Operational Excellence Engineer II; Onsite

Position: Operational Excellence Engineer II (Onsite)
Core

Hours:

Monday - Friday, 8:00am-5:00pm

Position is onsite in Windsor, CO

Purpose and Scope

The Operational Excellence Engineer II is a member of the Operational Excellence core team and plays a key role in driving productivity, compliance, and cost effectiveness across pharmaceutical Manufacturing and Quality Operations while helping to further establish a culture of continuous improvement and customer value. Specifically, the OpEx Engineer is responsible for analyzing manufacturing and related Quality Assurance processes in a GMP-regulated environment, with added emphasis on aseptic and sterile manufacturing operations, identifying improvement opportunities, and implementing projects using Lean and Six Sigma methodologies to simplify processes, improve quality, reduce deviations, remove waste, increase throughput, and support reliable supply of pharmaceutical products.

Essential Duties & Responsibilities

• Identify and execute opportunities for cost savings, increased throughput, improved schedule adherence, and workflow optimization across pharmaceutical manufacturing operations, including aseptic and sterile processing environments, while maintaining compliance, product quality, contamination control, and patient safety.
• Conduct in-depth workflow analyses, time studies, and data collection to improve and standardize GMP-regulated manufacturing processes through application of Lean and Six Sigma methodologies including value stream mapping, process mapping, 5S, cycle time analysis, waste/value assessments, TPM, equipment and resource capacity analysis, and OEE. Deploy best practices across manufacturing, maintenance, warehouse, quality, and material management with focus on batch cycle time, right-first-time, deviation reduction, and performance improvement within cleanroom, aseptic, and sterile processing operations.
• Provide process and technical expertise through analyses and development of KPIs, scorecards, and dashboards that support improved resource utilization, batch release readiness, deviation trending, CAPA effectiveness, yield, scrap reduction, overall process efficiency, and key aseptic/sterile manufacturing indicators such as environmental monitoring trends, intervention reduction, and line clearance effectiveness.
• Develop and present detailed productivity and performance reports, dashboards and presentations for leadership and key stakeholders.
• Facilitate and lead cross-functional problem-solving workshops using structured methodologies and tools to support root cause investigations, reduce recurring deviations, strengthen CAPA implementation, and improve process robustness in partnership with Manufacturing, Quality, Engineering, Validation, and Supply Chain, with particular focus on aseptic process reliability, contamination control, and sterile operations.
• Organize and facilitate Kaizen events focused on improving People, Safety, Quality, Delivery, and Costs
• Design, redesign, and enhance work areas and layouts to be more ergonomically favorable, reduce repetitive motions and inefficient methods.
• Role model and drive the application of DMAIC process improvement within the phases of Diagnostic, Design, Plan and Implement throughout operations.
• Conduct business-level diagnostic including business value, impact and return on investment (ROI) for process and equipment improvements. Lead, mentor and execute multiple improvement projects and initiatives that flow from diagnostic data
• Conduct Lean and technical training to increase engagement, build capabilities and embed lean skill set across operations to increase productivity and efficiencies.
• Assist in the creation and revision of GMP documentation including work instructions, standard operating procedures, aseptic technique and cleanroom behavior documentation, batch record improvements, protocols, specifications, reports, and other controlled and non-controlled documents to support compliant, efficient operations.
• Perform other related duties as assigned.

Knowledge, Skills & Abilities

• Understanding and experience working in a Lean culture supporting continuous performance improvement within a GMP-regulated pharmaceutical manufacturing environment, preferably including aseptic or sterile processing operations.
• Project management & planning skills with demonstrated ability to Independently manage project timelines, resources, and milestones for process improvement initiatives.
• Demonstrated ability to work independently with limited supervision.
• Ability to work in a team-based culture and interact successfully with employees at all organizational levels.
• Excellent interpersonal communication, problem-solving and organizational skills with demonstrated ability to engage others outside of direct management.
• Deep 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…