Job Information
Fujifilm Engineer / Scientist 2, Process Validation in Holly Springs, North Carolina
Position Overview
The Engineer or Scientist 2 for Process Validation helps ensure that manufacturing processes meet the validation and regulatory requirements for the process to be reproducible under normal operating conditions. This role contributes to the design, execution, and documentation of process validation protocols for equipment, systems, and manufacturing processes. Additionally, this role works with cross-functional teams to help ensure processes are consistently producing high-quality products in a safe and efficient manner.
Company Overview
Follow Your Genki to North America's largest, state-of-the-art Life Science Manufacturing Facility & CDMO
The work we do at FUJIFILM Diosynth Biotechnologies has never been more important—and we are looking for talented candidates to join us. We are growing our locations, our capabilities, and our teams, and looking for passionate, mission-driven people like you who want to make a real difference in people’s lives. Join FUJIFILM Diosynth Biotechnologies and help manufacture the next vaccine, cure, or gene therapy in partnership with some of the most innovative biopharma companies across the globe. We are proud to cultivate a culture that will fuel your passion, energy and drive - what we call Genki.
Join us
We are growing our locations and are investing more than $2 billion into establishing a new large-scale manufacturing site for biopharmaceuticals in the United States to accelerate the growth of our Bio CDMO (Contract and Development Manufacturing Organization) business. This will be the largest end-to-end cell culture CDMO provider in North America.
The new site will offer end-to-end solutions to our customers looking to manufacture biopharmaceuticals in the US. In addition to drug substance manufacture, it will also provide automated fill-finish and assembly, packaging, and labeling services. The new state-of-the-art facility is located in Holly Springs, North Carolina, United States.
Job Description
What You’ll Do
Performs process impact assessments, root cause analysis (RCA) and corrective and preventive action (CAPA) in response to deviations, as directed
Supports technology transfer (TT) across multiple unit operations
Coordinates, plans, and executes manufacturing process validation runs
Facilitates generation of sampling plans for process validation reports (PVRs) and investigations
Writes documentation for internal and external use, such as process performance qualification (PPQ) protocol and reports
Participates in continuous improvement projects, in partnership with Manufacturing, Quality, Engineering, and Global teams when applicable to improve manufacturability, reliability, yield, and cost
Provides support to senior team members in all aspects of process validation, as needed
Collaborates with the manufacturing department to support commercial and clinical manufacturing campaigns, including on-floor support
Other duties, as assigned
Knowledge and Skills
Knowledge of Quality Systems (e.g., deviation management system, change control, CAPA, document management system)
Excellent communication and teamwork skills
Knowledge of risk management and RCA tools
Ability to effectively present information to others
Knowledge of drug substance manufacturing, including process validation
Willingness to provide feedback to others, including leaders
Problem-solving and project management skills
Knowledge of validation principles and techniques (IQ, OQ, PQ)
Basic Requirements
Bachelor’s degree in Engineering, Life Science, or Chemical Engineering with 2 years of relevant experience; or
Master’s degree in Engineering, Life Science, or Chemical Engineering with no prior experience
Preferred Requirements
- Experience working in a Good Manufacturing Practices (GMP) environment
WORKING CONDITIONS & PHYSICAL REQUIREMENTS
Ability to ascend or descend ladders, scaffolding, ramps, etc. X No Yes
Ability to stand for prolonged periods of time. X No Yes frequency/minutes (If yes, may specify frequency/duration: up to 15, 30, 120, 240 minutes)
Ability to sit for prolonged periods of time. X No Yes frequency/minutes (If yes, may specify frequency/duration: up to 15, 30, 120, 240 minutes)
Ability to conduct activities using repetitive motions that include writs, hands and/or fingers. X No Yes
Ability to operate machinery and/or power tools. X No Yes
Ability to conduct work that includes moving objects up to X pounds. X No Yes If yes, 10 lbs. 33 lbs.
Ability to bend, push or pull, reach to retrieve materials from 18” to 60” in height, and use twisting motions. X No Yes
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 (FDBN_PNC@fujifilm.com).
Job Locations US-NC-Holly Springs
Posted Date 4 days ago (3/12/2025 11:54 AM)
Requisition ID 2025-33792
Category Process Sciences
Company (Portal Searching) FUJIFILM Diosynth Biotechnologies