Title: Engineer Senior /Project Engineer

Location: New Albany, OH

Duration: 12+Months.

Description:

00% onsite for OH New Albany site.

Top 3 Must Have Skill Sets:

Project Management,

communication,

work in teams

Ideal candidate: supporting process development. needs to have a biotech, med device, pharmaceuticals wants them to bring 5 years of experience. Experience with GMP environment Technical degree preferred: Engineering open to chemical, mechanical, etc. Candidate should showcase they have executed projects took ownership full lifecycle. Ideally smart sheets, MS Project, or other PM tools.

As a member of the Amgen Ohio, Process Development organization, this role serves as project manager for Final Drug Product New Process Introductions (NPI) into Amgen Ohio. NPI scope may include the implementation of various drug product formats (e.g. vial, syringe, auto injectors, etc.), introduction of new processes and equipment (including medical device final assembly and testing), and implementation of new packaging configurations.

The Project Manager engages Final Drug Product development teams throughout the commercialization process, leading cross-functional NPI teams with support from Manufacturing, Supply Chain, Quality, Engineering, Process Development and other business groups.

Primary responsibilities include assessment of NPI s for necessary process, facility, equipment, materials, and training modifications; development of project execution plans; ensuring process requirements are effectively transferred into manufacturing; and coordination/execution of NPI activities, which may include document preparation or revision, change control management, manufacturing process modifications, equipment and technology implementation (design through qualification), and supporting manufacturing readiness activities.

Basic Qualifications

Doctorate degree OR Master degree and 3 years of experience OR Bachelor degree and 5 years of experience OR Associate degree and 10 years of experience OR High school diploma / GED and 12 years of experience