Senior Process Validation Engineer — PPQ & Compliance

FUJIFILM Healthcare Americas Corporation; Holly Springs (NC); On-site; USD 120,000 - 160,000; Full time

Job summary

FUJIFILM Biotechnologies in Holly Springs, NC is seeking a Senior Engineer or Scientist of Process Validation. You will design, execute, and document validation protocols for equipment, systems, and manufacturing processes, ensuring regulatory compliance and robust, reproducible operations.

You will partner with CQV for performance qualification and continued process verification, support technology transfer, and lead or contribute to CAPA and RCA investigations.

Qualifications

• Bachelor's degree in Engineering, Life Science or Chemical Engineering with 8 years of relevant experience
• Master's degree in Engineering, Life Science or Chemical Engineering with 6 years of relevant experience
• Experience with process validation, PPQ, and continued process verification
• Experience with regulatory audits/inspections and FDA 21 CFR part 11
• Knowledge of regulatory filings support

Responsibilities

• Oversees and supports process validation requirements and regulatory compliance
• Leads development and execution of process validation strategy including PPQ runs and CPV
• Partners with CQV for at-scale validation and assessments
• Supports technology transfer phases and TT stage gates
• Generates sampling plans for PVRs and investigations
• Documents validation campaigns, PPQ protocols and reports; supports training for manufacturing staff
• Leads RCA and CAPA investigations for critical deviations
• Acts as SME for TT stage gate reviews and manufacturing readiness

Skills

Process validation

Regulatory compliance

PPQ execution

Technology transfer

CAPA

Root cause analysis

Documentation

SME leadership

Education

Bachelor's degree in Engineering/Life Science/Chemical Engineering

Master's degree in Engineering/Life Science/Chemical Engineering

Job description

FUJIFILM Biotechnologies in Holly Springs, NC is seeking a Senior Engineer or Scientist of Process Validation. You will design, execute, and document validation protocols for equipment, systems, and manufacturing processes, ensuring regulatory compliance and robust, reproducible operations.

You will partner with CQV for performance qualification and continued process verification, support technology transfer, and lead or contribute to CAPA and RCA investigations.