Sr Engineer 1, Process Validation

FUJIFILM Biotechnologies; Holly Springs (NC); On-site; USD 120,000 - 180,000; Full time

Job summary

FUJIFILM Biotechnologies in Holly Springs, NC seeks a Senior Engineer/Scientist to validate manufacturing processes, ensuring they meet regulatory standards and are robust under normal operation. You’ll design, execute, and document validation protocols for equipment, systems, and processes, collaborating with cross-functional teams to deliver high-quality products.

The role requires extensive experience in process validation and regulatory affairs, with a focus on PPQ, continued process

Qualifications

• Bachelor's degree with 8+ years of relevant experience or Master's with 6+ years in engineering or related field.
• Experience with process validation and regulatory requirements (FDA, cGMP) is preferred.
• Ability to design, execute, and document validation protocols and PPQ studies.

Responsibilities

• Oversee process validation requirements and ensure regulatory compliance across validation activities.
• Develop and lead process validation strategy including PPQ runs and continued process verification.
• Partner with Validation (CQV) and cross-functional teams for scale-up and TT activities.
• Lead sampling plan generation and document validation campaigns, reports, and risk assessments.
• Support investigations, CAPA, and root cause analysis for critical deviations.

Skills

Process validation

Regulatory compliance

PPQ execution

CQA/QA collaboration

Root cause analysis

Documentation and reporting

Cross-functional teamwork

Validation strategy

Education

Bachelor's in Engineering/Life Science/Chemical Engineering

Master's in Engineering/Life Science/Chemical Engineering

Job description

The Senior Engineer or Scientist of Process Validation 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, 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

What You'll Do

• 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
• Bachelor's degree in Engineering, Life Science or Chemical Engineering with 8 years of relevant experience (e.g., engineering); or
• Master's degree in in Engineering, Life Science or Chemical Engineering with 6 years of relevant experience (e.g., engineering); or

Preferred Requirements

• Prior drug substance or manufacturing experience, including expertise in new product launch, process validation and commercialization
• Experience with regulatory audits and inspections and regulatory requirements such as FDA 21 CFR part 11
• Experience supporting or writing portions of regulatory filings

Physical And Work Environment Requirements

• Ability to discern audible cues.

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 ([e-mail]).