on a collaborative culture
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
Our Social Media, Follow AstraZeneca on LinkedIn https://www.linkedin.com/company/1603/
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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 authorization and employment eligibility verification requirements.
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