Outstanding opportunity for a Senior Project Engineer (Manager level) to join our big pharma client at their plant which produces Bulk Drug Substance and Fill/Finish processes. The chosen candidate must come out of this type of environment and be well versed in the core principles of various related engineering disciplines which will include cell culture/purification/aseptic filling/packaging/cGMP facility design AND utilitiy systems (WFI/clean steam/compressed gases/HVAC). Should be considered an SME in these areas.
Experience in the planning and execution of all engineering functions for current and growth capital projects.
Will function as an engineering technical lead including definition of project scope, RFQ/RFPs for bidding and selection of capital projects. Will prepare and or support cost estimates, budgets and project schedules for capital projects.
Will interface closely with Project Managers to manage capital project funding requests including project execution planning.
Should have a demonstrated track record of successfully executing technical projects in an FDA regulated manufacturing environment. Must have experience in biopharmaceutical process/equipment sanitary design principles and materials of construction.
Knowledge of programmable logic controllers (PLCs), instrumentation and controls is highly desirable.
BS in Mechanical, Chemical or Biomedical Engineering with 15 years in a pharmaceutical or biotech company with 5+ years in executing capital projects. Six Sigma Green Belt/Black Belt Certification is preferred.