Senior Process Engineer

The Alexion Technical Operations team support Alexion’s global Alexion’s global manufacturing operations across both internal and external sites. The Process Engineer is part of the Technical Operations group and is responsible for providing technical engineering support across all Alexion Operations.

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.
• Leads the Early Engagement process, supporting all new product Introductions into internal manufacturing sites.
• Leads the implementation of digital standards and digital tools in the Process Engineering team. Focusing on tools that provide computational Fluid Dynamics (CFD) and capacity and capability models.
• Mentor junior engineers across internal sites; provide training on modelling, COGs and facility fit methodologies; contribute to building the internal SME community
• 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.
• Liasie with external  CMO partners on capabilities
• Liasie with process development teams on future technologies

You will need to have:

• Technical expertise: Apply comprehensive process engineering knowledge to complex problems; independently designs and validates models and assessments; ensures compliance with cGMP standards.
• Problem solving and decision making: Use data‑driven analysis to evaluate options, quantify trade‑offs and recommend pragmatic solutions; comfortable with ambiguity and complexity.
• 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 Product and/or Drug Substance manufacturing sites.