Manufacturing Support Associate 3

FUJIFILM Biotechnologies; Holly Springs (NC); On-site; USD 120,000 - 180,000; Full time

Benefits offered by this job

Competitive pay

Health benefits

Retirement plan

PTO & holidays

Training & development

Safety culture

Job summary

FUJIFILM Biotechnologies is seeking an experienced manufacturing specialist in Holly Springs, NC, to ensure safe, compliant, and reliable 24/7 production. The role sits within DSM as part of the Manufacturing family and involves independent work, cross-functional collaboration, and technical leadership.

The candidate will lead site readiness, troubleshooting, batch planning, and documentation updates, while supporting tech transfers and continuous improvement initiatives to elevate operational

Qualifications

• High school diploma with 8 years related experience.
• Experience with audits, investigations support, and CI projects.
• Strong troubleshooting and manufacturing documentation skills.

Responsibilities

• Lead operational readiness during project phases and drive site commissioning and qualification.
• Coordinate batch planning, process template creation/import and PM plan management.
• Lead troubleshooting as SME for assigned area and update manufacturing documentation.
• Support tech transfers to ensure seamless integration and execution.
• Initiate change management records, CAPAs, and CI activities.
• Identify and drive highly technical improvement projects within DSM to enhance performance.

Skills

Manufacturing operations

Troubleshooting

Batch planning

Documentation

Continuous improvement

Education

BS/BA in life sciences or engineering

Associate’s Degree in life sciences or engineering

High school diploma + 8 years experience

Job description

Join a high-impact manufacturing team where your expertise ensures safe, compliant, and reliable production around the clock. If you thrive on problem-solving, orchestrating smooth operations, and driving continuous improvement, this role offers the opportunity to lead, influence, and make a measurable difference every day.

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

About Us

Job Description

• We are a 24/7 manufacturing operation committed to delivering reliable, compliant, and high-quality production.
• This role sits within DSM as part of the Manufacturing family.
• You’ll be a highly skilled specialist who contributes to the development of concepts and techniques, often acting independently and serving as a facilitator or team leader.
• You’ll report to a Manager and work cross-functionally with operations, quality, maintenance, and technical transfer teams.

What You’ll Do

• Lead operational readiness during project phases:
  • Drive site commissioning and qualification efforts.
  • Prepare systems, processes, and teams for successful start-up and steady-state operations.
• Ensure reliable production during routine operations:
  • Lead troubleshooting as a process subject matter expert (SME) for assigned area(s).
  • Coordinate batch planning, including process template creation/import and preventive maintenance (PM) plan management.
  • Recommend and perform updates to manufacturing documentation.
  • Coordinate non-batch activities and create documentation for changeovers, PMs, and column packing.
• Support technology transfers to ensure seamless integration and execution.
• Initiate or support change management records, investigations, corrective and preventive actions (CAPAs), and continuous improvement (CI) activities.
• Identify and/or drive highly technical improvement projects within DSM to enhance performance, reliability, and compliance.
• Support internal and external inspections and audits, demonstrating strong procedural adherence and readiness.

Knowledge, Skills, And Abilities

• Expertise in manufacturing operations.
• 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.

Minimum Qualifications (Must-Haves)

• High school diploma with 8 years related experience.

Preferred Qualifications

• Associate’s Degree, preferably in life sciences or engineering with 6 years of direct experience.
• BS/BA, preferably in life sciences or engineering with 4 years of direct experience.
• Military experience of equivalence.

Work Schedule and Environment

• This is a 24/7 operational facility; flexibility with working hours may be required.

Physical Requirements and Working Environment

• Ability to discern audible cues.
• Ability to stand for prolonged periods.
• Ability to sit for prolonged periods.
• Ability to conduct activities using repetitive motions (wrists, hands, and/or fingers).
• Ability to move objects up to 10 lbs and 33 lbs.
• May work at heights greater than 4 feet.

How You’ll Make an Impact

• Act independently to determine methods and procedures on new assignments.
• Bring creativity and effectiveness to complex tasks.
• Recommend new procedures and facilitate cross-functional collaboration to elevate operational performance.

Benefits

• Competitive compensation aligned with experience and market.
• Comprehensive health and wellness benefits (medical, dental, vision) and employee assistance resources.
• Retirement savings options.
• Paid time off and company-recognized holidays.
• Learning and development opportunities, including leadership and technical training.
• Inclusive, supportive culture with a strong focus on safety and compliance.
• Tools, resources, and support for success in a 24/7 manufacturing environment.
• Shift flexibility support and differentials where applicable.

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]).