Manufacturing Specialist, Continuous Improvement

Job Description

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
  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

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.

Location

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.

About the Role

Ready to shape the future of medicine? Let’s transform healthcare together!

Benefits

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.

Pay

Commensurate with experience

Schedule

N/A

Skills

Not specified

Equal Opportunity Employer

We are 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 (FDBN_PNC@fujifilm.com).