Senior CQV Engineer – Biologics Validation Lead

FUJIFILM Biotechnologies; 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 and qualification of process support equipment and systems. You will guide CQV teams through IV, OV, IOQ, and PQ activities, develop SOPs and VMPs, and ensure cGMP compliance across site projects.

You’ll collaborate with Manufacturing, Process Science, Automation, Quality, and Supply Chain, mentor junior engineers, and ensure CQV activities integrate with global standards and regulatory requirements.

Qualifications

• Bachelor's degree in Engineering required.
• 8+ years of validation experience in facilities, commissioning, and system qualifications.
• Experience with cGMP or highly regulated environments preferred.

Responsibilities

• Lead CQV activities for commissioning and qualification of equipment and systems.
• Develop and implement SOPs, VPP, and VMP to ensure cGMP compliance.
• Mentor and train junior engineers and coordinate with cross-functional teams.

Skills

CQV leadership

Validation lifecycle

GMP/regulatory knowledge

Stakeholder collaboration

Training junior engineers

Education

Bachelor's degree in Engineering

Master's degree in Engineering

Tools

Microsoft Office

GxP document systems

Job description

FUJIFILM Biotechnologies in Holly Springs, NC, seeks a Senior CQV Engineer to lead commissioning and qualification of process support equipment and systems. You will guide CQV teams through IV, OV, IOQ, and PQ activities, develop SOPs and VMPs, and ensure cGMP compliance across site projects.

You’ll collaborate with Manufacturing, Process Science, Automation, Quality, and Supply Chain, mentor junior engineers, and ensure CQV activities integrate with global standards and regulatory requirements.