Description
Do you have a passion for Science? Would you like to apply your expertise to impact a company that follows 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.
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.
Join our dynamic Site Validation team as a Sr Validation Engineer. The department supports all areas of clinical manufacturing including support laboratories. The areas of accountability include equipment, utilities and facilities validation, CVS and daily operational support.
Main Duties & Responsibilities:
- Execute system validations for Manufacturing, Analytical and CTUs for all functions supporting the Gaithersburg Pilot Facility including Manufacturing, Analytical Sciences, Quality Control, Facilities, and Device functions.
- Manage validation lifecycle including execution of revalidations and periodic system review.
- Manage the CVS program and execute routine CVS
- Author validation protocols, reports, SOPs and other technical documents in support of the validation program at AstraZeneca.
- Executes data integrity assessments to ensure proper data generation and security for cGMP systems.
- Assists in performing project management activities.
- Support AstraZeneca’s Audit and Inspection Program.
Education & Experience Requirements:
- Bachelor's degree in engineering or sciences with 3+ years of experience, master's degree in engineering or science with 2+ years' experience, PhD Degree in Engineering or Science with 1+ years' experience or HS Diploma with 8+ years' experience.
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.