Continuous Improvement & 5S Lead – Biotech Manufacturing

FUJIFILM Biotechnologies; Holly Springs (NC); On-site; USD 90,000 - 130,000; Full time

Job summary

FUJIFILM Biotechnologies in Holly Springs, NC, seeks a Continuous Improvement/5S Leader to drive operational excellence across its manufacturing network. You will guide CI initiatives, deliver hands-on coaching, and champion 5S education across all factories to build a culture focused on safety, quality, and efficiency.

The role requires leading CI and 5S programs, coordinating batch planning, and ensuring accurate documentation and change management.

Qualifications

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

Responsibilities

• 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.
• Coordinate batch planning, including process template creation, and manage 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.

Skills

Communication skills

Time management

Adaptability

Critical thinking

Team collaboration

Education

Bachelor’s degree in life sciences or engineering

Associate’s degree in life sciences or engineering

High School Diploma/GED

Equivalent military experience/training

Tools

SAP

Job description

FUJIFILM Biotechnologies in Holly Springs, NC, seeks a Continuous Improvement/5S Leader to drive operational excellence across its manufacturing network. You will guide CI initiatives, deliver hands-on coaching, and champion 5S education across all factories to build a culture focused on safety, quality, and efficiency.

The role requires leading CI and 5S programs, coordinating batch planning, and ensuring accurate documentation and change management.