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Principal Subject Matter Expert, Sterile Drug Product Processing – Global Operations

Location Södertälje, Stockholm County, Sweden Job ID R-201534 Date posted 20/10/2024

Are you ready to be the technical point of reference for sterile drug product manufacturing projects? As our Sterile Drug Product (DP) Processing Principal SME, you'll be responsible for the selection, design, and startup of GMP process equipment/systems. Based in Sweden, you'll support projects across Europe and AsiaPac regions. This is your chance to build a long-term career with global knowledge and opportunities!

In Global Engineering and Real Estate (GERE) we engage in a diverse range of exciting endeavours! Our team is responsible for construction, acquiring, leading and maintaining numerous pioneering facilities and work spaces around the world. We are also providing strategic direction – assisting the business in making sound property and asset decisions, as well as integrating the newest technology. Throughout our work, we are embedding a focus on sustainability as part of AstraZeneca’s Ambition Zero Carbon (achieving zero carbon emissions in our operations by 2025 and having a carbon negative value chain by 2030). 

Your role

As a Principal SME, you'll provide technical direction and leadership to ensure the appropriate specification, design, supplier selection, and delivery of critical technical drug product packages. You'll supply overall process engineering expertise throughout the project lifecycle and provide technical support to ensure that specified performance criteria are met during start-up and early operation. You'll engage with key AZ stakeholders, gather relevant AZ specific process, product & technical information, and ensure key AZ SHE and GMP compliance requirements are reflected in the design results.

Essentials for the role

  • Associate Principal SME: Bachelor’s degree (or equivalent) in Engineering with 8 or more years’ experience in Sterile Drug Product (DP) Manufacturing operations or process design and installation
  • Principal SME: Bachelor’s degree (or equivalent) in Engineering with 10 or more years’ experience in Sterile Drug Product (DP) Manufacturing operations or process design and installation
  • In-depth technical knowledge of Sterile DP Manufacturing equipment, material transfer, and containment/isolation
  • Experience in the specification, procurement, installation, start up and commissioning of equipment in a licensed GMP pharmaceutical commercial plant
  • Ability to interact with a wide range of internal business partners and leaders
  • Experience with capital project delivery from business case development through project execution and current GMP regulations
  • Fluent communicator (written and verbal) in English

Depending on your experience this could be either an E- or an F-level role (Associate or Principal SME).

Desirables for the role

  • Lean Manufacturing certification or Six Sigma Green Belt
  • Combination Product Experience

Why AstraZeneca

At AstraZeneca, we're driven by our commitment to deliver accelerated growth and to make people's lives better. We're always working towards our ambition to deliver more medicines to patients quicker and more affordably. We're leading the way in delivering Lean processes that drive greater efficiency and speed. Sustainable practices are at the heart of what we do, ensuring we manage our environmental impact across all our activities and products. If you have the passion and the drive to accelerate growth and make people's lives better, then this is the place for you.

Ready to make a positive impact in a team where it means more, excellent - welcome with your application no later then November 10th.

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.

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Great culture, great work assignments, supportive management. Rotation opportunity within the company. They value inclusion and diversity.