Manufacturing Associate 5 - Column Packing

Merck & Co.; Holly Springs (NC); On-site; USD 75,000 - 110,000; Full time

Job summary

Fujifilm Biotechnologies in Holly Springs, NC is seeking a Senior Manufacturing Associate to lead day-to-day operations on a 24/7 bulk drug substance manufacturing floor and help bring our new facility fully operational.

You will champion cGMP compliance, coach teammates, supervise production steps, and collaborate on commissioning, qualification, validation, and continuous improvement projects to ensure timely delivery of therapies.

Qualifications

• High school diploma or GED with 8 years of experience in life sciences manufacturing or equivalent.
• Associate degree with 6 years of experience in life sciences manufacturing.
• BA/BS, preferably in Life Sciences or Engineering, with 4 years of experience in life sciences manufacturing.
• Equivalent military experience.

Responsibilities

• Lead day-to-day operations on a 24/7 manufacturing floor.
• Support commissioning and qualification of equipment.
• Create and/or review procedures and SOPs.
• Help onboard manufacturing staff and transfer or develop manufacturing business processes.
• Support new item creation and single-use assembly transfer or design.
• Champion safety culture and follow EHS protocols.
• Lead, execute, and document manufacturing processing steps and support activities within your area.
• Monitor and control processes with in-process testing.
• Execute validation protocols per cGMP SOPs and provide approvals as needed.
• Maintain training and qualifications; mentor junior associates.
• Support daily floor scheduling and back-up to supervisor.
• Lead troubleshooting for operational issues to restore production.
• Assist supervisor with shift huddles and investigations.
• Serve as area lead for cycle counts and materials management.

Skills

cGMP knowledge

Leadership

Troubleshooting

Education

High school diploma or GED + 8 years experience

Associate degree + 6 years experience

BA/BS in Life Sciences or Engineering + 4 years

Equivalent military experience

Job description

Position Overview

Join a high-growth biologics manufacturing team that’s bringing lifesaving therapies from concept to clinic. As a Senior Manufacturing Associate, you’ll lead day-to-day operations on a 24/7 manufacturing floor and play a hands‑on role in getting our new facility fully operational. If you love cGMP precision, coaching teammates, and solving problems on the fly, this is your next move.

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

What you’ll do

During the project phase, you will:

• Serve as a key contributor for operational readiness in bulk drug substance manufacturing.
• Support commissioning and qualification of equipment.
• Create and/or review procedures and SOPs.
• Help onboard manufacturing staff and transfer or develop manufacturing business processes.
• Support new item creation and single‑use assembly transfer or design.

In routine operations, you will:

• Champion a strong safety culture and strictly follow EHS protocols.
• Lead, execute, and document manufacturing processing steps and support activities within your functional area, ensuring adherence to SOPs and cGMP regulations.
• Monitor and control processes, performing and/or overseeing in‑process testing (pH, conductivity, visual inspections).
• Execute validation protocols per cGMP SOPs and provide approvals as a backup to the supervisor.
• Maintain all required training and qualifications; train and mentor junior associates to elevate team capabilities.
• Support daily floor scheduling and act as a back‑up to the supervisor as needed.
• Lead troubleshooting for operational issues to restore steady‑state production.
• Assist the supervisor with shift huddles, tiered escalations, investigations, and continuous improvement projects.
• Serve as area lead for cycle counts and materials management.
• Perform other duties as assigned to meet production goals.

What you bring

Minimum education and experience (one of the following)

• High school diploma or GED with 8 years of experience in life sciences manufacturing, OR
• Associate degree with 6 years of experience in life sciences manufacturing, OR
• BA/BS, preferably in Life Sciences or Engineering, with 4 years of experience in life sciences manufacturing, OR
• Equivalent military experience.

Plus:

• Proficient understanding of cGMP regulations and pharmaceutical industry standards.
• Fully qualified in a functional area (e.g., Drug Product Formulation and Filling, Weigh and Dispense, Cell Culture, or Purification) and subject‑matter expertise across all unit operations within that area (e.g., Inoculation, Seed Train, Production Bioreactor).

Preferred:

• Bioworks Certification.

Why you’ll love it here

• Make a direct impact on patients by ensuring reliable, compliant manufacturing of critical therapies.
• Work with state‑of‑the‑art technologies and single‑use systems in a collaborative, safety‑first environment.
• Grow your leadership skills by mentoring others and acting as a back‑up to the supervisor.

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]).