Engineer / Scientist 2 (Upstream)

Fujifilm•Holly Springs, NC

12d

About The Position

Position Overview The Engineer/Scientist 2 will provide technology transfer support and technical oversight during manufacturing operations 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

Requirements

Ability to develop effective working relationships internally and externally
Effective communication, both written and oral
Ability to provide feedback to others, including leaders
Strong problem-solving skills
Project management skills
Ability to effectively present information to others
Ability to provide standard professional advice and to create reports and analyses for review
Associate degree in Engineering, Life Science or Chemical Engineering with 4 years of related work experience (e.g., manufacturing); or Bachelor’s degree in Engineering, Life Science or Chemical Engineering with 2 years of related work experience (e.g., manufacturing); or Master’s degree with no prior experience
Experience using quality systems (e.g., deviation management, change control, CAPA, document management system)
Ability to discern audible cues.

Nice To Haves

Experience working in a Good Manufacturing Practices (GMP) environment

Responsibilities

Leads and supports technology transfer (TT) sub-team activities by conducting lab and pilot plant experiments
Collaborates and leads execution of sampling protocols, as directed
Participates in writing and reviewing master batch records (MBRs) and standard operating procedures (SOPs)
Supports training of manufacturing staff
Supports training members of the process sciences group on the use of equipment in the lab and pilot plant areas
Analyzes and summarizes lab data for clients
Writes process performance qualification (PPQ) protocols and reports
Supports and leads TT within unit operation, as directed
Interprets and communicates results to the TT team
Provides technical support for troubleshooting, process assessments, and execution of root cause analysis (RCA) and corrective and preventive action (CAPA) in response to process deviations
Writes reports and aids in closing out deviations
Provides process training and consultation on topics related to manufacturing and process
Provides input to technical risk assessments for new manufacturing processes
Contributes to the management of manufacturing data (i.e., databasing) and the statistical analysis aimed at process monitoring and resolution of investigations
Collaborates with the manufacturing department to support commercial and clinical manufacturing campaigns, including on-floor support
Supports continuous improvement projects, in partnership with manufacturing when applicable, to improve manufacturability, reliability, yield and cost
Manages lab equipment
Collaborates with colleagues to develop lab scale protocols
Executes and oversees sampling plans for lab runs
Serves as on-call for lab issues and concerns
Other duties, as assigned