Packaging Engineer III
Core
Develop, qualify, and support primary, secondary, and tertiary packaging systems for oral solid dose, biologics, and drug-device combination products to support product development and clinical study supplies.
Role type
Mid-level individual contributor packaging engineer
Builds
Primary, secondary, and tertiary packaging systems for pharmaceutical products
Domain
Pharmaceutical manufacturing and regulatory compliance
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Pharmaceutical packaging development, container-closure systems, component characterization, shipping qualification, cGMP principles, regulatory documentation, cross-functional collaboration
Preferred skills
Experience with OSD packaging systems, biologics packaging requirements, drug-device combination products, industry standards (USP, ISO, ASTM)
Technologies
USP, ISO, ASTM
Responsibilities
Execute packaging development activities for OSD, biologics, and combination products; Apply pharmaceutical packaging principles for system development and qualification; Support regulatory submissions with documentation; Perform component characterization and qualification; Execute shipping qualification activities; Support equipment and process qualification (IQ/OQ/PQ); Provide technical support for deviation investigations and change controls; Author and review technical documentation; Ensure compliance with cGMP and quality system requirements
Seniority
Mid-level individual contributor
