5+ years of project engineering experience in API pharmaceutical manufacturing
Proven experience managing equipment packages and vendor coordination
Background in clean room environments and GMP standards
Familiarity with solid waste supply systems
Experience with large design houses and external engineering partners
Proficient in Microsoft Office; AutoCAD and Primavera are a plus
Exposure to equipment turnover or CQV activities preferred
Preferred experience in peptide or GLP-1 manufacturing
Responsibilities
Lead equipment packages from design to procurement and delivery
Review vendor submittals and technical documentation
Provide technical feedback and facilitate approval workflows
Coordinate with external design teams to meet project specifications
Clarify evolving facility and utility requirements
Track procurement schedules and project milestones
Support resolution of technical issues with various stakeholders
Collaborate with cross-functional teams to address project gaps
Benefits
Work on a high-impact $700M capital project in a leading pharmaceutical company
Engage in cross-functional collaboration within a dynamic environment
Opportunities for professional growth in a highly regulated industry
Involvement in cutting-edge API manufacturing processes and technologies
Hands-on experience in a clean room environment ensuring adherence to GMP standards
Full 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
