Senior Operational Excellence Specialist

FUJIFILM Biotechnologies; Morrisville (NC); On-site; USD 110,000 - 160,000; Full time

Job summary

FUJIFILM Biotechnologies is seeking an experienced Sr. OpEx Specialist to design, lead, and sustain continuous improvement initiatives across the Holly Springs site.

The role requires Lean Six Sigma Black Belt expertise, change leadership, and collaboration with Manufacturing, Quality, Supply Chain, Engineering, IT, HR, and Finance to deliver measurable business outcomes. You will build capabilities, embed standard work, create dashboards, and coach teams while ensuring adherence to cGMP, EHS,

Qualifications

• Bachelor’s or Master’s degree in science, business, or related field with 6–8 years of relevant experience in operational excellence or continuous improvement.
• Experience leading cross-functional Lean Six Sigma projects to completion with DMAIC/PDCA, value stream mapping, kaizen events, 5S, SMED, visual management, standard work, SPC, and mistake proofing in regulated operations.

Responsibilities

• Translate site strategy into an annual OpEx plan with a prioritized project portfolio.
• Facilitate value stream mapping and diagnostic assessments to identify waste and opportunities.
• Lead cross-functional Lean Six Sigma projects from define to control and quantify benefits.
• Develop dashboards and track KPI trends to leadership.
• Coach Green Belts and build problem-solving capability across levels.
• Ensure alignment with quality, validation, data integrity, and EHS standards.

Skills

Lean Six Sigma

DMAIC/PDCA

Cross-functional leadership

Project management

Change management

Data analysis

Education

Bachelor’s degree in science or business

Master’s degree in Science or Business

Job description

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: https://www.fujifilm.com/us/en/about/region/careers

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.

What You'll Do

• Translate site strategy into an annual OpEx plan, with a prioritized portfolio of projects linked to key performance indicators (safety, quality, delivery, cost, morale).
• Facilitate value stream mapping and diagnostic assessments to identify waste, constraints, and improvement opportunities.
• Build charters, define problem statements, baselines, targets, scope, and success criteria.
• Lead 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).
• Quantify financial and operational impact (cost savings/avoidance, throughput, cycle time, OEE, right‑first‑time) and partner with Finance to validate benefits.
• Establish control plans and handoffs to ensure sustainability, audit adherence to standard work and control metrics.
• Implement daily management systems, tiered visual performance boards, and leader standard work.
• Facilitate root cause analysis (5 Whys, fishbone, fault tree) and corrective/preventive action closure for chronic issues.
• Develop and maintain dashboards; track and report project performance, benefits realization, and KPI trends to leadership.
• Design and deliver Lean Six Sigma training (awareness to Green Belt level), coach project teams, and mentor Green Belts.
• Build problem‑solving capability at all levels; model effective facilitation and change leadership behaviors.
• Create, refine, and deploy OpEx standards (playbooks, templates, standard work, audit criteria).
• Ensure improvement initiatives are aligned with quality system requirements, validation needs, data integrity, and EHS standards.
• Apply structured change management (stakeholder analysis, communications, readiness, adoption metrics) to accelerate outcomes.
• Foster engagement and recognition for teams; promote a learning culture through retrospectives, yokoten (best‑practice sharing), and communities of practice.
• Partner with leaders across Manufacturing, Quality, Supply Chain, Engineering, IT, HR, and Finance to remove barriers and deliver results.
• Prepare and present 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 in Science, Business or a related field with 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 ([e-mail]).