Engineer/Scientist 2, Process Analytics

The Engineer / Scientist 2 of Process Analytics provides technology transfer support and technical oversight during manufacturing operations as it relates to process analytics data management systems and trending purposes. This role supports senior team members in all aspects of process analytics, including but not limited to closing deviations, generating master batch records, and data system improvement initiatives.

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

• Supports site readiness, technical transfer (TT), and ongoing manufacturing by configuring and maintaining compliant trending systems, as directed
• Coordinates with cross-functional teams to deliver projects on time and in full completeness
• Builds and maintains routine statistical process control methods and multivariate models for process trending and monitoring
• Supports ad hoc statistical analysis, as needed
• Closes deviations and provides thorough findings to internal teams
• Documents process performance and product health through process trending, monitoring, and supporting annual product reviews and manufacturing campaign summary reports
• Supports technical risk assessments for new manufacturing processes from a process analytics (PA) perspective
• Trains relevant stakeholders on PA tools and respective analytical approaches (e.g., multivariate models, Process Analytical Technologies (PAT), and Statistical Process Control (SPC) methods), as needed
• Serves as on-call for PA issues and concerns
• Supports role in Good Manufacturing Practices (GMP) environment
• 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
• Supports generation and review of master batch records (MBRs) and sample plans, as needed
• Participates in site data stewardship activities by ensuring data and analyses are easily findable, accessible, interoperable, and reusable to internal and external stakeholders
• Supports informatics, data systems improvement initiatives, and evaluates new analytical technologies (e.g., PAT, data science tools) and solutions to improve scalability, manufacturability, reliability, yield and cost
• Supports the curation of critical knowledge related to PA systems and multivariate modeling
• Identifies improvement opportunities and assists in the development of business cases and improvement plans
• Participates in writing and reviewing standard operating procedures (SOPs), work instructions, protocols, and other relevant documentation
• Builds awareness of industry trends and customer requirements
• Supports the design of sampling protocols and sampling plans supporting PAT and analytics development
• Other duties, as assigned
  
  

Knowledge And Skills

• Ability to develop effective working relationships internally
• Effective communication, both written and oral
• Analytical and problem-solving, and project management skills
• Knowledge of project management concepts
• Ability to present information to others
• Knowledge of Snowflake and Python
• Familiarity with machine learning techniques, data science techniques, and PAT
• Knowledge of regulatory requirements for data integrity
• Familiarity with data analytics architectures (e.g., warehousing, distributed computing, visualization analytics)
  
  

Basic Requirements

• Bachelor’s degree in Data Science, Biotechnology, or Chemical Engineering with 2 years of relevant experience (e.g., data engineering, manufacturing, bioprocess development, PAT); or
• Master’s degree with no prior experience
• Experience using Quality Systems (e.g., Deviation Management system, Change Control, CAPA, document management system)
  
  

Preferred Requireme

• Experience working in a GMP environment
• Experience with structured query language (SQL) writing skills
• Experience with SPC and multivariate analysis
• Experience working with process historians and data management systems (e.g., OSI PI, Statistica, SIMCA)
  
  

Working Conditions & Physical Requirements

• Ability to discern audible cues.
• Ability to inspect or perform a task with 20/20 corrected vision, visual acuity, including distinguishing color.
• Ability to stand for prolonged periods of time. 30 minutes
• Ability to conduct activities using repetitive motions that include writs, hands and/or fingers.
  
  

To all agencies: Please, no phone calls or emails to any employee of FUJIFILM about this requisition. All resumes submitted by search firms/employment agencies to any employee at FUJIFILM via-email, the internet or in any form and/or method will be deemed the sole property of FUJIFILM, unless such search firms/employment agencies were engaged by FUJIFILM for this requisition and a valid agreement with FUJIFILM is in place. In the event a candidate who was submitted outside of the FUJIFILM agency engagement process is hired, no fee or payment of any kind will be paid.

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).