KBI Biopharma

KBI Biopharma

Senior Specialist, Operational Excellence

USA - NC - Durham - National Way · Senior · Full-time

Sponsorship not specifiedDetected 102 days ago
Data AnalysisExcelAuditingProcess ImprovementPerformance ManagementGMPProblem SolvingTime ManagementMentoringMicrosoft OfficeLean Manufacturing

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Sponsors this role80
Entry-level history0
PERM / green-card track0
Lottery odds40
Fits your clock70

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About the role

  • 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.
  • 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.

Responsibilities

  • Support deployment of the KBI Business System (Lean Management System) including Daily Management, Visual Controls, Standard Work, Gemba, and Leader Standard Work.
  • 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).
  • Strategic Project Support
  • 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 & Observation: Daily engagement at the Gemba to observe work as it happens, identify waste, and support teams in continuous improvement.
  • Daily Management System (Tiered Accountability): Support maturity of SQDCP tiered boards, visual management, and performance escalation from Tier 1 and 2.
  • The role is 80% shop floor-based, primarily within GMP manufacturing environments, cleanrooms, and support areas.

Requirements

  • Must be proficient with Microsoft programs such as Word, Excel, and PowerPoint
  • 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.
  • Standard hours are aligned with site operations, but flexibility may be required.

Nice to have

  • 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).
  • 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.
  • 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).
  • Lean Six Sigma Green Belt certification preferred.
  • Strong proficiency in time study tools and techniques (stopwatch, video analysis, standard work combination sheets).

Benefits

  • Must adhere to all Good Manufacturing Practices (GMP) and Environmental, Health, and Safety (EHS) standards.
  • 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.

Company info

  • 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.

Equal opportunity

  • KBI Biopharma, Inc. is an EEO/AA employer and actively seeks to diversify its work force.
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This listing is sourced directly from KBI Biopharma's careers page and normalized into a canonical job model.