Operational Excellence Engineer II (Onsite)

Tolmar Careers•Windsor, CO

1d•Onsite

About The Position

The Operational Excellence Engineer II is a member of the Operational Excellence core team and helps drive productivity, compliance, and cost effectiveness across pharmaceutical Manufacturing and Quality Operations while advancing a culture of continuous improvement and customer value. The role analyzes manufacturing and related Quality Assurance processes in a GMP-regulated environment, with emphasis on aseptic and sterile manufacturing, identifies improvement opportunities, and implements Lean and Six Sigma projects to simplify processes, improve quality, reduce deviations and waste, increase throughput, and support reliable pharmaceutical product supply. The engineer leads and supports cross-functional process improvement initiatives, develops performance metrics and reports, facilitates structured problem solving and Kaizen events, and provides Lean and technical training. The role also assists with GMP documentation and evaluates the business value and return on investment of process and equipment improvements. Work is onsite in Windsor, Colorado, during core hours of Monday through Friday, 8:00 a.m. to 5:00 p.m. The work may include controlled cleanroom areas requiring gowning and compliance with 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 performance improvement in a GMP-regulated pharmaceutical manufacturing environment.
Project management and planning skills, including the ability to independently manage project timelines, resources, and milestones.
Ability to work independently with limited supervision and effectively in a team-based culture 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 a regulated manufacturing setting.
Ability to use process improvement tools to reduce deviations, improve right-first-time performance, strengthen process capability, and support cleanroom discipline and contamination-control practices.
Working knowledge of pharmaceutical manufacturing performance metrics, including OEE, yield, batch cycle time, right-first-time, schedule attainment, and deviation trends; familiarity with FDA, cGMP, and data integrity expectations.
Proficiency with Visio, Microsoft Word, Excel, and PowerPoint.
Detail orientation and ability to analyze information, create metrics, and explain their relationship 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 and interested in leading teams and projects.

Nice To Haves

Experience supporting aseptic or sterile manufacturing operations; such experience is strongly preferred.
Lean/Six Sigma Green Belt or Black Belt certification.
Experience in low-volume, high-changeover manufacturing in pharmaceutical, biologics, medical device, or another GMP-regulated environment.
Some experience with 2D/3D CAD and statistical analysis software such as AutoCAD, SolidWorks, Minitab, or JMP.
Familiarity with aseptic processing principles, contamination control strategy, cleanroom practices, and sterile manufacturing controls.

Responsibilities

Identify and execute opportunities for cost savings, increased throughput, improved schedule adherence, and workflow optimization in pharmaceutical manufacturing, including aseptic and sterile processing, while maintaining compliance, product quality, contamination control, and patient safety.
Conduct workflow analyses, time studies, and data collection; improve and standardize GMP-regulated processes using Lean and Six Sigma tools, including value stream mapping, process mapping, 5S, cycle time analysis, waste/value assessments, TPM, capacity analysis, and OEE.
Deploy best practices across manufacturing, maintenance, warehouse, quality, and material management, focusing on batch cycle time, right-first-time performance, deviation reduction, and operational performance.
Develop KPIs, scorecards, and dashboards to support resource utilization, batch release readiness, deviation trending, CAPA effectiveness, yield, scrap reduction, process efficiency, and aseptic/sterile manufacturing indicators.
Prepare and present productivity and performance reports, dashboards, and presentations for leadership and stakeholders.
Facilitate cross-functional problem-solving workshops for root cause investigations, recurring deviation reduction, CAPA implementation, and process robustness in partnership with Manufacturing, Quality, Engineering, Validation, and Supply Chain.
Organize and facilitate Kaizen events focused on People, Safety, Quality, Delivery, and Costs.
Design or redesign work areas and layouts to improve ergonomics and reduce repetitive motions and inefficient methods.
Role model and drive application of the DMAIC process improvement approach through Diagnostic, Design, Plan, and Implement phases.
Conduct business-level diagnostics, including assessment of business value, impact, and return on investment for process and equipment improvements.
Lead, mentor, and execute multiple improvement projects and initiatives informed by diagnostic data.
Conduct Lean and technical training to 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.