Principal Continuous Improvement Engineer

Overview

We are seeking a Principal Continuous Improvement Engineer to lead enterprise-wide operational excellence initiatives across development, manufacturing, and compliance functions within a global radiopharmaceutical manufacturing organization. The role focuses on driving Lean Six Sigma strategy, reducing cycle time, and enabling scalable, data-driven process performance across multi-site GMP operations.

Key Responsibilities

• Lead end-to-end continuous improvement strategy across manufacturing, development, and quality/compliance systems using Lean Six Sigma methodologies.
• Drive high-impact improvement initiatives including Kaizen events, root cause analysis, and rapid response teams for complex operational and quality issues.
• Apply advanced statistical tools, DOE, and data analytics to identify process variability, optimize manufacturing performance, and accelerate product lifecycle timelines.
• Develop and implement standardized systems, governance models, and KPI frameworks to sustain operational excellence across multiple functions and sites.
• Partner with cross-functional leadership to execute strategic improvement programs that enhance efficiency, compliance, and cost performance in GMP-regulated environments.
• Support inspection readiness and ensure alignment with FDA, EMA, and other global regulatory requirements across all operational activities.

Job Qualifications

• B.S. in Engineering, Chemistry, or related scientific discipline required.
• 12+ years of experience in pharmaceutical, biotech, or regulated manufacturing environments.
• Strong background in Lean Six Sigma (Black Belt preferred) with demonstrated success leading enterprise-level improvement initiatives.
• Advanced problem-solving, statistical analysis, and project leadership skills required.
• Proven ability to lead cross-functional teams in high-pressure, fast-paced GMP environments with multiple concurrent priorities.
• Strong communication skills with the ability to translate technical findings into executive-level insights.
• Experience across multiple functional areas such as manufacturing, finance, development, technical transfer, supply chain, or compliance in addition to the core position requirements.