Manufacturing Specialist, Continuous Improvement

FUJIFILM Healthcare Americas Corporation; Holly Springs (NC); On-site; USD 90,000 - 120,000; Full time

Job summary

FUJIFILM Biotechnologies in Holly Springs, NC, is seeking a Continuous Improvement and 5S lead to drive operational excellence across our manufacturing network. You will govern CI initiatives, champion 5S education, and deliver hands-on training to production teams to improve safety, quality, and efficiency.

In this role, you’ll coordinate intake, review, monitoring, and reporting of CI programs, partner with cross-functional teams, and ensure compliant, standardized processes while mentoring

Qualifications

• High School Diploma or GED with 10 years related experience or equivalent military experience.
• Associate’s degree with 8 years direct experience in life sciences or engineering.
• Bachelor’s degree with 6 years direct experience in life sciences or engineering.
• Equivalent military experience/training.

Responsibilities

• Support operational readiness initiatives and site commissioning and qualification efforts.
• Act as a process subject matter expert, supporting troubleshooting in your area(s).
• Coordinate batch planning, including process template creation, and manage PM imports and schedules.
• Maintain current and accurate documentation and timely updates of records.
• Coordinate non-batch activities such as changeovers, PMs, and column packing.
• Assist in inventory management and support the use of SAP for manufacturing operations.
• Support technology transfer activities within the manufacturing domain.
• Ensure compliance with safety procedures and cGMP requirements.
• Manage, perform, initiate, or support change management records, investigations, CAPAs, and CI activities.
• Identify and drive improvement projects in drug substance manufacturing to reduce waste, improve flow, and enhance reliability.
• Assist and support inspections and audits to ensure readiness and compliance.

Skills

CI leadership

5S governance

Training coaching

SAP knowledge

Documentation control

Education

High School Diploma/GED

Associate’s degree in life sciences or engineering

Bachelor’s degree in life sciences or engineering

Equivalent military experience/training

Tools

SAP

Job description

Drive operational excellence across our manufacturing network. In this role, you’ll lead our Continuous Improvement (CI) and 5S programs—governing intake, review, monitoring, and reporting of CI initiatives while delivering hands‑on training and coaching to manufacturing teams. You will champion 5S education (sort, straighten, standardize, sustain) across all factories to build a culture of safety, quality, and efficiency.

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

Job Description

What You’ll Do

During Project Phase

• Support operational readiness initiatives as well as site commissioning and qualification efforts.

In Operations

• Act as a process subject matter expert, supporting troubleshooting in your respective area(s).
• Coordinate batch planning, including process template creation, and manage preventive maintenance (PM) imports and schedules.
• Maintain current and accurate documentation, ensuring timely updates of records (including redlines and process improvements).
• Coordinate non-batch activities such as changeovers, PMs, and column packing.
• Assist in inventory management and support the effective use of SAP for manufacturing operations.
• Support technology transfer activities within the manufacturing domain.
• Ensure compliance with safety procedures and cGMP requirements in the manufacturing environment.
• Manage, perform, initiate, or support change management records, investigations, corrective and preventive actions (CAPAs), and continuous improvement (CI) activities.
• Identify and drive improvement projects in drug substance manufacturing to reduce waste, improve flow, and enhance reliability.
• Assist and support inspections and audits, helping to ensure a state of readiness and compliance.

Continuous Improvement And 5S Governance

• Lead intake, prioritization, and reporting of CI initiatives with clear KPIs and benefit tracking.
• Deliver targeted training and education for CI and 5S, coaching Manufacturing Associates on sort and straighten, and standardizing/sustaining best practices across all factories.
• Partner with cross‑functional teams to embed standard work, visual management, and daily tiered accountability.

Minimum Education And Experience Requirements

• High School Diploma/GED and 10 years of related experience OR
• Associate’s degree, preferably in life sciences or engineering, with 8 years of direct experience OR
• Bachelor’s degree, preferably in life sciences or engineering, with 6 years of direct experience OR
• Equivalent military experience/training

Preferred Education And Experience Requirements

• Previous experience leading CI and 5S programs
• Lean certification
• Strong cGMP manufacturing operations experience
• Understanding of operations sequence and cadence of activities
• Prior experience in updating and creating manufacturing documents per schedule
• Previous experience leading CI and 5S programs; Lean certification preferred

What You Bring

• Strong verbal and written communication skills
• Strong time management and prioritization
• Agility in a fast‑paced environment with the ability to pivot and adjust plans
• Critical thinking and superior problem‑solving abilities
• A team‑first mindset and the ability to work effectively in a global, cross‑functional environment, building strong relationships

Ready to build a world‑class manufacturing system—and sustain it?

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]).