Manufacturing Associate 5, Downstream

Fujifilm; Holly Springs (NC); On-site; USD 90,000 - 130,000; Full time

Job summary

FUJIFILM Biotechnologies in Holly Springs, NC, seeks an experienced manufacturing lead to drive and execute bulk drug substance processing steps, support equipment commissioning, and mentor staff. This 24/7 facility requires flexibility with shifts and strong commitment to safety and cGMP compliance.

You will lead operations on the manufacturing floor, oversee in-process testing, assist the supervisor with scheduling and CI initiatives, and participate in training and process improvements with a

Qualifications

• 8+ years in life sciences manufacturing with varied educational paths.
• Strong troubleshooting and communication skills in a fast-paced setting.
• Ability to lead, train, and mentor manufacturing staff on cGMP processes.

Responsibilities

• Lead and execute manufacturing processing steps and related activities.
• Support commissioning, qualification of equipment, and process transfers.
• Oversee in-process testing and validation activities, and provide backup approvals.
• Train junior staff, schedule daily activities, and assist the supervisor with CI projects.
• Handle shift huddles, Tier escalations, and cycle counts; participate in safety culture.

Skills

Troubleshooting

Verbal communication

Written communication

Teamwork

Education

High School Diploma or GED

Associate’s Degree

Bachelor’s Degree

Equivalent Military Experience

Job description

Position Overview

This role will lead and execute manufacturing processing steps, associated activities, and assist the supervisor as required. This manufacturing facility will be 24/7 operational and the role may require to be flexible with working hours and shift rotation.

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 Project Phase:

• Key contributor in supporting the preparation for operational readiness related to bulk drug substance manufacturing.
• Supporting projects related to:
• Commissioning and qualification of equipment, procedure review and/or creation, support onboarding of manufacturing staff, development or Transfer of Manufacturing business processes, new item creation, or single-use assembly transfer or design.
• 0-25% travel (international and/or domestic) may be required.

In Operations:

• Adhere to strict safety protocols and contribute to culture of safety within the manufacturing environment. Lead, execute and document manufacturing processing steps and/or manufacturing support activities, process monitoring and control within a functional area, ensuringcompliance with Standard operating procedures (SOPs) and cGMP regulations.
• Oversee and/or perform in-process testing (pH, conductivity, visual inspection)
• Execute validation protocols. Provide approval as a backup to the supervisor.
• Maintain training to perform all required activities.
• Train and mentor junior manufacturing associates to enhance team capabilities.
• Support scheduling daily activities on the manufacturing floor and act as a back-up for the supervisor, as needed.
• Lead troubleshooting as required for operational issues.
• Assist the supervisor with shift huddles and tier escalations, investigation, and continuous improvement (CI) projects, as needed.
• Area lead for cycle counts and materials management.
• Other duties as assigned.
• This role requires shift work (weekend and potential for nights).

Who You Are

You have strong troubleshooting ability as well as verbal and written communication skills. You have the ability to adapt in a fast-paced changing environment, pivot and adjust plans accordingly. You have strong time-management skills and are able to think critically with superior problem-solving skills. You have a team-based attitude and the ability to work in a global team environment by building relationships while communicating effectively with others.

Basic Requirements

• 8 Years of experience in life sciences manufacturing with a High School Diploma or GED OR
• 6 Years of experience in life sciences manufacturing with an Associate's Degree OR
• 4 Years of experience in life sciences manufacturing with a Bachelor's Degree OR
• Equivalent Military Experience

Preferred Requirements

• Associate’s Degree
• BA/BS Degree, preferably in Life Sciences or Engineering
• Proficient understanding of cGMP regulations and pharmaceutical industry standards
• Fully qualified in a functional area (Ex: Drug Product Formulation and Filling, Weigh and Dispense, Cell Culture or Purification) while also acting as an SME on all unit operations within that functional area (i.e. Inoc, Seed Train and Production Bioreactor)
• BioWorks Certification

PHYSICAL REQUIREMENTS

PHYSICAL DEMANDS

• Will work in environment which may necessitate respiratory protection
• May work in Mechanical/Production spaces that may require hearing protection and enrollment in a hearing conservation program.
• Ability to discern audible cues

WORKING ENVIRONMENT

PHYSICAL DEMANDS

• Ability to ascend or descend ladders, scaffolding, ramps, etc.
• Ability to stand for prolonged periods of time.
• Ability to sit for prolonged periods of time.
• Ability to conduct activities using repetitive motions that include wrist, hands and/or fingers.
• Ability to conduct work that includes moving objects up to 33 lbs.
• Ability to bend, push or pull, reach to retrieve materials from 18” to 60” in height, and use twisting motions.

ENVIRONMENTAL CONDITIONS

• Will work in heights greater than 4 feet

EEO Information

Fujifilm is committedto 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]).