Project Engineer
Core
Lead technical definition, design, and delivery of facility, utility, and equipment projects within a cGMP commercial manufacturing environment.
Role type
Senior Project Engineer (Facility/Utilities/Equipment)
Builds
Facility infrastructure, utility systems, and manufacturing equipment
Domain
Biopharmaceutical manufacturing / cGMP regulated environment
Required skills
cGMP manufacturing knowledge, engineering design, feasibility studies, technical specifications, risk management, change control, CAPA, root cause analysis, vendor management, regulatory compliance
Preferred skills
AutoCAD, Revit
Technologies
AutoCAD, Revit
Responsibilities
Lead technical definition, design, and delivery of facility, utility, and equipment projects; Translate business needs into engineering concepts and technical solutions; Lead feasibility studies and option assessments; Develop or coordinate technical specifications, design requirements, and tender packages; Review and challenge designs, calculations, and drawings from engineering partners and vendors; Ensure compliance with cGMP, EHS, and regulatory requirements; Own technical input to engineering assessments, Change Controls, and risk assessments; Monitor contractor execution and acceptance of deliverables; Lead technical troubleshooting and root cause analysis; Manage engineering documentation and drawings; Contribute to site engineering standards and knowledge sharing.
Seniority
Senior, hands-on IC