Senior Specialist, Operational Excellence

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.

• 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.

• 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…