Process Engineer

Process EngineerLocation: North Carolina, USAJob Type: ContractDuration: 12 MonthsJob SummaryWe are seeking an experienced Process Engineer to support process development, optimization, troubleshooting, validation, and continuous improvement activities within a manufacturing environment. The ideal candidate will have experience working with production processes, process equipment, data analysis, and cross-functional teams to improve quality, efficiency, capacity, and process reliability.Key ResponsibilitiesDevelop, optimize, and scale manufacturing processes to meet production and quality requirements.Provide technical support for day-to-day manufacturing operations.Troubleshoot process and equipment issues and identify sustainable solutions.Develop and maintain process flow diagrams, SOPs, work instructions, and technical documentation.Support process characterization, process development, and process optimization activities.Lead or support process validation, qualification, and verification activities.Analyze process data to identify trends, variability, and opportunities for improvement.Perform root cause analysis for process deviations, failures, and manufacturing issues.Support CAPA, deviation, change control, and nonconformance investigations.Develop and implement process improvements to increase yield, throughput, capacity, and efficiency.Support equipment installation, commissioning, start-up, and qualification activities.Collaborate with Manufacturing, Quality, Engineering, Automation, Maintenance, and R&D teams.Support new product introduction (NPI), technology transfer, process scale-up, and manufacturing readiness.Develop and monitor process performance metrics and KPIs.Apply Lean Manufacturing and Six Sigma methodologies to improve process performance.Ensure processes comply with applicable GMP/cGMP, FDA, safety, and company requirements.Required QualificationsBachelor's degree in Chemical Engineering, Mechanical Engineering, Biochemical Engineering, Industrial Engineering, or a related field.3+ years of experience in Process Engineering or Manufacturing Engineering.Experience supporting manufacturing processes in a production environment.Strong knowledge of process troubleshooting and optimization.Experience with process validation, qualification, or process characterization.Experience with Root Cause Analysis, CAPA, deviations, and change controls.Strong analytical and problem-solving skills.Excellent communication and technical documentation skills.Ability to work effectively in a cross-functional and fast-paced environment.Preferred QualificationsExperience in pharmaceutical, biotechnology, biopharmaceutical, or other regulated manufacturing environments.Experience with upstream or downstream bioprocessing is highly preferred.Experience with chromatography systems/skids, filtration, centrifugation, buffer preparation, or bioreactors is a plus.Experience with CIP, SIP, WFI, clean steam, and process utilities is preferred.Knowledge of GMP/cGMP, FDA regulations, GAMP 5, and ASTM E2500.Experience with IQ/OQ/PQ and commissioning & qualification (C&Q).Knowledge of Lean, Six Sigma, DOE, SPC, FMEA, and process capability analysis.Experience with automation/control systems such as DeltaV, Rockwell/Allen-Bradley, or Siemens is a plus.Experience supporting facility start-up, technology transfer, or large-scale manufacturing projects.