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Added 2 mins ago
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…and control. This job family works cross-functionally in the development and implementation of prevention-based methodologies used in designing, manufacturing, testing, and correction of…
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Associate Software Engineer
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Fujifilm

Engineer 2, MSAT

Holly Springs, NC, United States

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Job details

Experience: Bachelor’s degree in Engineering, Life Science, or Chemical Engineering with 2 years of relevant industry experience; or
Posting language: English
Posted: Oct 8, 2026

Original job description

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 (FDBN_PNC@fujifilm.com).

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Posted Date 1 month ago (10/7/2026 3:17 PM)

Requisition ID 2026-39003

Job Locations US-NC-Holly Springs

Category Manufacturing

Company (Portal Searching) FUJIFILM Biotechnologies

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More about this job

Skills

Inspection
Chemical engineering
Quality control systems
Document management
Risk management
Good manufacturing practices
Good laboratory practices
SAP IQ
Problem solving
Project management
Communication skills
Teamwork
Give constructive feedback
ICIMS

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