Engineer / Scientist 2, Process Validation

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 0-1 years of experience
  
  

Preferred 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
• 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).