Operational Excellence Engineer II
Operational Excellence Engineer II
Location: Windsor, CO (Onsite)
Schedule: Monday-Friday, 8:00 AM-5:00 PM
Overview
Our client is seeking an Operational Excellence Engineer II to drive continuous improvement initiatives across pharmaceutical manufacturing and quality operations. This role will focus on improving productivity, quality, compliance, and cost efficiency within a GMP-regulated environment, with a strong emphasis on aseptic and sterile manufacturing processes. The ideal candidate will leverage Lean and Six Sigma methodologies to reduce waste, optimize workflows, improve throughput, and support operational excellence.
Key Responsibilities
- Lead process improvement initiatives focused on productivity, quality, cost savings, and operational efficiency.
- Analyze manufacturing workflows using Lean and Six Sigma tools, including Value Stream Mapping, 5S, TPM, OEE analysis, capacity planning, and cycle time reduction.
- Develop and track KPIs, dashboards, and performance metrics to support business objectives.
- Facilitate root cause investigations, CAPA effectiveness initiatives, and cross-functional problem-solving sessions.
- Lead Kaizen events and continuous improvement projects across Manufacturing, Quality, Engineering, Supply Chain, and Maintenance.
- Conduct ROI and business impact analyses for process and equipment improvement opportunities.
- Support GMP documentation updates, SOP improvements, batch record enhancements, and process standardization efforts.
- Train and mentor employees on Lean principles and continuous improvement methodologies.
Qualifications
- Bachelor's degree in Engineering, Operations Management, Industrial/Manufacturing Engineering, or a related field.
- 3+ years of experience leading Operational Excellence or Continuous Improvement initiatives in pharmaceutical or other GMP-regulated manufacturing environments.
- Strong knowledge of Lean Manufacturing and Six Sigma methodologies; Green Belt or Black Belt certification preferred.
- Experience with GMP compliance, FDA regulations, CAPA, deviation reduction, and process optimization.
- Familiarity with aseptic processing, sterile manufacturing, cleanroom operations, and contamination control is strongly preferred.
- Proven ability to manage projects, analyze data, drive change, and work cross-functionally.
- Proficiency with Microsoft Office Suite, Visio, and data analysis tools such as Minitab, JMP, AutoCAD, or similar software.
FAQs
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