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KH

Project Engineer / Equipment Package Lead

Katalyst Healthcares & Life Sciences
๐Ÿ‡บ๐Ÿ‡ธ United States
On-site
Staff / Principal
4 months ago
  • GMP
  • Microsoft Office Applications
  • GLP
  • AutoCAD
  • Primavera
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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

Project Engineer / Equipment Package Lead ยท Katalyst Healthcares & Life Sciences

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