Manufacturing Associate 5 - Upstream/Downstream (Day Shift)

Fujifilm•Holly Springs, NC

About The Position

This role will lead and execute manufacturing processing steps, associated activities, and assist the supervisor as required. This role operates on a 2-2-3 schedule for Night Shift- 6P-6A. 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 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).

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

Nice To Haves

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

Responsibilities

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.