Senior Specialist, Operational Excellence

KBI Biopharma, Inc.; Durham (NC); On-site; USD 70,000 - 90,000; Full time

Job summary

KBI Biopharma, Inc. is seeking an experienced Operational Excellence Specialist in Durham, NC to support the implementation of the KBI Business System. The expert will engage 80% of the time on the shop floor, enhancing operational performance through initiatives like Lean principles and continuous improvement projects.

This full-time, on-site position requires a Bachelor's in a science or engineering field, with experience in a GMP environment. Key responsibilities include leading Kaizen events, training, and developing performance management systems.

Qualifications

• 1-3+ years of experience in a GMP or regulated manufacturing environment.
• Ability to analyze shop floor data and drive decisions.
• Proficient with time study tools and techniques.

Responsibilities

• Deploy KBI Business System and facilitate Kaizen events.
• Deliver Lean training workshops and provide coaching.
• Support the development of performance management systems.

Skills

Lean Six Sigma Green Belt

Time study techniques

Lean tools like 5S, SMED

Problem-solving methodologies

Education

Bachelor's degree in science or engineering

Tools

Microsoft Excel

PowerBI

Job description

Job Summary

KBI Biopharma is seeking a highly motivated and experienced Operational Excellence (OpEx) Specialist or Senior Specialist to support the implementation and sustainability of the KBI Business System at our Patriot Park manufacturing site in North Carolina. This individual will be instrumental in driving continuous improvement initiatives that align with site and global strategy, enhance operational performance, and foster a culture of excellence across functions. The role will be 80% dedicated to shop floor engagement, partnering closely with Operations, Quality, and Support functions to drive real‑time improvement, reduce variability, and optimize process flow through direct observation, facilitation, and collaboration. A critical component of the role includes performing time and motion studies, standard work analysis, and supporting the implementation of Lean principles within a regulated biomanufacturing environment.

Job Responsibilities

• Continuous Improvement Deployment Support: Deploy the KBI Business System (Lean Management System) including Daily Management, Visual Controls, Standard Work, Gemba, and Leader Standard Work; facilitate and lead Kaizen events (PDCA/DMAIC) targeting process efficiency, quality improvement, waste reduction, and productivity gains; utilize problem‑solving methodologies (A3, 5 Whys, Fishbone, Root Cause Analysis, RCCM, DMAIC) to eliminate chronic issues; track and report the impact of initiatives through value‑capture tools.
• Training & Coaching: Deliver Lean training workshops and coach site leaders and teams on Lean tools and behaviors; promote a zero‑loss mindset and employee engagement; provide coaching on Practical Problem Solving, Tiered Accountability, and Layered Process Audits; champion a Zero‑Loss Culture by empowering shop floor teams to drive daily Kaizen.
• Performance Management & Governance: Support the development and maturity of site performance management systems (SQDCP boards, tier meetings, KPI dashboards); assist departments in developing metrics and visual management systems aligned to business goals; participate in governance routines such as Obeya steering committee meetings, Transformation Office updates, and CI Steering Committee.
• Strategic Project Support: Act as an internal consultant for cross‑functional projects aligned with strategic goals (Hoshin Kanri); conduct process mapping, time studies, and waste analysis to recommend and implement improvements; collaborate with Digital Enablement teams on systems, automation, and data‑driven decision‑making.
• Shop Floor Gemba & Observation: Daily engagement at the Gemba to observe work as it happens, identify waste, and support teams in continuous improvement; conduct time and motion studies, takt/cycle time calculations, and work content analysis to identify process variation and bottlenecks; support the maturity of SQDCP tiered boards and visual management.
• Standard Work Development & Implementation: Assist in standard work development and deployment; develop operator work instructions and audit for consistency and compliance.
• Kaizen Facilitation & Problem‑Solving Events: Lead or support CI projects using PDCA or DMAIC methodology targeting efficiency, quality, and cost improvements.
• Governance Support & Performance Reporting: Support CI Steering Committee, Obeya Room routines, and impact tracking via dashboards and value capture logs.

Minimum Requirements

• Bachelor’s degree in a science or engineering field or equivalent combination of education and experience.
• Lean Six Sigma Green Belt certification preferred.
• Specialist: Minimum 1 year of experience supporting manufacturing, continuous improvement, or Lean deployment.
• Senior Specialist: 3+ years of experience in a GMP or regulated manufacturing environment with demonstrated project facilitation and coaching capabilities.
• Strong proficiency in time study tools and techniques (stopwatch, video analysis, standard work combination sheets).
• Familiarity with manufacturing operations in a biopharma, pharmaceutical, or high‑mix, low‑volume environment.
• Ability to analyze shop floor data and drive decisions based on cycle time, changeover duration, yield, and flow.
• Working knowledge of Lean tools: 5S, SMED, VSM, Visual Management, Standard Work, Error Proofing, A3, RCA, DMAIC.
• Comfortable working in GMP cleanroom environments with appropriate PPE.
• Strong business and financial acumen with ability to identify and quantify financial benefit from project work.
• A drive for excellence, continuous improvement, simplification, and making things easier.
• Ability to motivate, influence, and coach others under direct or indirect management.
• English language proficiency for reading, interpreting, writing, and reasoning.
• Strong time‑management skills and ability to multitask in a fast‑paced environment.
• Attention to detail in documentation and ability to convey complex technical concepts clearly.
• Basic mathematics skills (addition, subtraction, multiplication, division, rates, ratios, percentages, graphs).

Physical and Environmental Requirements

Must be able to wear appropriate PPE (gowns, gloves, hair/beard covers, safety glasses, shoe covers) and follow gowning procedures to enter controlled cleanroom areas and classified environments. May be exposed to variable temperatures, mechanical equipment, and pharmaceutical‑grade cleaning agents used in GMP spaces. Physical demands include repetitive lifting, standing, and walking, and the ability to work in a GMP environment with careful adherence to Good Manufacturing Practices (GMP) and Environmental, Health, and Safety (EHS) standards.

Computer Skills

Proficient with Microsoft programs such as Word, Excel, and PowerPoint. Proficient knowledge of MiniTab, PowerBI, and/or Power Automation is a plus.

Working Conditions

Work Hours: Full‑time, on‑site position, typically 8 hours per day, Monday through Friday, with flexibility and occasional shift support.

Shift Support: The role may occasionally require coverage or support on alternate shifts, including early morning, evening, or overnight hours, depending on the needs of improvement initiatives or project timelines.

Weekend Work: Periodic weekend availability may be required to support Kaizen events, system implementations, or cross‑functional activities.

A significant portion of work (80%) is shop‑floor based within GMP manufacturing environments, cleanrooms, and support areas; the remaining 20% may be spent in an office or conference room setting for documentation, planning, data analysis, and reporting.

EEO Statement

KBI Biopharma, Inc. is an EEO/AA employer and actively seeks to diversify its workforce. Therefore, all qualified applicants, regardless of race, color, national origin, religion, gender, gender identity, sexual orientation, age, disability or veteran status, are strongly encouraged to apply.