Hybrid Process Validation Scientist/Engineer (MSAT)

FUJIFILM Biotechnologies; Holly Springs (NC); Hybrid; USD 85,000 - 120,000; Full time

Job summary

FUJIFILM Biotechnologies in Holly Springs, NC is seeking an Engineer/Scientist 2 for the Process Validation team. You will help design, execute, and document validation strategies to keep processes reproducible under normal operating conditions.

Role emphasizes collaboration across Tech Transfer, Manufacturing, Quality, and Engineering, with a hybrid work arrangement and a focus on patient safety, product quality, and operational excellence.

Qualifications

• Bachelor's degree in Engineering, Life Science, or Chemical Engineering with 2 years of relevant industry experience.
• Master's degree in Engineering, Life Science, or Chemical Engineering with no previous experience.

Responsibilities

• Support validation requirements across equipment, systems, and manufacturing processes.
• Ensure regulatory compliance; assess change notifications related to process validation.
• Execute validation activities including PPQ runs and CPV; other studies as needed.
• Collaborate with Validation/CQV to support PQ execution and at-scale assessments.
• Support TT stages and creation of master plans and risk assessments.
• Write and review validation documentation for internal and external audiences.
• Contribute to training on process validation requirements for manufacturing staff.
• Support CAPA, RCA, and deviations related to validation.
• Participate in TT stage-gate reviews for manufacturing readiness.

Skills

Process validation

GMP

Risk management

Documentation

Cross-functional collaboration

Education

Bachelor's in Engineering/Life Science/ChE

Master's in Engineering/Life Science/ChE

Tools

Quality Systems

Job description

FUJIFILM Biotechnologies in Holly Springs, NC is seeking an Engineer/Scientist 2 for the Process Validation team. You will help design, execute, and document validation strategies to keep processes reproducible under normal operating conditions.

Role emphasizes collaboration across Tech Transfer, Manufacturing, Quality, and Engineering, with a hybrid work arrangement and a focus on patient safety, product quality, and operational excellence.