Senior Process Validation Engineer: PPQ & GMP Leader

FUJIFILM Holdings America Corporation; Holly Springs (NC); On-site; USD 110,000 - 165,000; Full time

Job summary

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

The role collaborates with cross-functional teams, supports technology transfer, and leads validation studies including PPQ runs, continued process verification, and risk assessments to enable

Qualifications

• Requires experience with process validation and regulatory requirements.
• Experience with PPQ runs, continued process verification, and validation studies is preferred.
• Regulatory filings and audits experience is a plus.

Responsibilities

• Provide oversight and support for process validation requirements and regulatory compliance.
• Develops validation strategy and leads PPQ runs and continued process verification.
• Collaborates with Validation (CQV) for at-scale validation activities.
• Supports technology transfer phases and TT stage-gate reviews.
• Leads or supports root cause analyses and CAPA in response to deviations.

Skills

Process validation

Regulatory compliance

Documentation

Cross-functional collaboration

Troubleshooting

Education

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

Master's in Engineering/Life Science/Chemical Engineering

Job description

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

The role collaborates with cross-functional teams, supports technology transfer, and leads validation studies including PPQ runs, continued process verification, and risk assessments to enable