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