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.

The ideal candidate will bring hands-on experience applying Lean and Six Sigma methodologies in a GMP-regulated manufacturing setting. Experience within pharmaceutical, life sciences, medical device, or another highly regulated manufacturing environment is important, with exposure to sterile or aseptic operations highly desirable.

Key Responsibilities
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.
Qualifications
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.