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Process Engineer - New Technology & Innovation - Gaithersburg, MD - Global Operations

Lieu Gaithersburg, Maryland, États-Unis Job ID R-121726 Date de publication 11/01/2021

Process Engineer- New Technology & Innovation (Biologics)- Gaithersburg, MD

At AstraZeneca, we turn ideas into life changing medicines. Working here means being entrepreneurial, thinking big and working together to make the impossible a reality. We're focused on the potential of science to address the unmet needs of patients around the world. We commit to those areas where we think we can really change the course of medicine and bring big new ideas to life.

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. 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.

In Biologics Global Technical Operations (GTO), we work closely with AstraZeneca’s manufacturing network of internal sites and external manufacturing partners (CMOs), our colleagues in R&D, Quality, Regulatory, Supply Chain, and Commercial to provide technical leadership to ensure delivery of quality products to our patients and support our product pipeline. The Process Engineer (Sr PE) for New Technology and Innovation is an energetic, self-motivated and innovative individual who possesses skills required to successfully align, develop and execute new technology projects in a collaborative, customer focused manner.

What you’ll do:

  • Build business cases, develop data packages and support implementation of new applications and/or technologies at manufacturing sites.
  • Gather and understand business needs and work with CMC technical teams, manufacturing and testing sites (internal and external) and process development to collaboratively develop solutions.
  • Support the development and maintenance of the manufacturing technology strategy and roadmap.
  • Stay abreast of the latest technologies used in the manufacture of biopharmaceuticals with the awareness of the needs of Operations.
  • Develop cost modeling and business case in support of conveying the value of new strategies and new technologies.
  • Facilitate communication and alignment of Development and Operations technical decisions on technology strategy including presentations to peer level and senior management.
  • Drive implementation of new technology across the network per the strategy roadmap.
  • Connect with vendors of new technology packages to develop detailed implementation plans.
  • Develop and implement new technologies across drug substance and drug product/ device manufacturing and analytical testing operations in a collaborative manner with key stakeholders.
  • Facilitates alignment of Development and Operations technical decisions on new technology implementation including presentations to peer level and senior management.
  • Create technology development packages to evaluate new technologies or materials including test plan development and laboratory execution to confirm manufacturer claims and ensure quality, performance and safety requirements are met.

Essential for the role:

  • B.S. in Engineering, Physical Sciences, or equivalent focus of study. Master’s degree preferred.
  • Minimum of four (4) years of experience with a strong understanding of biologic manufacturing process.
  • Ability to work on multiple projects and drive project completion.
  • Demonstrated strong mechanical, analytical and technical skills.
  • Strong interpersonal, collaboration and communications skills.
  • Comfortable integrated new technology into existing GMP manufacturing environments.
  • Prior experience in leading/participating in implementation of new technology in a MFG setting a plus.

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, groundbreaking 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 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.

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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