Senior CQV Engineer: Upstream & Downstream Validation Lead

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

Job summary

FUJIFILM Biotechnologies in Holly Springs, NC is seeking a Senior CQV Engineer to lead commissioning and qualification for equipment and systems across the site. You will guide CQV teams through IV, OV, IOQ, and PQ while aligning with global standards and regulatory requirements.

You will train junior engineers, collaborate with Manufacturing, Quality, and Supply Chain, and develop SOPs and validation plans to ensure successful project integration at scale.

Qualifications

• Bachelor’s degree in Engineering required or equivalent.
• 12 years of validation activities experience for Senior Engineer II; 8 years for Senior Engineer I.
• Experience with cGMP or other highly regulated environments.

Responsibilities

• Lead CQV validation strategies and develop procedures for process support equipment.
• Manage validation lifecycle including IV, OV, IOQ, PQ through GMP release.
• Provide guidance to external validation engineers and junior staff.
• Collaborate with Manufacturing, Process Science, Automation, Supply Chain and Quality to meet validation requirements.
• Establish SOPs, VPP and VMP to ensure compliance at operations launch.
• Prepare and approve DQ, Design Reviews, SLIA, Test Matrices, Risk Assessments and IOQ Protocols.
• Lead investigations of deviations and perform RCA to develop CAPAs.
• Conduct risk assessments and implement mitigation strategies.

Skills

Effective communication

Presentation skills

MS Office

Regulatory knowledge

Cross-functional collaboration

Education

Bachelor’s degree in Engineering

Master’s degree in Engineering

Job description

FUJIFILM Biotechnologies in Holly Springs, NC is seeking a Senior CQV Engineer to lead commissioning and qualification for equipment and systems across the site. You will guide CQV teams through IV, OV, IOQ, and PQ while aligning with global standards and regulatory requirements.

You will train junior engineers, collaborate with Manufacturing, Quality, and Supply Chain, and develop SOPs and validation plans to ensure successful project integration at scale.