Manufacturing Associate 5, Downstream

FUJIFILM Biotechnologies; Holly Springs (NC); On-site; USD 85,000 - 110,000; Full time

Job summary

FUJIFILM Biotechnologies in Holly Springs, NC is seeking an experienced manufacturing professional to lead and execute processing steps in a 24/7 facility. The role requires flexibility with shift rotation and the ability to support the supervisor as needed.

Responsibilities include SOP compliance, in-process testing oversight, training, troubleshooting, and CI projects, with 0-25% travel. Ideal candidates have strong problem solving, communication, and teamwork in a GMP environment.

Qualifications

• 8+ years in life sciences manufacturing or 6+ years with an associate degree, or 4+ years with a bachelor’s degree.
• Strong knowledge of cGMP regulations and pharmaceutical industry standards.
• Ability to lead, train, and mentor manufacturing staff.

Responsibilities

• Lead and execute manufacturing processing steps and related activities.
• Oversee in-process testing and document results, ensuring SOP compliance.
• Support supervisor with shift huddles, CI projects, and escalation handling.
• Assist with scheduling, material management, and troubleshooting.
• Provide training and mentorship to junior associates.

Skills

Troubleshooting

Communication

Team leadership

Shift work

Education

Bachelor's degree in Life Sciences or Engineering

BioWorks Certification

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, ensuring compliance 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

• 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

• 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 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]).