Senior CQV Engineer - Validation Lead (GMP)

FUJIFILM; Holly Springs (NC); On-site; USD 120,000 - 180,000; Full time

Job summary

FUJIFILM Biotechnologies in Holly Springs, NC seeks a Senior CQV Engineer to lead commissioning, qualification, and validation activities for process support equipment and facilities. You will drive validation strategies, develop IOQ/PQ plans, and ensure cGMP compliance across projects.

The role requires extensive experience in validation, strong collaboration with Manufacturing, Quality, and Automation teams, and a commitment to training junior engineers to integrate CQV into site programs.

Qualifications

• Bachelor's degree in Engineering required; 8+ years in validation/CQV in regulated facilities.
• Master's degree preferred for senior-level track with broader scope.
• Experience with cGMP or other highly regulated environments.

Responsibilities

• Acts as CQV Technical Lead for process support equipment and validation strategies.
• Leads validation lifecycle for IV, OV, IOQ, and PQ through GMP release.
• Provides technical leadership to external validation engineers and cross-site teams.
• Collaborates with Manufacturing, Process Science, Automation, QA to meet CQV requirements.
• Develops SOPs, VPP, and VMP to ensure compliant site launches.

Skills

Effective communication

Presentation skills

MS Office

Regulatory knowledge

Education

Bachelor's degree in Engineering

Master's degree in Engineering

Tools

Microsoft Office

Job description

FUJIFILM Biotechnologies in Holly Springs, NC seeks a Senior CQV Engineer to lead commissioning, qualification, and validation activities for process support equipment and facilities. You will drive validation strategies, develop IOQ/PQ plans, and ensure cGMP compliance across projects.

The role requires extensive experience in validation, strong collaboration with Manufacturing, Quality, and Automation teams, and a commitment to training junior engineers to integrate CQV into site programs.