Senior Validation Engineer Jobs

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 cutting-edge technology and lab spaces, all crafted to encourage collaboration and cross-functional science. We believe employees benefit from being challenged and inspired 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 growing collaboration between teams.

Summary of the group:

The Manufacturing Sciences - Engineering and Automation Department guides in facility and system engineering from inception (requirements and design) through realization (operation and lifecycle management). The department supports all functions vital for cGMP clinical manufacturing including Manufacturing, Analytical Testing, Quality Control Testing, Facility and Utility, Device testing, Labeling and Packaging. Engineering professionals in the E&A Department lead in engineering design, automation, network infrastructure, data integrity, capital project management, budgeting, validation, operational support and lifecycle management. Engineering projects range from individual equipment installation to large facility new construction and upgrades. These multiple areas of accountability build a wealth of diversity and growth opportunities for anyone interested in expertise in quality engineering and automation.

Main Duties & Responsibilities:

• Works on validation project planning by reporting on project schedules and work
• Crafts and updates Validation master plans.
• Writes deviations, root causes, corrective actions and additional testing.
• Write and performs Equipment, Facility and Process Installation/Operational/Performance Qualifications (IQ/OQ/PQ).
• Strong risk assessment understanding and experience writing those assessments.
• Leads and provides validation support to multiple projects
• Evaluates contractors for execution of validation work
• Ensures validation program meets corporate and regulatory expectations.
• Deep technical knowledge of Validation of equipment, facilities and utilities
• Leads installation activities to ensure validations standards are met.
• Acts as technical owner of specific area within validation function or as deep specialist in one validation field

Education & Experience Requirements:

Bachelor degree in science is required

Minimum 7 years experience in validation

Required Skills:

Equipment, utilities and facilities validation experience required.

Desired Skills:

PMP experience is a plus

Biotechnology manufacturing experience is a plus

Annex 1 experience is a plus

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 ambitious - 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, groundbreaking cutting edge methods and bringing unexpected teams together. Interested? Come and join our journey.

So, what’s next!

Are you ready to bring new insights 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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