Engineer 2, MSAT

Position Overview

Join a mission-driven team ensuring that every batch is safe, consistent, and inspection-ready. As an Engineer/Scientist 2 on our Process Validation team, you’ll help design, execute, and document robust validation strategies-partnering across Tech Transfer, Manufacturing, Quality, and Engineering to keep processes reproducible under normal operating conditions.

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

About Us

We are a science-led biomanufacturing organization committed to patient safety, product quality, and operational excellence. We:

• Champion data-driven, risk-based decision-making and continuous improvement
• Foster an inclusive, respectful culture where diverse perspectives strengthen outcomes
• Collaborate closely across functions to enable reliable commercial and clinical supply
• Invest in learning, mentorship, and professional development

Responsibilities

• Support the team with process validation requirements across equipment, systems, and manufacturing processes
• Ensure regulatory compliance; assess change notifications related to process validation
• Contribute to process validation strategy and execute all aspects of validation, including:
  • Process Performance Qualification (PPQ) runs
  • Continued Process Verification (CPV)
  • Other validation studies, as needed
• Collaborate with Validation/CQV to support Performance Qualification (PQ) execution and at-scale assessments (e.g., worst-case soiling for cleaning validation, microbial hold, mixing validation)
• Support process sub-teams throughout Technology Transfer (TT) phases
• Facilitate generation of sampling plans for Process Validation Reports (PVRs) and investigations
• Write and review documentation (e.g., validation campaign summaries, PPQ protocols and reports, impact assessments) for internal and external audiences
• Contribute to developing and implementing training for manufacturing staff on process validation requirements
• Support troubleshooting, process impact assessments, Root Cause Analysis (RCA), and Corrective and Preventive Actions (CAPA) in response to critical deviations, as needed
• Support TT stage-gate reviews for manufacturing readiness (e.g., process characterization and validation, risk assessments and mitigation, robust supporting data for proposed changes)
• Support creation of master plans, viral segregation risk assessments, process risk assessments, contamination control strategy, and extractables/leachables assessments; contribute to relevant site procedures and policies
• Participate in continuous improvement initiatives with Manufacturing, Quality, Engineering, and Global teams (as applicable) to improve manufacturability, reliability, yield, and cost
• Collaborate with Manufacturing to support commercial and clinical campaigns, including on-floor support
• Perform other duties, as assigned

Minimum Qualifications

• Bachelor’s degree in Engineering, Life Science, or Chemical Engineering with 2 years of relevant industry experience; or
• Master’s degree in Engineering, Life Science, or Chemical Engineering with no previous experience

Preferred Qualifications

• Experience using Quality Systems (e.g., deviation management system, change control, CAPA, document management system)
• Experience using risk management and RCA tools
• Experience working in a Good Manufacturing Practices (GMP) environment
• Prior drug substance manufacturing experience, including process validation

Knowledge, Skills, and Abilities

• Knowledge of regulatory audits and inspections and requirements (e.g., FDA 21 CFR Part 11)
• Understanding of GMP, GLP, and GDP requirements
• Knowledge of validation principles and techniques (IQ, OQ, PQ)
• Strong problem-solving and project management skills
• Excellent communication and teamwork skills; ability to present information clearly and adapt style to different audiences
• Ability to provide constructive feedback to peers and leaders

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 ([email protected]).