Packaging Engineer II
Core
Provide technical support for routine commercial packaging operations at external Contract Manufacturing Organizations (CMOs) and lead technology transfer activities for pharmaceutical packaging processes.
Role type
Senior IC Packaging Engineer (Pharmaceutical Manufacturing)
Builds
Commercial packaging solutions for oral solid dose, parenteral, and biologics products
Domain
Pharmaceutical manufacturing and external contract manufacturing
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
cGMP compliance, deviation and CAPA management, technology transfer, packaging process validation, BOM authoring, shipping qualification protocols, material specification creation, change control management
Preferred skills
Cold chain shipping requirements, pharmaceutical serialization (DSCSA, FMD), new product introduction support
Technologies
USP, ISO, ASTM standards
Responsibilities
Manage deviations, complaints, and investigations related to external packaging operations; Lead or support technology transfer activities for packaging processes; Author shipping qualifications and transportation studies; Review and approve packaging component specifications; Support regulatory submissions and agency inspections
Seniority
Mid-Senior, hands-on IC
