Operational Excellence Engineer

Operational Excellence Engineer

We are seeking an Operational Excellence Engineer to support continuous improvement initiatives within a regulated manufacturing environment. This individual will work cross‑functionally to identify operational inefficiencies, improve manufacturing performance, and lead projects focused on productivity, quality, cost, and process reliability.

• Lead continuous improvement projects across manufacturing and supporting operations.
• Analyze existing processes and identify opportunities to improve efficiency, throughput, quality, cost, and reliability.
• Apply Lean and Six Sigma tools such as process mapping, value stream mapping, 5S, root cause analysis, standardized work, capacity analysis, time studies, and statistical process improvement.
• Partner with Manufacturing, Quality, Engineering, Maintenance, Supply Chain, and other teams to implement sustainable process improvements.
• Support efforts to reduce waste, downtime, manufacturing deviations, process variability, and production bottlenecks.
• Develop and track operational performance metrics, including productivity, quality, yield, equipment effectiveness, cycle time, and other manufacturing KPIs.
• Lead structured problem‑solving activities and help teams identify root causes and implement effective corrective actions.
• Facilitate continuous improvement workshops, Kaizen events, and related operational excellence initiatives.
• Evaluate production workflows, equipment utilization, staffing requirements, work methods, and facility layouts to identify improvement opportunities.
• Support business cases and cost/benefit analyses for proposed operational or equipment improvements.
• Provide coaching and training on Lean, Six Sigma, and continuous improvement practices.
• Support the development and improvement of manufacturing procedures, work instructions, and other documentation used within a regulated environment.
• Manage multiple improvement initiatives while partnering with stakeholders throughout the organization.

• Bachelor's degree in Engineering, Industrial Engineering, Manufacturing Engineering, Operations, or a related field.
• 3+ years of experience in Operational Excellence, Continuous Improvement, Manufacturing Engineering, Process Engineering, or a similar role.
• Experience working within a GMP-regulated manufacturing environment.
• Pharmaceutical, biotechnology, medical device, or other regulated manufacturing experience preferred.
• Experience with sterile or aseptic manufacturing environments is highly preferred.
• Strong knowledge of Lean and Six Sigma methodologies and structured problem‑solving techniques.
• Experience with manufacturing performance metrics such as OEE, yield, cycle time, capacity, productivity, and quality performance.
• Experience leading cross‑functional process improvement projects.
• Strong analytical and problem‑solving skills with the ability to translate data into actionable improvements.
• Strong communication and project management capabilities.
• Lean Six Sigma Green Belt or Black Belt certification is preferred.
• Proficiency with Microsoft Office and experience with process‑mapping or statistical analysis tools is beneficial.