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 guides 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 ground breaking technology and lab spaces, all crafted to inspire collaboration and multi-functional science. We believe employees benefit from being challenged and encouraged at work. We are dedicated to crafting a culture of inclusion and collaboration.

The Gaithersburg site offers a variety of amenities to help boost efficiency 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.

Introduction to role:
Join us at AstraZeneca as an Associate Director, Validation Engineer in our Biopharmaceuticals R&D department. In this role, you will be responsible for developing and reviewing qualification protocols and reports, coordinating system and equipment documentation collection, and driving protocols. You will also represent the Validation group in Change Control meetings and in Departmental qualifications and cleaning validation discussions. Harness diverse knowledge to move with agility and be part of a team that works seamlessly and inclusively across functions globally.

Main Duties & Responsibilities:

As an Associate Director Validation Engineer, you will act as a point of contact with different business areas, lead and handle validation projects, ensure the validation program meets corporate and regulatory expectations, maintain Validation master plans, lead contractors for execution of validation work, develop risk assessments, support audits and inspections, write and implement Equipment, Facility and Process Installation/Operational/Performance Qualifications (IQ/OQ/PQ), and write deviations, root causes, corrective actions and additional testing.

Education & Experience:
Preferred: BS with 10+ years, or, MS with 8+ years, in chemistry, biochemistry, pharmaceutical sciences, engineering, applied sciences, or related field

OR: HS Diploma with 16+ years that commensurate with job requirements

Required Skills:

• Ability to effectively lead in a matrix organization where execution depends on a team that does not directly report to you

• Demonstrated experience with regulatory and/or internal audits and inspections

• Experience authoring Validation Master plans

• Strong experience with cleaning validation

• Strong Experience with equipment validation, facilities and utilities.

• Ability to transfer knowledge: developing training materials and conveying sophisticated concepts

• Strong organizational skills and the flexibility to handle multiple tasks and deadlines

Desirable Skills:

• Project management experience is a plus

• Understanding of LEAN and/or O

• Operational Excellence (FMEA, DMAIC, root cause analysis etc.) concepts

At AstraZeneca, we are committed to turning our drug development strategies into reality. We work at all stages of development to translate our life-changing science into medicines to get the best results for AstraZeneca, patients in need and healthcare professionals. We are a diverse and open-minded team harnessing our different skills and experiences. Our differences enable us to explore new ideas and ways of doing things. It keeps us on our toes and excited for what's next. We are part of the solution, involved in key discussions, in our role we act as both a drug developer and Regulator. We think broadly about patients and what it takes to prevent and treat diseases to develop progressive solutions.

Ready to make a difference? Apply now to join our efficient and forward-thinking team!

When we put unexpected teams in the same room, we unleash bold thinking with the power to inspire life-changing medicines. In-person working gives us the platform to connect, work at pace and challenge perceptions. That’s why we work, on average, a minimum of three days per week from the office. But that doesn’t mean we’re not flexible. We balance the expectation of being in the office while respecting individual flexibility. Join us in our unique and ambitious world .”

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 innovative 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

Our Social Media, Follow AstraZeneca on LinkedIn https://www.linkedin.com/company/1603/

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Date Posted

29-Mar-2024

Closing Date

Our mission is to build an inclusive and equitable environment. We want people to feel they belong at AstraZeneca and Alexion, starting with our recruitment process. We welcome and consider applications from all qualified candidates, regardless of characteristics. We offer reasonable adjustments/accommodations to help all candidates to perform at their best. If you have a need for any adjustments/accommodations, please complete the section in the application form.

AstraZeneca requires all US employees to be fully vaccinated for COVID-19 but will consider requests for reasonable accommodations as required by applicable law.