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Engineer 3, Process Validation

Job Location:

Holly Springs, MS - USA

Monthly Salary: Not provided by the employer

Posted: 10 August 2026 (30+ days ago)

Application Deadline: 7 November 2026

Vacancies: 1 Vacancy

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Job Summary

Position Overview

The Engineer or Scientist 3 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

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

What Youll Do:

Ensures regulatory compliance assesses change notifications and provides input on process validation related matters
Supports the team with process validation requirements
Plays a role in developing process validation strategy and executes all aspects of process validation including process performance qualification (PPQ) runs continued process verification and other validation studies
Partners with Validation (CQV) to support Performance Qualification (PQ) execution and assessments for at-scale process validation requirements (e.g. worst-case soiling for cleaning validation microbial hold and mixing validation)
Provides support to process sub-teams throughout the phases of technology transfer (TT)
Generates sampling plans for process validation reports (PVRs) and investigations
Writes and reviews documentation for internal and external use such as validation campaigns summary reports PPQ protocol and reports impact assessments etc.
Contributes to the development and implementation of training for manufacturing staff on process validation requirements
Facilitates troubleshooting conducts process impact assessments and executes root cause analysis (RCA) and corrective and preventive action (CAPA) in response to critical deviations as needed
Supports TT stage gate reviews on incoming processes for manufacturing readiness (e.g. acceptable process characterization and validation risk assessments mitigation and robust supporting data for proposed changes)
Supports generation of master plans viral segregation risk assessments process risk assessments contamination control strategy extractable and leachable assessment and other site procedures and policies
Participates in continuous improvement projects in partnership with manufacturing Quality Engineering Global teams when applicable to improve manufacturability reliability yield and cost
Other duties as assigned

Minimum Requirements:

Bachelors degree in Engineering Life Science or Chemical Engineering with 5 years of relevant experience (e.g. engineering); or
Masters degree in Engineering Life Science or Chemical Engineering with 3 years of relevant experience (e.g. engineering); or
PhD with no prior experience
Experience using Quality Systems (e.g. Deviation Management system Change Control CAPA document management system)
Experience using Risk Management and RCA tools

Preferred Requirements:

Experience working in a Good Manufacturing Practices (GMP)
environment
Prior drug substance manufacturing experience including process
validation
Experience with regulatory audits inspections and requirements
such as FDA 21 CFR part 11

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

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About Company

Fujifilm

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