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Engineer - Process / Projects - Operations at AstraZeneca in Frederick, Maryland

Posted in Other 30+ days ago.

Job Description:

At AstraZeneca we work together across global boundaries to make an impact and find answers to challenges. We do this with the upmost integrity even in the most difficult situations because we are committed to doing the right thing. We continuously forge partnerships that help pursue world-class medicines in new ways, combining our people's exceptional skills with those of people from all over the globe.

Welcome to Frederick biologics manufacturing facility. In Frederick, MD we make a direct contribution to treating people with cancer, respiratory and autoimmune conditions across the globe. The Frederick Manufacturing Center is also an award-winning employer and has been recognized as a 'Top 50' Business in Frederick and awarded Frederick County's 'Best Place to Work' distinction in 2015 and 2019.

The Engineer - Process / Projects is responsible for providing technical support to the manufacturing and logistics buildings at the Frederick Manufacturing Center (FMC) for troubleshooting, modifications and improvements related to process, clean-in-place, steam-in-place, washing, and sterilizing equipment systems.

What you'll do:
  • Select, design, and implement new/replacement systems as required for existing or new (tech transfer) processes, equipment, and automated systems; continuous improvement initiatives; and Asset Life Cycle Management.
  • Resolve technical issues, identifying root causes and defining corrective/preventive actions with equipment and automated systems.
  • Lead assigned change controls associated with equipment and automated systems.
  • Possess some technical skills and knowledge with biopharmaceutical operations, process/utility equipment, and automated systems.
  • Create/update equipment and automated systems operation and maintenance documentation and training materials.
  • Identify/update spare parts and preventive maintenance procedures for new/modified equipment and automated systems.
  • Support FAT, SAT, commissioning, and validation activities for assigned equipment and automated systems.

Special Skills:
  • Comfortable walking through all areas of the production module (CNC space, ISO classified rooms, grey space).
  • Knowledge of the product flow through the various production areas.
  • Basic understanding of PLC and distributed control systems, HMIs, and data historians.
  • Familiar with the operation and maintenance of process equipment in either production area:

Upstream equipment:
  • Incubators
  • Bioreactors
  • Centrifuges
  • Pasteurizer

Downstream equipment:
  • Chromatography columns
  • Viral inactivation
  • Ultrafiltration
  • Defiltrations
  • Freeze/thaw

Essential for the role:
  • Bachelor's degree required, preferred in Engineering or Life Science.
  • 2-10 years of relevant Engineering experience and 0-3 years of Pharmaceutical or other regulated industry experience.
  • Basic understanding of engineering principles (fluid dynamics, heat transfer, etc.) and how they are applied to the operation of the production equipment.
  • Familiar with the cleaning and sterilization strategy for process vessels and transfer lines.
  • Ability to use process data (i.e., temperatures, pressures, valve sequencing, etc.) to solve equipment-related issues.
  • Familiar with regulatory audit process and capable of gathering supporting documents.

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.