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Computer Validation Engineer I - Engineering and Automation

Location Gaithersburg, Maryland, United States Job ID R-110838 Date posted 10/06/2021

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 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. 

Summary of the group:

The Manufacturing Sciences Engineering and Automation Department provides expertise in facility and system engineering from inception (requirements and design) through realization (operation and lifecycle management).  The department supports all areas of BioPharmaceutical Development (BPD) from product development to clinical manufacturing.  The department supports operations in Gaithersburg, MD and the BPD functions in Cambridge, UK.  The areas of accountability include engineering design, automation, infrastructure and data integrity, capital project management and budget operations, 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 and automation.

Main Duties & Responsibilities:

  • Execute computerised 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. 
  • Lifecycle validation management of computer systems including validation, periodic review and maintenance and decommissioning
  • Reviews global standards and creates site level computer validation procedures
  • Author 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.
  • Support AstraZeneca’s Audit and Inspection Program.

Education & Experience Requirements:

Bachelor’s Degree in Engineering or Computer Sciences with 0+ years of experience.

Required Skills:

  • Demonstrated technical writing skills.
  • Requires computer expertise in MS Office Suite.
  • Hands on computer skills (hardware, software, databases, spreadsheets)
  • Possesses excellent organization and interpersonal skills.
  • Ability to build effective teams and foster collaborative relationships.
  • Demonstrates strong presentation and facilitation skills

Desired Skills:

  • GMP experience in a pharmaceutical or biotech manufacturing environment
  • Knowledge of data integrity regulations including  21CFR part 11 compliance
  • 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

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

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AstraZeneca embraces diversity and equality of opportunity. We are committed to building an inclusive and diverse team representing all backgrounds, with as wide a range of perspectives as possible, and harnessing industry-leading skills. We believe that the more inclusive we are, the better our work will be. We welcome and consider applications to join our team from all qualified candidates, regardless of their characteristics. We comply with all applicable laws and regulations on non-discrimination in employment (and recruitment), as well as work authorisation and employment eligibility verification requirements.

10000681 B ENGE R&D BioPharmaceuticals

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Glassdoor logo Rated four stars on Glassdoor

Great culture, great work assignments, supportive management. Rotation opportunity within the company. They value inclusion and diversity.