CQV Lead Engineer: Validation Strategy & Commissioning

FUJIFILM; Holly Springs (NC); On-site; USD 120,000 - 190,000; Full time

Job summary

FUJIFILM Biotechnologies in Holly Springs, NC seeks a Sr CQV Engineer to lead commissioning and qualification of process support equipment and systems, guiding the CQV team through the validation lifecycle and ensuring alignment with global standards and regulatory quality requirements.

You will train junior engineers, collaborate with manufacturing, quality, automation and supply chain, and establish SOPs, VPP, and VMP to support successful site launches.

Qualifications

• Bachelor’s degree in Engineering.
• 8 years of experience in validation activities in facilities, commissioning, and systems qualifications.
• Experience with cGMP or working in another highly regulated industry.

Responsibilities

• Lead validation strategies for process support equipment and develop procedures aligned with regulatory requirements.
• Manage validation lifecycle for IV, OV, IOQ, PQ through GMP release.
• Provide technical support and lead external validation engineers through commissioning, qualification and validation of Large-Scale Biologics facilities and equipment.
• Collaborate with cross-functional teams to inform and influence validation programs and incorporate global standards at the site level.
• Establish Validation SOPs, Validation Project Plan (VPP), and Validation Master Plan (VMP) to ensure full cGMP compliance.
• Lead investigations of deviations or discrepancies with RCA and implement corrective and preventive actions (CAPAs).
• Perform change control validation assessments for new systems and changes to existing qualified systems.
• Conduct impact and risk assessments and implement mitigation strategies.
• Provide guidance and training to junior engineers for all CQV-related activities.
• Other duties, as assigned

Skills

CQV Leadership

Validation lifecycle

GMP/CGMP

Cross-functional collaboration

Training junior engineers

Education

Bachelor’s degree in Engineering

Master’s degree in Engineering

Job description

FUJIFILM Biotechnologies in Holly Springs, NC seeks a Sr CQV Engineer to lead commissioning and qualification of process support equipment and systems, guiding the CQV team through the validation lifecycle and ensuring alignment with global standards and regulatory quality requirements.

You will train junior engineers, collaborate with manufacturing, quality, automation and supply chain, and establish SOPs, VPP, and VMP to support successful site launches.