Engineer 3, Commissioning Qualification Validation
About The Position
The CQV Engineer 3 supports the commissioning and qualification of equipment and systems for the site. This role performs validation activities to include but not limited to equipment set up, building dashboards, creating work orders, managing protocols, and reading and reviewing documents. This role ensures equipment and systems comply with regulatory requirements and quality standards while ensuring a successful integration of CQV activities into site projects. FUJIFILM Biotechnologies is building the future of bioproduction in Holly Springs, North Carolina. By 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. We offer a dynamic work environment and we’re proud to cultivate a culture that will fuel your purpose, energy, and drive—what we call Genki. Ready to shape the future of medicine? Let’s transform healthcare together! Holly Springs, North Carolina, combines small-town warmth with proximity to Raleigh’s thriving tech scene, making it the perfect blend of community and opportunity. Fujifilm is globally headquartered in Tokyo with over 70,000 employees across four key business segments of healthcare, electronics, business innovation, and imaging. We are guided and united by our Group Purpose of “giving our world more smiles.”
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
Nice To Haves
- 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
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
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What This Job Offers
Job Type
Full-time
Career Level
Mid Level
