Senior Specialist, Operational Excellence

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

Job summary

KBI Biopharma in Durham, North Carolina is seeking an Operational Excellence Specialist to support the implementation of the KBI Business System. This full-time role focuses on shop-floor engagement to drive continuous improvement through Lean methodologies, time studies, and coaching.

The ideal candidate will have a degree in science or engineering and strong skills in Lean practices and problem-solving tools. This position offers competitive compensation in a regulated biomanufacturing environment.

Qualifications

• Minimum 1 year experience in manufacturing or Lean deployment.
• 3+ years experience in GMP or regulated environments for Senior Specialist.
• Ability to motivate and coach others.

Responsibilities

• Support the KBI Business System deployment.
• Facilitate Lean Kaizen events for process efficiency.
• Provide coaching on Practical Problem Solving.

Skills

Lean Six Sigma Green Belt certification

Time-study tools proficiency

GMP cleanroom working knowledge

Lean tools expertise

Education

Bachelor’s degree in science or engineering

Tools

Microsoft Word

Excel

PowerPoint

MiniTab

PowerBI

Job description

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.

Key Responsibilities

• 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.

Qualifications

• 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 for excellence, continuous improvement, simplification, and making things easier.
• Ability to motivate, influence, and coach others under their direct or indirect management.

Language, Reasoning, and Math Abilities

• Read and interpret English documents such as safety rules, operating and maintenance instructions, procedure manuals, batch and production records; write routine reports and correspondence.
• Solve practical problems and handle a variety of variables where limited standardization exists; interpret instructions in written, oral, diagram, or schedule forms; strong time‑management and multitasking skills; produce high‑quality documentation.
• Quickly grasp complex technical concepts and communicate them clearly in text and pictures.
• Perform basic arithmetic operations, compute rates, ratios, percentages, and interpret graphs.

Physical Demands

• Must be able to wear appropriate PPE 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.

Computer and Equipment Skills

• Proficient with Microsoft Word, Excel, and PowerPoint.
• Knowledge of MiniTab, PowerBI, and/or Power Automation is a plus.
• Basic office equipment usage (computer, copier, etc.).

Working Conditions

• Full‑time, on‑site position, typically 8 hours per day, Monday through Friday; flexibility may be required.
• Role may require coverage on alternate shifts, including early morning, evening, or overnight hours, depending on project needs.
• Periodic weekend availability may be required to support Kaizen events, system implementations, or cross‑functional activities.
• 80 % shop‑floor based in GMP manufacturing environments, cleanrooms, and support areas.
• Remaining 20 % may be spent in an office or conference room setting for documentation, planning, data analysis, and reporting.
• Must adhere to all Good Manufacturing Practices (GMP) and Environmental, Health, and Safety (EHS) standards.

EEO and Diversity Statement

KBI Biopharma, Inc. is an EEO/AA employer and actively seeks to diversify its workforce. 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.