Senior Operational Excellence Specialist

Company Overview

FUJIFILM Biotechnologies is building the future of bioproduction in Holly Springs, North Carolina. By end of 2025, we'll open North America's largest end-to-end CDMO biopharmaceutical manufacturing facility, offering drug substance production, fill-finish, and packaging under one roof.

We're looking for passionate, mission-driven people to help us realize this exciting vision and deliver the next vaccine, cure, or therapy. We offer a dynamic work environment and we're proud to cultivate a culture that will fuel your purpose, energy, and drive-what we call Genki. Ready to shape the future of medicine? Let's transform healthcare together!

Holly Springs, North Carolina, combines small-town warmth with proximity to Raleigh's thriving tech scene, making it the perfect blend of community and opportunity.

Fujifilm is globally headquartered in Tokyo with over 70,000 employees across four key business segments of healthcare, electronics, business innovation, and imaging. We are guided and united by our Group Purpose of "giving our world more smiles." Visit:

Overview

The Sr. Operational Excellence (OpEx) Specialist is an experienced, hands-on individual contributor responsible for designing, leading, and sustaining
continuous improvement initiatives that improve safety, quality, delivery, cost, and employee engagement across the site and/or network. Leveraging
deep Lean Six Sigma expertise (Black Belt) and strong change leadership, this role partners with functional leaders in Manufacturing, Quality, Supply Chain, Engineering, and Support functions to identify value creation opportunities, execute improvement projects through the full DMAIC/PDCA lifecycle, build capabilities, and embed standard work and visual management. This role ensures measurable business outcomes aligned with company strategy and compliance requirements (cGMP, EHS), and acts as a coach and catalyst for a culture of operational excellence.

External US

What You'll Do:

• Translates site strategy into an annual OpEx plan, with a prioritized portfolio of projects linked to key performance indicators (safety, quality, delivery, cost, morale).
• Facilitates value stream mapping and diagnostic assessments to identify waste, constraints, and improvement opportunities.
• Builds charters, define problem statements, baselines, targets, scope, and success criteria.
• Leads cross-functional Lean Six Sigma projects from define through control; apply the appropriate toolkit (DMAIC, PDCA, Kaizen, 5S, SMED, visual management, standard work, A3, mistake proofing, SPC).
• Quantifies financial and operational impact (cost savings/avoidance, throughput, cycle time, OEE, right first time) and partner with Finance to validate benefits.
• Establishes control plans and handoffs to ensure sustainability, audit adherence to standard work and control metrics.
• Implements daily management systems, tiered visual performance boards, and leader standard work.
• Facilitates root cause analysis (5 Whys, fishbone, fault tree) and corrective/preventive action closure for chronic issues.
• Develops and maintains dashboards; track and report project performance, benefits realization, and KPI trends to leadership.
• Designs and delivers Lean Six Sigma training (awareness to Green Belt level), coach project teams, and mentor Green Belts.
• Builds problem-solving capability at all levels; model effective facilitation and change leadership behaviors.
• Creates, refines, and deploys OpEx standards (playbooks, templates, standard work, audit criteria).
• Ensures improvement initiatives are aligned with quality system requirements, validation needs, data integrity, and EHS standards.
• Applies structured change management (stakeholder analysis, communications, readiness, adoption metrics) to accelerate outcomes.
• Fosters engagement and recognition for teams; promotes a learning culture through retrospectives, yokoten (best-practice sharing), and communities of practice.
• Partners with leaders across Manufacturing, Quality, Supply Chain, Engineering, IT, HR, and Finance to remove barriers and deliver results.
• Prepares and presents concise updates and business cases to site and functional leadership
• Perform other duties as assigned.

Minimum Requirements:

• Bachelor's degree in science, business, or a related field with 8 years of applicable industry experience such as Operational Excellence,
  Project Management, Continuous Improvement within manufacturing, supply chain, quality, or engineering environments
  OR
• Master's degree Science, Business or a related field 6 years of applicable industry experience such as Operational Excellence,
  Project Management, Continuous Improvement within manufacturing, supply chain, quality, or engineering environments
• Experience and demonstrated track record leading cross-functional Lean Six Sigma projects to completion with sustained results
  Advanced Experience in Lean Six Sigma knowledge; proven application of DMAIC/PDCA, value stream mapping, kaizen events, 5S, SMED, visual management, standard work, SPC, and mistake proofing in regulated operations.
• Experience leading and facilitating group process and collaboration

Preferred Requirements:

• Prior experience working with Pharma or Bio-tech industry
• Experience standing up daily management systems and/or OpEx deployment models at the site or value stream level.
• Strong influencing, collaboration, oral and written communications skills

Physical Requirements:

• Ability to stand for prolonged periods of time (30 minutes)
• Ability to sit for prolonged periods of time (30 minutes)
• Ability to conduct activities using repetitive motions that include wrists, hands and/or fingers

EEO Information

Fujifilm is committed to providing equal opportunities in hiring, promotion and advancement, compensation, benefits, and training regardless of nationality, age, gender, sexual orientation or gender identity, race, ethnicity, religion, political creed, ideology, national, or social origin, disability, veteran status, etc.

ADA Information

If you require reasonable accommodation in completing this application, interviewing, completing any pre-employment testing, or otherwise participating in the employee selection process, please direct your inquiries to our HR Department ([email protected]).