Production Process Engineer

Job Title: Production Process Engineer Location: Asheville, NC Duration: Long Term Position Overview We are seeking an experienced Production Process Engineer to support manufacturing operations by optimizing production processes, improving operational efficiency, and ensuring product quality within a regulated pharmaceutical or medical device manufacturing environment. The ideal candidate will have experience in process optimization, manufacturing support, GMP compliance, data analysis, and cross-functional collaboration to drive continuous process improvements. Key Responsibilities Optimize production and manufacturing processes to improve efficiency, productivity, and product quality. Monitor manufacturing process performance and identify opportunities for process improvements. Analyze production data, investigate process trends, and implement corrective and preventive actions. Ensure compliance with GMP, FDA regulations, ISO standards, and internal quality system requirements. Collaborate with Production, Manufacturing, Engineering, Quality Assurance, and Validation teams to support daily manufacturing operations. Troubleshoot production issues, perform root cause analysis, and implement sustainable process improvements. Develop and update process documentation, SOPs, work instructions, and manufacturing procedures. Support process validation, equipment qualification, and technology transfer activities. Participate in Lean Manufacturing, Six Sigma, and continuous improvement initiatives to reduce waste and improve operational performance. Assist with deviation investigations, CAPA implementation, change control, and regulatory audit readiness. Required Qualifications Bachelor's degree in Mechanical Engineering, Chemical Engineering, Industrial Engineering, Manufacturing Engineering, or a related engineering discipline. Experience in pharmaceutical, biotechnology, or medical device manufacturing environments. Strong knowledge of production process optimization, manufacturing systems, and process improvement methodologies. Familiarity with GMP, FDA regulations, ISO standards, and regulated manufacturing practices. Experience analyzing manufacturing data, identifying process improvements, and implementing corrective actions. Knowledge of process validation, equipment qualification, and manufacturing documentation. Strong analytical, troubleshooting, problem-solving, and decision-making skills. Excellent communication, technical documentation, and cross-functional collaboration abilities. Experience with Lean Manufacturing, Six Sigma, or continuous improvement methodologies is preferred. Familiarity with MES, ERP systems, statistical process control (SPC), and manufacturing KPIs is an added advantage. LinkedIn: #J-18808-Ljbffr