Core Hours: Monday - Friday, 8:00am-5:00pmPosition is onsite in Windsor, COPurpose and ScopeThe 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 manufacturing setting; experience using these tools to reduce deviations, improve right-first-time performance, strengthen process capability, and support cleanroom discipline and contamination-control practices.
- Familiarity with aseptic processing principles, contamination control strategy, cleanroom practices, and sterile manufacturing controls.
- Experience with low-volume, high-changeover manufacturing in pharmaceutical, biologics, medical device, or other GMP-regulated environments is preferred; direct experience supporting aseptic or sterile manufacturing operations.
- Working knowledge of pharmaceutical manufacturing performance metrics such as OEE, yield, batch cycle time, right-first-time, schedule attainment, and deviation trends; familiarity with FDA, cGMP, and data integrity expectations.
- Proficient with Visio, MS Word, Excel, PowerPoint; and some experience with 2/3D CAD and statistical analysis software tools e.g., AutoCAD, SolidWorks, Minitab, JMP etc.
- Detail oriented with ability to analyze information, create metrics and articulate the link to business needs/objectives.
- Ability to motivate, influence and lead others with and/or without direct supervisory authority.
- Demonstrated capabilities in achieving process improvements and positive change; ambitious, self-directed and interested in leading teams and projects.
Education & Experience (Required)- B.S. in Engineering, Operations Management, Industrial/ Manufacturing Engineering or a related field required.
- 3 or more years of experience leading process improvement and operational excellence initiatives in pharmaceutical manufacturing or another GMP-regulated manufacturing environment; experience in aseptic or sterile manufacturing operations is strongly preferred.
- Strong understanding and application of Lean and Six Sigma methodologies. Lean/Six Sigma Green Belt or Black Belt certifications strongly preferred.
Working ConditionsWorking conditions are typical for a pharmaceutical manufacturing environment and may include work in controlled cleanroom areas that require adherence to gowning, aseptic behavior, and sterile manufacturing practices.
Compensation and Benefits- Annual pay range $90,000 - $100,000 depending on experience
- Bonus Eligible
- Benefits information: https://www.tolmar.com/careers/employee-benefits
Tolmar compensation programs are focused on equitable, fair pay practices including market-based base pay and a strong benefits package. The final compensation offered may vary from the posted range based on the selected candidates qualifications and experience.
