Sara Alonso

Lead CMC program management using best practices to deliver complex programs on scope, budget, and timeline while aligning cross-functional and senior management stakeholders.

Managed a team of six engineers, ensuring training, development, regulatory compliance, and providing technical leadership during inspections and manufacturing support.

Managed scope, schedule, budget and quality of cGMP engineering projects for process equipment, piping, and controls, and led design reviews, installations, and corrective actions.

Investigated process deviations and production issues, supported cost-reduction projects and performed continuous process monitoring to mitigate product impact.

Provided engineering support and led start-up and validation activities (IQ/OQ/PQ) for PWEC, CIP, buffers and glycol systems for a new Humalog® manufacturing operation.

Performed process, packaging and cleaning validations, investigated deviations, and led research projects for reformulations and process improvements.

Served as technical expert for purification systems, supporting troubleshooting, change control, Maximo/P&ID updates and GMP documentation for manufacturing equipment.

Applied Lean tools and metrics to map processes, lead Kaizen events, and implement improvements that increased operational efficiency and effectiveness.

Completed a Master’s in Engineering with a focus on Manufacturing Engineering, emphasizing manufacturing systems and process optimization.

Completed a Bachelor of Science in Chemical Engineering covering process engineering, validation, and pharmaceutical-related unit operations.