Engineer 3, Commissioning Qualification Validation

FUJIFILM Biotechnologies is building the future of bioproduction in Holly Springs, North Carolina. By the end of 2025, we’ll open North America’s largest end-to-end CDMO biopharmaceutical manufacturing facility, offering drug substance production, fill-finish, and packaging under one roof. We’re looking for passionate, mission-driven people to help us realize this exciting vision and deliver the next vaccine, cure, or therapy. Holly Springs combines small-town warmth with proximity to Raleigh’s thriving tech scene, making it the perfect blend of community and opportunity.

About the role

The CQV Engineer 3 supports the commissioning and qualification of equipment and systems for the site. This role performs validation activities to ensure equipment and systems comply with regulatory requirements and quality standards while ensuring successful integration of CQV activities into site projects.

Responsibilities

• Configures, tests, and validates electronic systems to ensure the systems are properly qualified and validated per standards and regulatory requirements (e.g., Food & Drug Administration (FDA))
• Reads piping & instrumentation diagrams (P&IDs) to walkthrough systems in the field
• Drafts and implements validation protocols
• Executes validation activities (e.g., equipment set up, material readiness, and work orders)
• Creates work orders, generates calibration reports, maintenance plans, and other items in the computerized maintenance management system (CMMS)
• Executes and manages validation protocols for manufacturing equipment, lab and admin, process support equipment, etc.
• Develops dashboards in Tableau to visualize and analyze CQV data to track progress and trends
• Identifies and assesses risks and escalates to senior engineers or management to develop and implement mitigation strategies
• Develops, implements, and maintains equipment and system qualifications and validation protocols
• Prepares and presents report packages for implementation into standard operating procedures (SOPs)
• Prepares validation master plans for facilities, equipment, and systems
• Provides guidance to junior engineers for drafting and implementing validation studies
• Collaborates cross-functionally to ensure successful integration of CQV activities into projects
• Other duties, as assigned

Requirements

• 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
• Temperature mapping, Thermal Data Loggers, and pre- and post-calibration procedure experience

Preferred Qualifications

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

Physical and Work Environment Requirements

• May work in Mechanical/Production spaces that may require hearing protection and enrollment in a hearing conservation program
• Will work in environment operating a motor vehicle or Powered Industrial Truck
• Ability to discern audible cues
• Ability to inspect or perform a task with 20/20 corrected vision, visual acuity, including distinguishing color