Downstream Manufacturing Training Lead — 24/7 Ops

FUJIFILM Biotechnologies; Holly Springs (NC); On-site; USD 75,000 - 110,000; Full time

Job summary

FUJIFILM Biotechnologies in Holly Springs, NC, is seeking a Manufacturing Support Associate 3, Training (Downstream Manufacturing). This hands-on technical leader drives operational readiness, leads troubleshooting, and champions training and documentation excellence—enabling safe, consistent, on-time production.

You will join a dynamic biomanufacturing site focused on 24/7 operations, collaborating across teams to deliver high-quality products while maintaining compliance and continuous

Qualifications

• High school diploma with 8 years of related experience or
• Associate’s or BS/BA with required direct experience in manufacturing
• Experience in cGMP environments and documentation practices preferred
• Military experience or training equivalent may be accepted

Responsibilities

• Lead operational readiness during project phases, including site commissioning and qualification efforts.
• Serve as a process SME and lead troubleshooting to sustain reliable operations.
• Coordinate batch planning, build process templates, import plans, and manage preventive maintenance schedules.
• Recommend and update manufacturing documentation to keep procedures current, clear, and compliant.
• Initiate or support training programs, onboarding, and curriculum development and management.
• Coordinate non-batch activities and documentation for changeover, PMs, and column packing.
• Support technology transfer activities to enable smooth scale‑up/scale‑down.
• Initiate or support CAPAs and CI initiatives to drive continuous improvement.
• Identify and drive highly technical improvement projects within Downstream Manufacturing.
• Support inspections and audits with accurate documentation and clear communication.
• Collaborate cross‑functionally and define methods on new assignments.
• Perform other duties to meet manufacturing goals in a 24/7 environment; flexible hours may be required.

Skills

Troubleshooting

Batch planning

Documentation management

Training program development

Cross-functional collaboration

Education

BS/BA in life sciences or engineering

Associate’s degree

High school diploma with experience

Equivalent military experience

Job description

FUJIFILM Biotechnologies in Holly Springs, NC, is seeking a Manufacturing Support Associate 3, Training (Downstream Manufacturing). This hands-on technical leader drives operational readiness, leads troubleshooting, and champions training and documentation excellence—enabling safe, consistent, on-time production.

You will join a dynamic biomanufacturing site focused on 24/7 operations, collaborating across teams to deliver high-quality products while maintaining compliance and continuous