Process Validation Engineer II

FUJIFILM; Holly Springs (NC); Presencial; USD 85.000 - 110.000; Tempo integral

Resumo da vaga

FUJIFILM Biotechnologies in North Carolina seeks an Engineer/Scientist 2 to design, execute, and document robust process validation strategies. You will partner with Tech Transfer, Manufacturing, Quality, and Engineering to ensure reproducible processes under normal operations.

The role emphasizes validation execution, regulatory compliance, and continuous improvement in a biomanufacturing setting. Join a mission-driven team advancing biopharma manufacturing.

Qualificações

• Minimum: Bachelor’s in Engineering, Life Science, or Chemical Engineering with 2 years of experience; or Master’s with none.
• Experience with GMP, quality systems, deviation management, change control, CAPA, and document management.
• Familiarity with risk management, RCA tools, and regulatory audits.

Responsabilidades

• 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, CPV, and other studies.
• Collaborate with TT, Manufacturing, Quality, and Engineering during tech transfer.
• Prepare sampling plans for PVRs and investigations; write validation docs for internal/external audiences.
• Assist in training manufacturing staff on validation requirements.
• Support RCA and CAPA in response to deviations and participate in TT stage-gate reviews.

Conhecimentos

Regulatory knowledge

GMP exposure

Quality systems

Risk management

Root cause analysis

Project management

Communication

Formação

Bachelor’s degree in Engineering/Life Science/Chemical Eng

Master’s degree in Engineering/Life Science/Chemical Eng

Descrição da vaga

FUJIFILM Biotechnologies in North Carolina seeks an Engineer/Scientist 2 to design, execute, and document robust process validation strategies. You will partner with Tech Transfer, Manufacturing, Quality, and Engineering to ensure reproducible processes under normal operations.

The role emphasizes validation execution, regulatory compliance, and continuous improvement in a biomanufacturing setting. Join a mission-driven team advancing biopharma manufacturing.