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Sr. Validation Engineer- Operations

Location Coppell, Texas, United States Job ID R-121695 Date posted 22/10/2021

Experienced in a cGMP pharmaceutical or regulated industry and have a passion to grow your skills within a company that follows the science and turns ideas into life-changing medicines? If that is a yes, this exciting SrValidation Engineer role in Coppell, TX might just be your reality!

In Operations, we have a big ambition – to deliver more medicines to patients, quicker and more affordably. Backed by the investment, leadership, and a clear plan to get there, we bring personal dedication and out-of-the-box thinking.

We are driven by our commitment to deliver accelerated growth for AstraZeneca and to make people’s lives better. It pushes us to keep building on our foundations and progressing as we turn our ever-growing and increasingly complex pipeline from molecule to medicine. Be part of evolving how we work with Lean, cutting-edge science, digitalization, and sustainable practices.

Welcome to Coppell, Texas, one of over 400 sites here at AstraZeneca, providing a collaborative environment where everyone feels comfortable and able to be themselves is at the core of AstraZeneca’s priorities, it’s important to us that you bring your full self to work every day. The Lokelma ® Supply Site (LSS) has recently remodeled office space to provide a pleasant office environment to support varying work styles and collaboration needs. LSS has an on-site café with a selection of snacks and refrigerated grab-and-go items for purchase. Additionally, the site offers a food delivery service through Foodsby, allowing employees to purchase food from a variety of local restaurants to be delivered to the site, which currently includes a discounted price for LSS employees.

What you'll do:

The Quality Computer System Specialist will be responsible for helping to assure the design, installation, implementation, data integrity and validation of computer systems at the Coppell, Texas site to meet all applicable industry standards and regulatory requirements.

  • Review, prepare and perform qualification and periodic review activities for computer / process control systems. Analyse collected data against pre-determined criteria, and prepare final reports in compliance with relevant regulations, industry practices, and AZ policies and procedures
  • Coordinate validation of computerized laboratory instrumentation
  • Implementation of systems to assure that security and data integrity are maintained
  • Analyse data and information to determine whether systems are within an appropriate state of control during qualification and validation as well as in assessing the need for requalification / revalidation on a periodic basis
  • Prepare, document, and/or evaluate change controls for systems to ensure that they remain in qualified, validated state
  • Identify and investigate unusual or unexpected events, data, or sources of variation during the implementation and validation; assess and recommend disposition regarding the impact upon qualification or validation as applicable, and recommend appropriate corrective/preventive actions
  • Ensure that work is performed in accordance with applicable regulations, industry guidelines and practices, approved procedures and cGMP

Essential for the role:

  • Bachelor’s degree in a science, technical, or engineering field
  • At least 3 years’ experience in pharmaceutical or related industry with knowledge of systems design, qualification, data integrity and validation
  • Must have attention to detail. Work requires a high degree of accuracy in documentation
  • Knowledge of computer system and control system design and validation concepts including GAMP
  • Must understand concepts of qualification, validation, sampling, risk evaluation, and detection of variation
  • Able to work cooperatively with other members of the Validation Team, Quality, and Manufacturing in the design and performance of qualification and validations
  • Evaluate information collected from various sources and determine impact upon controlled state of processes, equipment, facilities, and products
  • Excellent technical writing and verbal communication skills
  • Requires the ability to apply scientific and analytical principles for solving problems and accurate design of qualifications and validations
  • Solid understanding of cGMP and other applicable guidelines and regulations

Desirable for the role:

  • Awareness of qualification of control systems and computer system validation (CSV)

AstraZeneca has taken critical steps to protecting colleagues, loved ones, and patients from COVID-19 and its variants. COVID-19 vaccination is required for all US employees, and weekly PCR COVID-19 testing is required for those who are unvaccinated or have an approved accommodation.

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 recognizing their potential. Join us on our journey of building a new kind of organization 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!

Next Steps – Apply today!

To be considered for this exciting opportunity, please complete the full application on our website at your earliest convenience – it is the only way that our Recruiter and Hiring Manager can know that you feel well qualified for this opportunity. If you know someone who would be a great fit, please share this posting with them.

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About Operations

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.

10000683 D ENGE Operations

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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.