CI & 5S Leader: Manufacturing Excellence

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

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