Manufacturing Support Associate 3, Training

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

Position Overview

Help power reliable, compliant, 24/7 biomanufacturing. As a Manufacturing Support Associate 3, Training (Downstream Manufacturing), you'll be a hands-on technical leader who drives operational readiness, leads troubleshooting, and champions training and documentation excellence-so teams can produce safely, consistently, and on time.

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

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.

Fujifilm is globally headquartered in Tokyo with over 70,000 employees across four key business segments of healthcare, electronics, business innovation, and imaging. We are guided and united by our Group Purpose of "giving our world more smiles." Visit: https://www.fujifilm.com/us/en/about/region/careers

Job Description

About Us

• We are a dynamic, around-the-clock biomanufacturing site focused on delivering high-quality products with safety and compliance at the core.
• You'll join a collaborative team that values continuous improvement, knowledge-sharing, and practical problem-solving.
• We welcome people from all backgrounds and experiences and provide equitable opportunities for growth and impact.

Responsibilities

• Lead operational readiness during project phases, including site commissioning and qualification efforts.
• Serve as a process subject matter expert (SME) for your area(s); lead troubleshooting to restore and sustain reliable operations.
• Coordinate batch planning, including building process templates, importing plans, and managing preventive maintenance (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, corrective and preventive actions (CAPAs), and continuous improvement (CI) initiatives.
• Identify and/or drive highly technical improvement projects within Downstream Manufacturing (DSM) to enhance safety, quality, and efficiency.
• Support internal and external inspections and audits with accurate documentation and clear communication.
• Collaborate cross-functionally; act independently to define methods and procedures on new assignments.
• Perform other duties as assigned to meet manufacturing goals in a 24/7 environment; flexibility with working hours may be required.

Minimum Qualifications (must-have)

• High school diploma with 8 years of related experience OR
• Associate's degree with 6 years of direct experience OR
• BS/BA with 4 years of direct experience
• Equivalent military experience or training

Preferred Qualifications

• Associate's or Bachelor's degree, preferably in life sciences or engineering
• BioWorks or BTEC Capstone cGMP coursework
• Expertise in manufacturing operations with a high degree of troubleshooting ability
• Strong technical experience with batch planning and creation of manufacturing documentation
• Experience with audits, leading investigation support, and leading continuous improvement projects

Benefits

• Competitive compensation with potential shift flexibility to support a 24/7 operation
• Comprehensive health and wellness coverage (medical, dental, vision) and employee assistance resources
• Retirement savings plan with company support
• Generous paid time off, paid holidays, and leave programs
• Learning and development opportunities, including training, certifications, and cross-functional exposure
• Safety-first culture with robust PPE programs and resources
• Inclusive workplace with equal opportunity practices and reasonable accommodations for qualified individuals

If you're energized by building training programs, solving complex problems, and making a measurable impact on compliant production, we'd love to hear from you.

EEO Information

Fujifilm is 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 ([e-mail]).