Sr Validation Engineer
AstraZeneca

Coppell, Texas

This job has expired.


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 Sr Validation 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:

Responsible to perform adequate and comprehensive qualification and validation of equipment, processes, products, and facilities at the Coppell, Texas site to support the PET goals and targets.

  • Assess potential sources of variation in materials, processes, facilities, equipment, products and packaging processes that may impact consistent performance or product quality; where needed, design studies to characterize impact of identified sources
  • Evaluate equipment and processes to identify critical parameters based upon potential impact on product quality attributes
  • Prepare qualification, requalification, and process validation protocols, analyzes applicable data, and prepares final reports in compliance with relevant regulations, industry practices, and AZ policies and procedures
  • Perform and document field verification of equipment, instruments, and facilities as required by approved protocols
  • Assess accuracy of P&ID, Electrical drawing to support validation and change control
  • May provide supervision and training for less experienced or entry-level validation personnel, including review and enhancement of draft protocols, oversight of data collection, review/approval of raw data and assembled qualification packages
  • Perform risk assessment on proposed changes, document change control deliverables with respect to validation requirements
  • Complete, review, and/or approve risk assessments for instruments, equipment, processes, and products
  • Analyze data and information to determine whether processes, equipment, and products 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 and/or evaluate change controls to ensure that equipment, products, processes, and facilities remain in qualified, validated state, including definition of appropriate requirements in change control documents, completion of identified action, and preparation of applicable reports and data packages
  • Identify and investigate unusual or unexpected events, data, or sources of variation during the development and performance of qualifications/validations; assess and document the impact upon qualification or validation as applicable, and recommend appropriate corrective/preventive actions
  • Coordinate assigned qualification projects as needed with other departments as needed, e.g., Quality Engineering, Quality Assurance, Metrology, Operations, Facilities/Engineering, QC, and external resources (contractors, etc.)
  • Ensure that work is performed in accordance with regulations, industry guidelines and practices, approved procedures and cGMP

Essential for the role:
  • Bachelor's degree in science or engineering field
  • At least 5 years' experience in validation and / or qualifications in API, pharmaceutical or medical device industry
  • At least 3 years' experience in independent development, writing and performance qualifications / validation
  • Experience in and knowledge of qualification of control systems and computer system validation

Desirable for the role:
  • Proven capability to assess processes, equipment and products for sources of variation
  • Ability to analyse data and reach appropriate solutions
  • Ability to perform and appropriately document deviations and investigations
  • Must have excellent analytical skills and attention to detail. Work requires a high degree of accuracy in complex documentation
  • Must understand concepts of qualification and validation, as well as statistical sampling, risk evaluation, and detection of variation.
  • Able to work collaboratively and provide direction, as appropriate, to other members of the Validation Team, Quality, and Manufacturing in the design and performance of qualification and validations.
  • Must have the ability to learn technical subject matter quickly and integrate knowledge into previously known information
  • Ability to read PLC ladder logic
  • Ability to read P&IDs and electrical drawings

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.

Find out more on Social Media:

LinkedIn https://www.linkedin.com/company/1603/

Facebook https://www.facebook.com/astrazenecacareers/

Instagram https://www.instagram.com/astrazeneca/?hl=en

About Operations https://www.youtube.com/watch?v=gak5Ham8oUw

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 authorization and employment eligibility verification requirements.

AstraZeneca requires all US employees to be fully vaccinated for COVID-19 but will consider requests for reasonable accommodations as required by applicable law.


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