Process Engineer

3 weeks ago


Dublin, Dublin City, Ireland Alexion Pharmaceuticals Full time

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

You will need to have:

Experience in Manufacturing Operations, Technical Support or Equipment Engineering in a biopharmaceutical company. Knowledge of a biological manufacturing processes drug product or drug substance Knowledge of Process Engineering principles and standards used in cGMP manufacturing Strong problem solving and troubleshooting capability Good Presenting and Training Skills Good Technical writing skills Organized analytical thinker with strong attention to detail Excellent communications and decision-making skills Confirmed ability to work well as part of a team & on own with minimum supervision

We would prefer for you to have:

Bachelors' degree in Engineering (Chemical, Biochemical) or related field. Experience working in a technical Engineering role in a Drug Substance and/or Drug Product manufacturing sites.

Date Posted

22-May-2024

Closing Date

11-Jun-2024Our mission is to build an inclusive and equitable environment. We want people to feel they belong at AstraZeneca and Alexion, starting with our recruitment process. We welcome and consider applications from all qualified candidates, regardless of characteristics. We offer reasonable adjustments/accommodations to help all candidates to perform at their best. If you have a need for any adjustments/accommodations, please complete the section in the application form.
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