MSAT Process Validation Engineer/Scientist

Fujifilm; Holly Springs (NC); Hybrid; USD 90,000 - 130,000; Full time

Job summary

FUJIFILM Biotechnologies in Holly Springs, NC seeks an Engineer/Scientist 2 on the Process Validation team. You will design, execute, and document validation strategies across Tech Transfer, Manufacturing, Quality, and Engineering to ensure reproducible processes under normal operating conditions.

You will support PPQ runs, CPV, and other validation studies, collaborating across TT and CQV. This role emphasizes data-driven decision-making, training, and continuous improvement in a hybrid work

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 prior experience.
• Experience with GMP environments and quality systems is preferred.

Responsibilities

• Support process validation requirements across equipment, systems, and manufacturing processes.
• Ensure regulatory compliance; assess change notifications related to process validation.
• Contribute to validation strategy and execute PPQ runs and CPV.
• Collaborate with TT, Validation/CQV, and manufacturing to support PQ execution and at-scale tests.
• Develop sampling plans for Process Validation Reports and investigations.
• Write and review validation documentation for internal and external audiences.
• Support training of manufacturing staff on process validation requirements.
• Assist with RCA, CAPA, and deviation investigations as needed.
• Support TT stage-gate reviews for manufacturing readiness.

Education

Bachelor's degree in Engineering, Life Science, or Chemical Engineering

Master's degree in Engineering, Life Science, or Chemical Engineering with no previous experience

Job description

FUJIFILM Biotechnologies in Holly Springs, NC seeks an Engineer/Scientist 2 on the Process Validation team. You will design, execute, and document validation strategies across Tech Transfer, Manufacturing, Quality, and Engineering to ensure reproducible processes under normal operating conditions.

You will support PPQ runs, CPV, and other validation studies, collaborating across TT and CQV. This role emphasizes data-driven decision-making, training, and continuous improvement in a hybrid work