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Validation Engineer II - Operations - Gaithersburg, MD

地点 盖瑟斯堡, 马里兰州, 美国 职位 ID R-105291 发布日期 04/13/2021

Validation Engineer II- Operations- Gaithersburg, MD

Would you like to apply your expertise to impact the Quality Operations in a company that follows the science and turns ideas into life changing medicines? AstraZeneca is a science-driven biopharmaceutical company with a pipeline of exciting new medicines with an array of modalities. We are dedicated to discovering, developing, and delivering innovative, meaningful medicines and healthcare solutions that enrich the lives of patients.  

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.  Come and thrive in our vibrant, energizing, connected and encouraging culture and make a difference to patients. Hear from our Senior Leaders about why they know AstraZeneca is a great place to work. https://lnkd.in/g8APibK

The Validation Engineer provides technical and system support to Development Quality Biologics, BPD and Facilities.  This individual will review and approve 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.

Main Responsibilities:

  • Review and approve validation protocols and reports.  Execute validation protocols and work with validation and metrology contractors when required.
  • Maintain an up-to-date knowledge of validation requirements, practices and procedures.
  • Partners with manufacturing sciences and facilities / engineering departments to facilitate qualifications and validations, as necessary.
  • Communicate effectively with supervisor and other departments workload, priorities, and issues to maintain validation schedule.
  • Provides technical solutions to a wide range of issues of mild and moderate scope and complexity.  Manage multiple projects concurrently.
  • Contributes to the completion of milestones associated with projects and Quality Records

Minimum Requirements:

  • B.S. in Engineering or Technical Field.
  • Minimum of three (3) years’ experience in biopharmaceutical or 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.

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 authorisation and employment eligibility verification requirements.

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