Operational Excellence Engineer II (Onsite)
About The Position
The Operational Excellence Engineer II is a member of the Operational Excellence core team and drives productivity, compliance, and cost effectiveness across pharmaceutical Manufacturing and Quality Operations. The role helps establish a culture of continuous improvement and customer value by analyzing manufacturing and related Quality Assurance processes in a GMP-regulated environment, with particular emphasis on aseptic and sterile manufacturing. The engineer identifies and implements improvements using Lean and Six Sigma methods to simplify processes, improve quality, reduce deviations and waste, increase throughput, and support reliable pharmaceutical product supply. The position works across manufacturing, maintenance, warehouse, quality, engineering, validation, and supply chain. It analyzes process performance, develops metrics and reports, leads improvement projects and workshops, supports compliant documentation, and provides training to strengthen continuous improvement capabilities. The role is onsite in Windsor, Colorado, with core hours Monday through Friday, 8:00 a.m. to 5:00 p.m. Work may include controlled cleanroom areas requiring gowning and adherence to aseptic behavior and sterile manufacturing practices.
Requirements
- Bachelor of Science in Engineering, Operations Management, Industrial/Manufacturing Engineering, or a related field.
- At least 3 years of experience leading process improvement and operational excellence initiatives in pharmaceutical manufacturing or another GMP-regulated manufacturing environment.
- Strong understanding and application of Lean and Six Sigma methodologies.
- Understanding and experience working in a Lean culture supporting continuous improvement in a GMP-regulated pharmaceutical manufacturing environment.
- Project management and planning skills, including the ability to independently manage timelines, resources, and milestones for process improvement initiatives.
- Ability to work independently with limited supervision and collaborate with employees at all organizational levels.
- Strong interpersonal communication, problem-solving, and organizational skills, including the ability to engage people outside direct management.
- Knowledge and application of line balancing, manning calculations, productivity and loss analysis, capacity analysis, ergonomic risk analysis, time studies, standardized work, PFMEA, Lean manufacturing, and statistical process control in regulated manufacturing.
- Familiarity with aseptic processing principles, contamination control strategy, cleanroom practices, and sterile manufacturing controls.
- Working knowledge of pharmaceutical manufacturing metrics such as OEE, yield, batch cycle time, right-first-time, schedule attainment, and deviation trends, and familiarity with FDA, cGMP, and data integrity expectations.
- Proficiency with Visio, Microsoft Word, Excel, and PowerPoint; some experience with 2D/3D CAD and statistical analysis software such as AutoCAD, SolidWorks, Minitab, or JMP.
- Detail orientation and ability to analyze information, create metrics, and connect results to business needs and objectives.
- Ability to motivate, influence, and lead others with or without direct supervisory authority.
- Demonstrated ability to achieve process improvements and positive change; self-directed interest in leading teams and projects.
Nice To Haves
- Experience in aseptic or sterile manufacturing operations is strongly preferred.
- Lean/Six Sigma Green Belt or Black Belt certification is strongly preferred.
- Experience with low-volume, high-changeover manufacturing in pharmaceutical, biologics, medical device, or other GMP-regulated environments; direct support of aseptic or sterile manufacturing operations is preferred.
Responsibilities
- Identify and execute opportunities for cost savings, increased throughput, improved schedule adherence, and workflow optimization while maintaining compliance, product quality, contamination control, and patient safety.
- Conduct workflow analyses, time studies, and data collection; apply Lean and Six Sigma tools to improve and standardize GMP-regulated processes and deploy best practices across manufacturing and related functions.
- Develop process analyses, KPIs, scorecards, and dashboards covering resource utilization, batch release readiness, deviation trends, CAPA effectiveness, yield, scrap, process efficiency, and aseptic/sterile manufacturing indicators.
- Develop and present productivity and performance reports, dashboards, and presentations for leadership and stakeholders.
- Facilitate cross-functional problem-solving workshops to support root cause investigations, reduce recurring deviations, strengthen CAPA implementation, and improve process robustness.
- Organize and facilitate Kaizen events focused on People, Safety, Quality, Delivery, and Costs.
- Design or improve work areas and layouts to support ergonomics and reduce repetitive motion and inefficient methods.
- Promote and apply the DMAIC process improvement approach across operations.
- Assess business value, impact, and ROI for process and equipment improvements; lead, mentor, and execute multiple improvement projects and initiatives.
- Conduct Lean and technical training to increase engagement, build capabilities, and embed Lean skills across operations.
- Assist in creating and revising GMP documentation, including work instructions, SOPs, aseptic technique and cleanroom behavior documentation, batch records, protocols, specifications, and reports.
- Perform other related duties as assigned.
Benefits
- Annual bonus eligibility
- Benefits package; specific benefit offerings are referenced on the company careers benefits page
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What This Job Offers
Job Type
Full-time
Career Level
Mid Level
