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Project Engineer / Equipment Package Lead
Katalyst Healthcares & Life Sciences
๐บ๐ธ United States
On-site
Staff / Principal
4 months ago
- GMP
- Microsoft Office Applications
- GLP
- AutoCAD
- Primavera
4 months ago
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
- Bachelor's degree in Engineering or related technical discipline preferred
Project Engineer / Equipment Package Lead ยท Katalyst Healthcares & Life Sciences