Senior Specialist, Operational Excellence

Job Summary

KBI Biopharma seeks a highly motivated Operational Excellence (OpEx) Specialist or Senior Specialist to support the implementation and sustainability of the KBI Business System at its Patriot Park manufacturing site in North Carolina. The role is 80 % shop‑floor engagement, partnering with Operations, Quality, and Support to drive real‑time improvement, reduce variability, and optimize process flow. Key functions include time‑and‑motion studies, standard work analysis, and Lean principle implementation in a regulated biomanufacturing environment.

• Support deployment of 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) focused on process efficiency, quality improvement, waste reduction, and productivity gains.
• Utilize problem‑solving methodologies (A3, 5 Whys, Fishbone, Root Cause Analysis, RCCM, DMAIC) to address and eliminate chronic issues.
• Track and report improvement initiative impact using value‑capture tools such as cost avoidance, cycle‑time reduction, and productivity KPIs.
• Deliver Lean training workshops and coach site leaders and teams on Lean tools and behaviors.
• Promote and guide a zero‑loss mindset and employee engagement in continuous improvement initiatives.
• 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 and problem solving.
• Collaborate with functional teams to create and execute action plans based on Gemba findings and study data.
• 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.
• Act as an internal consultant supporting cross‑functional projects aligned to 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 and observation: daily engagement to observe work, identify waste, and support teams.
• Perform time‑and‑motion studies and process analysis to identify variation and bottlenecks.
• Support maturity of SQDCP tiered boards, visual management, and performance escalation from Tier 1 and 2.
• Assist in standard work development, deployment, documentation, operator instructions, and auditing for consistency and compliance.
• Lead or support CI projects using PDCA or DMAIC targeting efficiency, quality, and cost improvements.
• Coach associates, team leads, supervisors, and managers on Lean tools and KBI Business System principles through hands‑on support.
• 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 experience supporting manufacturing, continuous improvement, or Lean deployment.
• Senior Specialist: 3 + years 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…