CQV Engineer 3

Join FUJIFILM in Holly Springs, NC (onsite) as a CQV Engineer 3. In this role, you will help ensure equipment and systems are commissioned and qualified in line with regulatory requirements and quality standards, supporting reliable execution across facilities and manufacturing operations. You will also take ownership of validation documentation and reporting, including protocols, dashboards, and work orders, to strengthen visibility and traceability throughout CQV activities.

What you’ll do

• Configure, test, and validate electronic systems to confirm proper qualification and validation against established standards and regulatory requirements, including Food & Drug Administration (FDA).
• Review piping & instrumentation diagrams (P&IDs) and perform field walkthroughs to support validation planning and execution.
• Draft and implement validation protocols, then execute validation activities such as equipment set up, material readiness, and related work orders.
• Manage and execute validation protocols for manufacturing equipment, lab and admin systems, process support equipment, and other scoped systems.
• Create work orders and generate calibration reports, maintenance plans, and other documentation within the computerized maintenance management system (CMMS).
• Develop Tableau dashboards to visualize and analyze CQV data, tracking progress and trends over time.
• Identify and assess risks, then escalate to senior engineers or management to support development and implementation of mitigation strategies.
• Develop, implement, and maintain equipment and system qualifications and validation protocols.
• Prepare report packages for integration into standard operating procedures (SOPs).
• Create validation master plans for facilities, equipment, and systems.
• Provide guidance to junior engineers on drafting and implementing validation studies.
• Collaborate cross-functionally to integrate CQV activities into site projects.
• Perform other duties as assigned.

What you bring

• Bachelor’s degree in Engineering with 5 years of experience in validation activities in facilities, commissioning, and systems qualification.
• Prior experience leading teams or projects.
• Experience with temperature mapping, Thermal Data Loggers, and pre- and post calibration procedures.

Tools and technologies

• Tableau
• CMMS
• Temperature mapping
• Thermal Data Loggers

Preferred qualifications

• Master’s degree in Engineering with 3 years of experience in validation activities in facilities, commissioning, and systems qualification.
• Experience with Good Manufacturing Practices (cGMP) or work in another highly regulated industry.
• Experience with mammalian cell culture process.