Sr. Engineer 1, Process Validation

Fujifilm

Job Location:

Holly Springs, MS - USA

Monthly Salary: Not Disclosed

Posted on: 2 days ago

Vacancies: 1 Vacancy

Job Summary

Position Overview

The Senior Engineer or Scientist of Process Validation 1 ensures that manufacturing processes meet the validation and regulatory requirements to ensure the process is robust and reproducible under normal operating conditions. This role involves designing executing and documenting process validation protocols for equipment systems and manufacturing processes. Additionally this role works closely with cross-functional teams to ensure that 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

Provides oversight and supports the team with process validation requirements
Ensures regulatory compliance assesses change notifications and provides strategic input on process validation related matters
Develops process validation strategy and leads execution of 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 execution and assessments for at-scale process validation requirements (e.g. worst-case soiling for cleaning validation microbial hold and mixing validation)
Supports process sub-teams throughout the phases of technology transfer (TT)
Leads generation of 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.
Develops and implements training for manufacturing staff on process validation requirements
Leads or supports troubleshooting process impact assessments and execution of root cause analysis (RCA) and corrective and preventive action (CAPA) in response to critical deviations as needed
Serves as subject matter expert (SME) to support 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)
As technical SME leads or 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
Leads continuous improvement projects in partnership with manufacturing Quality Engineering Global teams when applicable to improve
manufacturability reliability yield and cost
Deploys and maintains Large Scale Business Unit (LSBU) strategic roadmap for continuous and breakthrough improvements and associated
requirements
Other duties as assigned

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:

Senior IC

Position OverviewThe Senior Engineer or Scientist of Process Validation 1 ensures that manufacturing processes meet the validation and regulatory requirements to ensure the process is robust and reproducible under normal operating conditions. This role involves designing executing and documenting pr...