Process Engineer

at  Alexion PharmaceuticalsInc

THIS IS WHAT YOU WILL DO:

The Global Process Engineering team is responsible for technical evaluation and facility fit assessments, that support strategic sourcing decisions made by Alexion Operations. The Process Engineer works with Operations and Engineering leaders across all Alexion manufacturing sites to support the success of major capital projects, new product introductions and facility optimizations. The position requires effective cross-functional collaboration with external partners and internal stakeholders including Manufacturing Operations, Process Development & Clinical Supply (PDCS), Supply Chain, Procurement, Finance, EH&S and Quality. In addition, this team works with partners in AstraZeneca to evaluate manufacturing capacity and collaborate on projects that benefit both business units.

YOU WILL BE RESPONSIBLE FOR:

• Responsible for assessing manufacturing capability commercial manufacturing processes with in the internal and external Drug Substance, Drug Product and Finished Product network.
• Complete process mass balance and Cost of Goods (COGs) assessments across Drug Substance (DS), Drug Product (DP), Active Pharmaceutical Ingredient (API) processes and Final Packaging (FP). This includes projects across all phases of the product lifecycle, including technology transfer, process scale-up and major process improvements in commercial manufacturing processes.
• Support Supply Chain’s long-range plan by providing process Engineering and Technical input to scenario planning and strategic sourcing decisions.
• Development and maintenance of effective relationships with internal and external partners at College Park including Supply Chain, Manufacturing Technical Services, Regulatory Affairs and Finance
• Develop Design (BOD) documents and other technical documents used to support business decisions.
• Identify and support manufacturing sites with process optimization and capacity improvement projects in all areas of manufacturing (Biologics Drug Substance, Drug Product, Small Molecule, Device Combination Products and Final Packaging).
• Identify manufacturing best practices across the network and lead or participate in teams to implement best practices.
• Liase with external CMO partners on capabilities
• Liase with process development teams on future technologies