KBI
Senior Specialist, Operational Excellence
USA - NC - Durham - National Way · Senior · Full-time
Sponsorship not specifiedDetected 22 days ago
Data AnalysisExcelAuditingProcess ImprovementPerformance ManagementGMPProblem SolvingTime ManagementMentoringMicrosoft OfficeLean Manufacturing
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
- Daily engagement at the Gemba to observe work as it happens, identify waste, and support teams in continuous improvement.
- Support maturity of SQDCP tiered boards, visual management, and performance escalation from Tier 1 and 2.
- Lead or support CI projects using PDCA or DMAIC methodology targeting efficiency, quality, and cost improvements.
- 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.
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.
- Standard hours are aligned with site operations, but flexibility may be required.
- Weekend Work: Periodic weekend availability may be required to support Kaizen events, system implementations, or cross-functional activities.
- Knowledge, Skills, Abilities
Nice to have
- Lean Six Sigma Green Belt certification preferred.
- Must be proficient with Microsoft programs such as Word, Excel, and PowerPoint
- Proficient knowledge of MiniTab, PowerBI, and/or Power Automation is a plus
- Basic office equipment (computer, copy machine, etc.)
Skills
- 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
- Ability to motivate, influence, and coach others under their direct or indirect management
- Ability to quickly grasp complex technical concepts and make them easily understandable in text and pictures.
- Utilize problem-solving methodologies (A3, 5 Whys, Fishbone, Root Cause Analysis, RCCM, DMAIC) to address and eliminate chronic issues.
Benefits
- Must adhere to all Good Manufacturing Practices (GMP) and Environmental, Health, and Safety (EHS) standards.
- 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.
- 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.
This listing is sourced directly from KBI's careers page and normalized into a canonical job model.