Senior Process Validation Engineer – PPQ & GMP Expert

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

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