Manufacturing Engineer - II*

The Manufacturing Engineer supports manufacturing data analysis, reporting, and verification, and assists with tech transfers and MSAT lab activities as needed. The role focuses on Stage 3 Process Validation through a robust Continued Process Verification (CPV) program, including monitoring process performance trends, assessing sources of variability, and ensuring manufacturing processes remain in a sustained state of control. Additional responsibilities include the design, modification, and maintenance of manufacturing equipment and processes, as well as engineering planning, scale‐up activities, process improvements, and validation.The engineer conducts equipment and system evaluations, performs troubleshooting to resolve technical issues, and generates or reviews key engineering and manufacturing documentation (e.g., SSPD, SOPs). The role also collaborates with cross‐functional teams to support process changes, equipment qualification, and implementation of new technologies.Additionally, the engineer supports procurement activities for the non‐GMP MSAT lab by sourcing equipment, materials, and services that align with manufacturing equipment requirements and operational needs. This includes evaluating vendor capabilities, obtaining quotes, coordinating purchases, and ensuring timely delivery and installation to support ongoing MSAT lab operations.