Project Engineer / Equipment Package Lead

Katalyst CRO; Boulder (CO); On-site; USD 80,000 - 120,000; Full time

Job summary

Katalyst CRO is seeking a Project Engineer / Equipment Package Lead in Boulder, Colorado. This role involves supporting a $700M API facility project and managing equipment packages through design, procurement, and delivery while coordinating with various stakeholders.

The ideal candidate will have over 5 years of project engineering experience in a GMP-regulated pharmaceutical manufacturing setting and be proficient with vendor coordination. A Bachelor’s degree in Engineering or a related field is preferred.

Qualifications

• 5+ years of project engineering experience supporting large CAPEX projects in API pharmaceutical manufacturing environments.
• Experience managing equipment packages and vendor coordination.
• Familiarity with GMP-regulated manufacturing facilities and clean room environments.

Responsibilities

• Lead assigned equipment packages from design through procurement and delivery.
• Review vendor submittals, technical drawings, and engineering documentation.
• Collaborate with process, facilities, utilities, and operations teams.

Skills

Project engineering experience

Vendor coordination

Technical submittal reviews

Proficiency in Microsoft Office

Familiarity with GMP and clean room standards

Education

Bachelor's degree in Engineering or related technical discipline

Tools

AutoCAD

Primavera

Job description

Job Summary

• Support a $700M API facility capital project as a Project Engineer / Equipment Package Lead within a GMP-regulated pharmaceutical manufacturing environment
• Lead equipment packages through design, procurement, and delivery while coordinating with vendors, site stakeholders, and external engineering partners
• Drive package engineering activities, resolve technical issues, and ensure alignment with project schedules and facility requirements
• Work in a fast-paced clean room manufacturing environment with evolving specifications and cross-functional collaboration

Roles & Responsibilities

• Lead assigned equipment packages from design through procurement and delivery
• Review vendor submittals, technical drawings, and engineering documentation
• Provide technical comments and support approval workflows for vendor deliverables
• Coordinate with external design houses to ensure package scope and deliverables meet project requirements
• Gather and clarify process, facility, utility, and site requirements where specifications are incomplete or evolving
• Track package milestones, procurement schedules, and key project deliverables
• Support technical issue resolution across vendors, engineering teams, and site stakeholders
• Collaborate with process, facilities, utilities, and operations teams to close technical and project gaps
• Maintain alignment with GMP and clean room facility standards

Experience

• 5+ years of project engineering experience supporting large CAPEX projects in API pharmaceutical manufacturing environments
• Experience managing equipment packages, vendor coordination, and technical submittal reviews
• Experience working with solid waste supply systems
• Familiarity with GMP-regulated manufacturing facilities and clean room environments
• Experience working with large design houses and external engineering partners
• Proficiency in Microsoft Office applications
• Exposure to equipment turnover, startup, or CQV activities preferred
• Peptide or GLP-1 manufacturing experience preferred
• Familiarity with AutoCAD and Primavera is a plus

Education

• Bachelor's degree in Engineering or related technical discipline preferred