Manufacturing Support Associate 2, Drug Product

Fujifilm • Holly Springs, NC

5d

About The Position

Position Overview The Manufacturing Support Associate 2 provides reliable support to the Drug Product Manufacturing operation during the establishment of the facility and processes. This position supports the creation of standard operating procedures, processes, trainings and documentation along with supporting tech transfer, batch planning, documentation updates and coordination of non‐batch activities including changeover, PMs, deviation management and audit preparation. 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, support operational readiness initiatives as well as site commissioning and qualification Owns and drives drug product operational readiness document plan, contribute to preparation of standard operating processes (SOPs) and documentation packages as defined by the project plan Participates in operational readiness project meetings and support factory acceptance testing (FAT) and site acceptance testing (SAT), as required Actively participates in establishment of batch handling processes for Drug product manufacturing Executes and drives minor projects and initiate change management request including optimization projects Leads and guides shop floor deviation investigation from initiation through closure Provides training and mentor junior level team members Perform other duties as assigned

Requirements

• High School Diploma or GED with 6 years direct experience OR Associate’s degree with 4 years of direct experience OR Bachelor’s degree with 2 years of direct experience OR Equivalent Military training or experience

Nice To Haves

• Associate degree in life sciences
• BA/BS, in life sciences or engineering
• Prior cGMP experience from a pharmaceutical production environment
• Preferable operational experience with formulation, filling and visual inspection processes and production equipment
• BioWorks or BTEC Capstone cGMP coursework preferred

Responsibilities

• During the project phase, support operational readiness initiatives as well as site commissioning and qualification
• Owns and drives drug product operational readiness document plan, contribute to preparation of standard operating processes (SOPs) and documentation packages as defined by the project plan
• Participates in operational readiness project meetings and support factory acceptance testing (FAT) and site acceptance testing (SAT), as required
• Actively participates in establishment of batch handling processes for Drug product manufacturing
• Executes and drives minor projects and initiate change management request including optimization projects
• Leads and guides shop floor deviation investigation from initiation through closure
• Provides training and mentor junior level team members
• Perform other duties as assigned

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Education Level: High school or GED