Sr Validation Engineer

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. 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.   

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.   The multiple areas of accountability create a wealth of diversity and growth opportunities for anyone interested in expertise in quality engineering. 

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. 

Required Skills:  

• Demonstrated technical writing skills.  

• Possesses excellent organization and interpersonal skills.  

• Ability to work effectively in teams and foster collaborative relationships.  

• Demonstrates strong communication and facilitation skills  

Desired Skills:  

• 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  

Education & Experience Requirements: 

Bachelor’s degree in engineering or sciences or equivalent with 5+ years of 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. 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/ 

Follow AstraZeneca on Facebook https://www.facebook.com/astrazenecacareers/ 

Follow AstraZeneca on Instagram https://www.instagram.com/astrazeneca_careers/?hl=en 

The annual base pay (or hourly rate of compensation) for this position ranges from $ 101,643.20 - $152,464.80 USD Annual, either as annual base pay or as the hourly rate (annual base pay divided by 2080 hours)]. Hourly and salaried non-exempt employees will also be paid overtime pay when working qualifying overtime hours. Base pay offered may vary depending on multiple individualized factors, including market location, job-related knowledge, skills, and experience.  In addition, our positions offer a short-term incentive bonus opportunity; eligibility to participate in our equity-based long-term incentive program (salaried roles), to receive a retirement contribution (hourly roles), and commission payment eligibility (sales roles). Benefits offered included a qualified retirement program [401(k) plan]; paid vacation and holidays; paid leaves; and, health benefits including medical, prescription drug, dental, and vision coverage in accordance with the terms and conditions of the applicable plans. Additional details of participation in these benefit plans will be provided if an employee receives an offer of employment. If hired, employee will be in an “at-will position” and the Company reserves the right to modify base pay (as well as any other discretionary payment or compensation program) at any time, including for reasons related to individual performance, Company or individual department/team performance, and market factors. 

Date Posted

16-Apr-2026

Closing Date

29-Apr-2026Our mission is to build an inclusive environment where equal employment opportunities are available to all applicants and employees. In furtherance of that mission, we welcome and consider applications from all qualified candidates, regardless of their protected characteristics. If you have a disability or special need that requires accommodation, please complete the corresponding section in the application form.