Senior Validation Engineer

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 and Cell Therapy.

The areas of accountability include equipment, utilities and facilities validation, 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 Computerized systems for all functions supporting the Gaithersburg Pilot Facility including Manufacturing, Analytical Sciences, Quality Control, Facilities, and Device functions.

Lead validation lifecycle including execution of revalidations and periodic system review.

Author validation protocols, reports, SOPs and other technical documents in support of the validation program at AstraZeneca.

Performs data integrity assessments to ensure accurate 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 5+ years of experience, Master Degree in Engineering or Science with 3+ years experience, PhD Degree in Engineering or Science with 0+ years experience or HS Diploma with 10 + 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

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 insights 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!

So, what’s next!

Where can I find out more?

Check out our landing page for more information on our BPD group

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Date Posted

08-Apr-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.