NC - Project Engineer, Pharma Process Engineering Greenfield

The Spear Group Full-Time Opportunity with Corporate Benefits

Position:

Project Engineer - Pharma Greenfield Project - Drug Product Manufacturing/Process Engineering

Location:

Eventual Facility Project Construction Site Location in Raliegh/Durham NC Immediate Area -- Per Diem/Travel & Lodging Monthly Stipend Available for Travelers

Position starts full time on site in the Greater Philadelphia, PA Area during design until approx., June 2026 (design phase work in PA w/ travel expense coverage)

Position Summary:

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 client's 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.

Key Responsibilities:

1. Be the Owner's Rep on behalf of the pharma client's project engineering delivery team.
2. 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. Activities may include, yet are not limited to the following:
   1. Attending equipment design meetings with equipment vendors
   2. Responding to equipment vendor submittals to ensure compliance with project design drawings, specifications, and user requirements.
   3. FAT execution, write-up, and review using existing documentation and protocols.
   4. Coordinate process equipment receipt verification.
   5. Working with internal and external pharma client/owner's project partners to ensure activities related to the core processing systems equipment installation and startup are aligned with the design.
   6. Equipment start-up and troubleshooting.
   7. Equipment and related clean utility C&Q execution, write-up and review using existing documentation and protocols.
   8. Turn over package (TOP) management.
   9. Deviation management.
   10. Equipment installation support and coordination with project General Contractor and Construction Manager
   11. Analytical equipment procurement, installation, start-up, and C&Q.
   12. Work with pharma client/owner Automation engineering team to facilitate coordination of control systems design, installation, and commissioning needed for the core processing systems.
   13. Vendor document and change requests management.

The following process systems are in the Scope of Service:

• Buffer Prep, Compounding, filling tanks
• Utility Panel associated with the Compounding and Filling area
• Syringe Filling System
• Automated Visual Inspection System
• CIP/SIP
• Analytical and benchtop equipment

Hours of work:

• 40 hours a week at the co-location site in the greater Philadelphia, PA area. After June2026, travel expenses to PA will not be needed as work will be at the facility project site in North Carolina and full time work presence will be in NC.
• Travel to be facilitated and approved by pharma client / owner's travel policy process.

Required Experience and Education:

• 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

Compensation based on relevant experience

EQUAL OPPORTUNITY EMPLOYER

The Spear Group, Inc. is an Equal Opportunity Employers. All personnel actions are affected without regard to race, color, sex, age, religion, national origin, disability, veteran status, or other protected status pursuant to law. As a responsible organization, we resolutely support the concept and practice of Equal Employment Opportunity. We uphold federal, state, and local civil rights laws and work to ensure that all of our personnel actions and policies are in compliance. Additionally, we recognize and value the importance and diversity of our work force and support its various cultures. The Companies are dedicated to fostering an environment that respects the dignity, rights and contributions of our employees.

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