Process Engineer

Required Skills5+ years of Process Engineering experienceMedical Device or Pharmaceutical Manufacturing backgroundManufacturing Process Development & OptimizationProcess Validation (IQ/OQ/PQ)Equipment Qualification & InstallationStatistical Process Control (SPC)Statistical Data Analysis (Minitab preferred)Yield Improvement & Continuous ImprovementRoot Cause Analysis (RCA) & CAPADesign Transfer / New Product Introduction (NPI)Experience working with R&D, Quality, Manufacturing & OperationsKnowledge of FDA, GMP, ISO 13485 regulated environmentsStrong documentation and technical communication skills