Engineering Services _____________________

Amgen, Inc.

Objective:

To Validate new production clean-in-place process system.

Results Achieved:

• Obtained project funding via client presentations to management

• Managed project schedules around key production milestones for Phase III clinical and conformance production runs

• Coordinated input/approvals and resolved issues with engineers, manufacturing, regulatory, validation and QA staff

• Managed User & Design Requirements updates; managed installation and operational qualifications

• Conducted a reverse tracing matrix to determine any gaps in testing

• Managed the change control and work order processes

• Updated progress and managed issues while providing team leadership