Downstream Manufacturing Ops Lead & Training Specialist (24/7)

Merck & Co.; Holly Springs (NC); On-site; USD 90,000 - 120,000; Full time

Benefits offered by this job

Competitive compensation

Health & wellness benefits

401(k) retirement plan

Paid time off

Training and development opportunities

Job summary

Fujifilm Biotechnologies in Holly Springs, NC seeks a Manufacturing Support Associate 3, Training in Downstream Manufacturing. This role leads operational readiness, guides troubleshooting, and champions training and documentation to ensure compliant, 24/7 production.

You will serve as SME for downstream processes, coordinate batch plans, and help sustain safe, efficient operations while driving continuous improvement and quality experiences across teams.

Qualifications

• Minimum 8 years of related experience with a high school diploma.
• 6 years of experience with an Associate's degree.
• 4 years of direct experience with a BS/BA.
• Equivalent military experience or training.

Responsibilities

• Lead operational readiness during project phases, including site commissioning and qualification.
• Serve as SME for Downstream Manufacturing; lead troubleshooting to restore and sustain reliable operations.
• Coordinate batch planning, including building process templates, importing plans, and managing PM schedules.
• Recommend and perform updates to manufacturing documentation to keep procedures current, clear, and compliant.
• Initiate and/or support training programs, onboarding, and curriculum development and management to build team capability.
• Coordinate non-batch activities and documentation for changeover, PMs, and column packing.
• Support technology transfer activities to enable smooth scale-up/scale-down and process adoption.
• Initiate or support change management records, investigations, CAPAs, and CI initiatives.
• Identify and drive highly technical improvement projects within Downstream Manufacturing to enhance safety, quality, and efficiency.
• Support internal and external inspections and audits with accurate documentation and clear communication.

Skills

Troubleshooting

Batch planning

Documentation

Training programs

Education

BS/BA in sciences/engineering

Associate's degree in related field

High school diploma with 8 years experience

Equivalent military experience

Job description

Fujifilm Biotechnologies in Holly Springs, NC seeks a Manufacturing Support Associate 3, Training in Downstream Manufacturing. This role leads operational readiness, guides troubleshooting, and champions training and documentation to ensure compliant, 24/7 production.

You will serve as SME for downstream processes, coordinate batch plans, and help sustain safe, efficient operations while driving continuous improvement and quality experiences across teams.