Validation Engineer III

Job Title: Validation Engineer III

Introduction to Role:

Join us as a Validation Engineer III, where you will provide technical and system support to Development Quality Biologics, BPD and Facilities. This role involves reviewing and approving validation protocols and reports, authoring technical documentation related to validation, qualification and risk assessments.

Reporting to the Senior Director of Quality, you will work independently and in cross-functional teams, communicating frequently with various levels of management in different functions. Be the voice of the patient and be proud to play a critical role as the eyes and ears of our patients.

Accountabilities:

As a Validation Engineer III, you will provide oversight on site validation programs, review and approve validation protocols and reports, maintain an up-to-date knowledge of validation requirements, practices and procedures. You will partner with Site Validation, Manufacturing Sciences and Facilities / Engineering departments to facilitate qualifications and validations. You will also manage multiple projects concurrently, contribute to the completion of milestones associated with projects and Quality Records, and perform Gap assessments to align local procedures to global AZ standards.

Essential Skills/Experience:

• B.S. in Engineering or Technical Field

• Minimum of Five (5) years' experience in validation within biopharmaceutical/pharmaceutical industry

• Experience performing IO/OQ/PQ on various types of equipment/system

• Effective written and oral communication skills to explain, influence, and collaborate on major initiatives

• Proficient computer skills including Microsoft Office applications

• Experience with Data Integrity regulation and application preferred

• Experience in performing large automated system qualification, cleaning validation and/or sterility validation desirable

Desirable Skills/Experience:

• Experience in a validation role (computer system validation)

• Quality Assurance experience

• Experience with Veeva electronic Quality and documentation systems

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 we need 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?

In Quality, our work is important and valued. We are always innovating, trialing the latest models and technologies to improve reliability and excellence in our processes.

We draw learnings from others, to develop and understand what it takes to drive our modern mindset forward. Here you'll feel empowered to step up, follow the science and evidence to make decisions that put patients first. We are a team of ambitious people, who want to go far and we're all here to achieve.

Ready to make a difference? Apply today!

Date Posted

09-May-2024

Closing Date

22-May-2024Our 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.