Sr Validation Engineer

Do you have a passion forScience Would you like to apply yourexpertisetoimpacta company that followsscienceand 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 thenyoureour 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 3500 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 mostcutting-edgetechnology and lab spaces all designed to inspire collaboration and cross-functional science.

We believe employeesbenefitfrom 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-servicecafeteriaand copy center. This is whereyoullfindnewly-designed activity-basedwork spacesto suit a variety of working styles while increasing collaboration between teams.

Joinour dynamicSite Validationteam asaSrValidationEngineer.The department supports all areas of clinical manufacturing including support laboratories. The areas of accountability include equipment utilities and facilities validationCVSand daily operational support. The multiple areas of accountability create a wealth of diversity and growth opportunities for anyone interested inexpertisein quality engineering.

Main Duties & Responsibilities:

• Execute system validations for Manufacturing Analytical andCTUsfor all functions supporting the Gaithersburg Pilot Facility including Manufacturing Analytical Sciences Quality Control Facilities and Device functions.

• Managevalidationlifecycleincluding execution of revalidations and periodic system review.

• Manage the CVS program and execute routine CVS

• Authorvalidationprotocols reportsSOPsand 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.

• Assistsin performing project management activities.

• Support AstraZenecas Audit and Inspection Program.

Education & Experience Requirements:

Bachelors degree in engineering or scienceswith3 years of experiencemasters degree in engineering or sciencewith2years experience PhD Degree in Engineering or Sciencewith1years experienceor HS Diploma with8years experience.

Required Skills:

• Demonstrated technical writing skills.

• Possesses excellent organization and interpersonal skills.

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

• Demonstratesstrong communicationand facilitation skills

Desired Skills:

• GMP experience in a pharmaceutical or biotech manufacturing environment

• Operational experience with analytical or manufacturing systems

• Qualificationvalidationor general testing experience

• Project management experience includingcreationof project plans.

• Issue Resolution / management of change

Education & Experience Requirements:

Bachelors degree in engineering or sciencesor equivalent with5 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 meanswereopening new ways to work pioneeringcutting edgemethods and bringing unexpected teams together. Interested Come and join our journey.