Operational Excellence Engineer

Operational Excellence Engineer

Requirements

• Bachelor’s degree in a relevant field such as Biotechnology, Engineering, Manufacturing or Operations Management; advanced degree preferred.
• 3-5 years of experience in manufacturing or operations optimization, preferably in a regulated environment (e.g., pharmaceuticals, medical devices, or biotechnology).
• Required: Lean certification (minimally green belt certified) – Including demonstrated experience applying Lean, Six Sigma, and other operational excellence methodologies to manufacturing operations.
• Experience with data analysis, process optimization, and implementation of KPIs and performance metrics.
• Understanding of cell therapy manufacturing processes, regulatory requirements (GxP, GMP, FDA, EMA), or related industry standards.
• Proficient in data analysis tools (Excel, Minitab, etc.), statistical process control (SPC), and process modeling techniques.
• Strong understanding of Lean, Six Sigma, and other continuous improvement methodologies, certification a plus.
• Excellent analytical, problem-solving, and troubleshooting skills.
• Strong project management skills, with the ability to handle multiple projects simultaneously.
• Excellent written and verbal communication skills, with the ability to present data and findings to leadership and cross-functional teams.

Responsibilities

• Lead and implement continuous improvement initiatives aimed at optimizing manufacturing processes. Use Lean, Six Sigma, and other operational excellence tools to streamline production workflows, reduce waste, and increase overall efficiency.
• Define, implement, and monitor key performance indicators (KPIs) that track the efficiency, quality, and effectiveness of manufacturing operations. Develop dashboards and reporting tools to ensure real-time visibility into process performance.
• Collect and analyze data related to production metrics, production performance, cycle times, etc. Identify trends and areas of improvement and use data to drive decision-making for process enhancements.
• Work closely with operations, engineering, quality, and supply chain teams to understand challenges, identify bottlenecks, and optimize processes across departments. Facilitate communication between teams to ensure alignment on improvement initiatives.
• Lead projects aimed at improving manufacturing processes and performance. Manage project timelines, budgets, and resources to ensure successful completion.
• Ensure all manufacturing optimization activities comply with industry standards and regulations (e.g., GMP, ISO). Work closely with the quality team to ensure that improvements maintain or enhance product quality and safety.
• Foster a culture of continuous improvement within the organization, encouraging employees to contribute ideas, solve problems, and implement solutions that drive operational excellence.

Preferred Qualifications

• Advanced degree preferred.
• Strong understanding of Lean, Six Sigma, and other continuous improvement methodologies, certification a plus.