Packaging Engineer III
Core
Provide technical support for routine commercial packaging operations at external Contract Manufacturing Organizations (CMOs), manage deviations and investigations, and lead technology transfer activities for pharmaceutical packaging processes.
Role type
Senior IC packaging engineer (pharmaceuticals)
Builds
Commercial packaging operations and validated packaging processes for oral solid dose and parenteral products
Domain
Pharmaceutical manufacturing and supply chain
Required skills
cGMP compliance, deviation management, technology transfer, packaging specification review, BOM authoring, change control, shipping qualification, transportation studies, regulatory submission support, CAPA management
Preferred skills
Experience with biologics and combination products, cold chain shipping knowledge, DSCSA and EU FMD familiarity, package development for new product introductions
Technologies
Gilead Quality Management system, USP, ISO, ASTM standards
Responsibilities
Provide technical support for routine commercial packaging operations at external CMOs, drive timely issue resolution to ensure product quality and regulatory compliance, collaborate with Technical Development on manufacturability and packaging design, lead or support technology transfer activities for packaging processes, review and approve specifications for primary, secondary, and tertiary packaging components, author and maintain Bills of Materials and packaging process instructions, maintain awareness of and ensure compliance with cGMP and regulatory requirements
Seniority
Senior, hands-on IC
