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 deliver high quality documentation paying attention to detail.
• Ability to quickly grasp complex technical concepts and make them easily understandable in text and pictures.

Math Ability

• Ability to add, subtracts, multiply, and divides in all units of measure, using whole numbers, common fractions, and decimals. Ability to compute rate, ratio, and percent and to draw and interpret various graphs

Physical Demands

• The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this role:
• GMP Environment Requirements: Must be able to wear appropriate PPE (e.g., gowns, gloves, hair/beard covers, safety glasses, shoe covers) and follow gowning procedures to enter controlled cleanroom areas and classified environments.
• Environment: May be exposed to variable temperatures, mechanical equipment, and pharmaceutical-grade cleaning agents used in GMP spaces.

Computer Skills

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

Equipment Use

• Basic office equipment (computer, copy machine, etc.)

Working Conditions

Work Hours: This is a full-time, on-site position, typically requiring 8 hours per day, Monday through Friday. Standard hours are aligned with site operations, but flexibility may be required.

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.

Work Environment:

• The role is 80% shop floor-based, primarily within GMP manufacturing environments, cleanrooms, and support areas.
• Must adhere to all Good Manufacturing Practices (GMP) and Environmental, Health, and Safety (EHS) standards.
• The remaining 20% of time may be spent in an office or conference room setting for documentation, planning, data analysis, and reporting.
• Workspace: A designated workstation will be provided for office work, but a significant portion of the work is mobile, hands-on, and collaborative in nature.