Manufacturing Support Associate 1, 2 or 3 (Experience Based)

Fujifilm•Holly Springs, NC

11d•Onsite

About The Position

The Manufacturing Support Associate performs manufacturing support activities to ensure compliant and reliable production. This manufacturing facility is 24/7 operational and the role may require to be flexible with working hours. 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, leads operational readiness initiatives as well as site commissioning and qualification efforts Supports reliable production through the following activities during regular operations Leads troubleshooting including acting as a process subject matter expert (SME) for their process respective area(s) Coordinates Batch Planning including process template creation and import and management of preventive maintenance plans (PMs) Recommends and performs Documentation updates Initiates and/or supports training, onboarding, and curriculum development and management Coordinates non-batch activities and creation of associated documentation for changeover, PMs, column packing Supports tech transfer Initiates or supports change management records, investigations, corrective and preventive actions (CAPAs), and continuous improvement (CI) activities Identifies and/or drives highly technical improvement projects in DSM Supports inspections and audits Performs other duties, as assigned

Requirements

Manufacturing Support Associate 1 High School Diploma/GED and 4 years related experience OR Associate degree in life sciences with 2 years of direct experience OR BA/BS in life sciences with no experience OR Equivalent Military training/experience
Manufacturing Support Associate 2 High School Diploma or GED and 6 years of related experience OR Associates degree with 4 years of direct experience OR BA/BS with 2 years of direct experience Equivalent Military training/experience
Manufacturing Support Associate 3 High School Diploma or GED with 8 years related experience OR Associate’s Degree with 6 years of direct experience OR BS/BA with 4 years of direct experience Equivalent military experience or training
Ability to discern audible cues
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 10 lbs.
Will work in heights greater than 4 feet

Responsibilities

During the project phase, leads operational readiness initiatives as well as site commissioning and qualification efforts
Supports reliable production through the following activities during regular operations
Leads troubleshooting including acting as a process subject matter expert (SME) for their process respective area(s)
Coordinates Batch Planning including process template creation and import and management of preventive maintenance plans (PMs)
Recommends and performs Documentation updates
Initiates and/or supports training, onboarding, and curriculum development and management
Coordinates non-batch activities and creation of associated documentation for changeover, PMs, column packing
Supports tech transfer
Initiates or supports change management records, investigations, corrective and preventive actions (CAPAs), and continuous improvement (CI) activities
Identifies and/or drives highly technical improvement projects in DSM
Supports inspections and audits
Performs other duties, as assigned