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.

Job Responsibilities

• 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 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.
• Celebrate and empower 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).
• Aid 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.

Minimum Requirements

• Bachelor’s degree in a science or engineering field or equivalent combination of education and experience.
• Limited 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.
• 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.

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 fast-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, subtract, multiply, and divide 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.

Workplace

• 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.

EEO/AA Employer

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

Application Information

I understand that neither the completion of this application nor any other part of my consideration for employment establishes any obligation for KBI Biopharma, Inc. to hire me. If I am hired, I understand that either KBI Biopharma, Inc. or I can terminate my employment at any time and for any reason, with or without cause and without prior notice. I understand that no representative of KBI Biopharma, Inc. has the authority to make any assurance to the contrary. I attest with my signature below that I have given to KBI Biopharma, Inc. true and complete information on this application. No requested information has been concealed. I authorize KBI Biopharma, Inc. to contact references provided for employment reference checks. If any information I have provided is untrue, or if I have concealed material information, I understand that this will constitute cause for the denial of employment or immediate dismissal.