Packaging Engineer/DP MSAT Engineer leading the development of commercial packaging processes across the Regeneron Contract Manufacturing Organization (CMO) network. Responsibilities include leading cross-functional teams through packaging process development activities and equipment qualification activities, identifying continuous improvement opportunities across the existing CMO network, and serving as a technical representative for CMO selection. Developed strong problem-solving and project management skills through experience with tech transfers to CMO’s, process validations, and investigations into quality events.

The Manufacturing Sciences and Technologies (MSAT) Packaging Engineer serves as secondary packaging design and development lead for biologic product packaging (clinical and commercial) within the production network. The Packaging Engineer also serves as a technical representative for CMO selection strategy, equipment qualification activities, and will be hands on solving issues during technology transfer and cGMP start up. The MSAT team will strive to establish best practices for technical support of cGMP manufacturing operations. The position also focuses on ensuring site to site consistency after the processes are successfully transferred, provide floor support during operations of offsite manufacturing, review process data to ensure operational consistency and provide support for investigations.

Provide support to Senior Packaging Engineer in the development of Commercial Secondary Packaging components, Raw Material Specifications (RMP), and Technical Documents (TD). Additional responsibilities include working with DP Compliance on Packaging Change Controls, and tracking packaging development status for all Commercial programs.

Packaging engineer co-op supporting global packaging department. Responsibilities included working with global CooperVision sites, communicating with suppliers, designing dielines for packaging components, and working with quality engineers to meet FDA 21 CFR part 820, 21 CFR 806, and ISO 13485 requirements. Created controlled documents, as well as protocols and reports for distribution testing and engineering studies.

Performed work in laboratories with a team of chemists. Gained field experience and an understanding of common problems and problem-solving methods, troubleshot lab equipment, and completed preparatory lab work for coworkers.