Scientist 2Engineer 2, MSAT Upstream or Downstream

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 youll help design execute and document robust validation strategiespartnering 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 well open North Americas largest end-to-end CDMO biopharmaceutical manufacturing facility offering drug substance production fill-finish and packaging under one roof.

Were 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 were proud to cultivate a culture that will fuel your purpose energy and drivewhat we call Genki. Ready to shape the future of medicine Lets transform healthcare together!

Holly Springs North Carolina combines small-town warmth with proximity to Raleighs thriving tech scene making it the perfect blend of community and opportunity.

Fujifilm is globally headquartered in Tokyo with over 70000 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: 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

• Bachelors degree in Engineering Life Science or Chemical Engineering with 2 years of relevant industry experience; or
• Masters 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 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 committedto 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 ().

Required Experience:

IC