Senior Specialist, Operational Excellence

About this role

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. This 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 this role includes performing time and motion studies , standard work analysis, and supporting the implementation of Lean principles in a regulated biomanufacturing environment.

Job Responsibilities Continuous Improvement Deployment • 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) targeting 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 the impact of improvement initiatives using value capture tools (e.g., cost avoidance, cycle time reduction, productivity KPIs).

Training & Coaching • Deliver Lean training workshops and coach site leaders and teams on the use of Lean tools and behaviors. • Promote and guide implementation of 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.

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 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.

Responsibility : • Shop Floor Gemba & Observation: Daily engagement at the Gemba to observe work as it happens, identify waste, and support teams in continuous improvement. • Time & Motion Studies / Process Analysis: Conduct time studies, takt/cycle time calculations, and work content analysis to identify process variation and bottlenecks. • Daily Management System (Tiered Accountability): Support maturity of SQDCP tiered boards, visual management, and performance escalation from Tier 1 and 2. • Standard Work Development & Implementation: Assist in standard work development and deployment, documentation, operator work instructions, and auditing 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. • Training & Coaching at Gemba: Coach associates, team leads, supervisors, and managers on Lean tools, problem solving, and KBI Business System principles through hands-on support. • Governance Support & Performance Reporting: Support CI Steering Committee, Obeya Room routines, and impact tracking via dashboards and value capture logs.

Minimum Requirements Knowledge, Skills, Abilities • 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 their direct or indirect management

Language Ability •  Ability to read and interpret English documents such as safety rules, operating and maintenance instructions, procedure manuals, batch and production records. Ability to write routine reports and correspondence.

Reasoning Ability •  Ability to solve practical problems and deal with a variety of concrete variables in situations where only limited standardization exists. Ability to interpret a variety of instructions furnished in written, oral, diagram, or schedule form. Strong time management skills and an ability to multitask in a face paced environment. Ability to de

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