MSAT Process Validation Scientist/Engineer (UP/DOWN)

FUJIFILM Electronic Materials (Europe) N.V.; Holly Springs, Northern (NC, KY); Hybrid; USD 90,000 - 120,000; Full time

Benefits offered by this job

Hybrid work eligibility

Job summary

FUJIFILM Biotechnologies in Holly Springs, NC, is seeking an Engineer/Scientist 2 to design, execute, and document validation strategies across Tech Transfer, Manufacturing, Quality, and Engineering. You will help ensure reproducible processes under normal operating conditions and contribute to continuous improvement initiatives.

The role supports hybrid work eligibility and collaboration across cross-functional teams to enable reliable commercial and clinical supply, with emphasis on

Qualifications

• Must have experience with GMP environments and validation principles (IQ/OQ/PQ).
• Familiarity with regulatory audits and quality systems is preferred.
• Strong communication and cross-functional collaboration skills.

Responsibilities

• Support process validation requirements across equipment, systems, and manufacturing processes.
• Contribute to validation strategy and execute PPQ and CPV efforts.
• Collaborate with TT, Manufacturing, Quality, and Engineering for readiness and data integrity.
• Develop sampling plans for Process Validation Reports and assist investigations.
• Assist in training manufacturing staff on validation requirements.

Skills

Quality systems

GMP knowledge

Problem solving

Communication

Education

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

Master’s degree in Engineering, Life Science, or Chemical Engineering

Tools

CAPA

Deviation management

Change control

Job description

FUJIFILM Biotechnologies in Holly Springs, NC, is seeking an Engineer/Scientist 2 to design, execute, and document validation strategies across Tech Transfer, Manufacturing, Quality, and Engineering. You will help ensure reproducible processes under normal operating conditions and contribute to continuous improvement initiatives.

The role supports hybrid work eligibility and collaboration across cross-functional teams to enable reliable commercial and clinical supply, with emphasis on