NC - Project Engineer, Pharma Process Engineering Greenfield

The Spear Group•Raleigh, NC

15d•Onsite

About The Position

The Spear Group has an exciting career opportunity for an experienced and knowledgeable Pharma Manufacturing Process Engineer / Project Engineer to support our top tier, global pharma manufacturer client with their greenfield project in the Raleigh/Durham NC area. This is a great opportunity to be on a greenfield project end to end starting with detailed design. The ideal Project Engineer will provide project engineer support in executing the delivery of core drug product unit operations / facilities (i.e. Compounding, Buffer Prep, CIP/SIP, Syringe Filling, Automated Visual Inspection, Equipment Prep, and Analytical Equipment) to the clients greenfield project during detailed design phase at a site outside of Philadelphia, PA and at the project site location in the immediate Raleigh/Durham, NC area. The selected Project Engineer is expected to be on-site at the designated project co-location site in the greater Philadelphia, PA area until thru June 2026, then to the designated project co-location site in Holly Springs, North Carolina thereafter for the duration of the assignment. Corp pharma client travel process will facilitate travel to PA.

Requirements

Bachelor of Science Degree in chemical engineering or mechanical engineering or related engineering.
4-10 years of experience in pharmaceutical manufacturing CAPEX projects, Drug Product manufacturing, or device and packaging

Responsibilities

Be the Owners Rep on behalf of the pharma clients project engineering delivery team.
Work closely with the core project team throughout the project phases of the project until completion of equipment and automation C&Q confirming core processing equipment and facilities are aligned with IFC drawings and other design documents.
Attending equipment design meetings with equipment vendors
Responding to equipment vendor submittals to ensure compliance with project design drawings, specifications, and user requirements.
FAT execution, write-up, and review using existing documentation and protocols.
Coordinate process equipment receipt verification.
Working with internal and external pharma client/owners project partners to ensure activities related to the core processing systems equipment installation and startup are aligned with the design.
Equipment start-up and troubleshooting.
Equipment and related clean utility C&Q execution, write-up and review using existing documentation and protocols.
Turn over package (TOP) management.
Deviation management.
Equipment installation support and coordination with project General Contractor and Construction Manager
Analytical equipment procurement, installation, start-up, and C&Q.
Work with pharma client/owner Automation engineering team to facilitate coordination of control systems design, installation, and commissioning needed for the core processing systems.
Vendor document and change requests management.