5445 Project Engineer I

Duties:
The Clinical Supply Center project team is seeking contract support for the commissioning and qualification of a state of the art single use manufacturing facility.
The successful applicant will have the opportunity to work with a talented team of manufacturing specialists and process engineers and will support facility startup.
The work will be performed on site in with some flexibility for remote work.

Primary Responsibilities:
Manage Engineering Changes associated with the startup and commissioning of single use process equipment.
Own/Manage Change records for new material introductions and procedure/SOP updates.
Support execution of commissioning testing of process equipment in the new manufacturing facility as needed.
Support Senior members of the team by performing data collection and analysis, compiling data and systems information and providing recommendations.
Correspond with vendors for purchase of ancillary manufacturing furnishings, parts, and equipment.

Skills:
GMP experience and solid understanding of Good Documentation Practices (GDP).
Experience managing GMP change records in Trackwise.
Commissioning/Qualification experience a plus.
Working knowledge of cell culture or purification processes and equipment.
Strong initiative and self starter.
Excellent Collaboration and Communication skills.
Project Management Experience a plus (including use of Smartsheet/Gant Chart tools).

Education:
Education and Experience B.S. in Engineering (Chemical, Mechanical, Electrical preferred), Science or equivalent is required.