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Project Galaxy: Engineering CQV Services

Large Scale Cell Culture Manufacturing

Overview

The Fujifilm Holly Springs site (FDBN) is a cutting-edge greenfield facility purpose-built for large-scale cell culture manufacturing of bulk drug substances. The facility features 8 x 20,000L bioreactors and will be fully equipped with automated fill-finish, assembly, packaging, and labeling capabilities, significantly expanding manufacturing capacity.

Sequence Scope: Engineering CQV Services

Lead the overall planning, coordination, and execution of CQV activities, ensuring that all phases from commissioning to qualification and validation are completed successfully.
  • Liaise with Design/CM/CQV/Automation/Process/SMEs/Ops/Maintenance/PMs to ensure all upstream systems are managed appropriately for the entire Project Lifecycle.
  • Ensure commissioning readiness of all upstream/downstream systems to support equipment start-up and IOQ testing
  • Develop detailed Set-To-Work protocols for ~700 Direct Impact Systems that encompass taking systems from Mechanical Completion to Commissioning and Qualification readiness
  • Support generation of all CQV upstream/downstream documentation – FAT wraparounds, DQ, RTM, QRA, SAT/IOC and IOQ, including final Reports
  • Ensure commissioning readiness of all upstream/downstream systems to support equipment start-up and IOQ testing
  • Conduct risk assessments related to CQV activities. Develop and implement strategies to mitigate identified risks and ensure the project stays on track
  • Lead multiple project teams with 10+ members responsible for IV walkdowns, CTU mapping, qualifying direct impact systems and equipment
Client
Fujifilm Biotechnologies
Location
Holly Springs, MA
Large Scale Cell Culture

Life Impact

  • Fujifilm’s has made a total global investment of over $8 billion to expand their contract development and manufacturing organization (CDMO) business which underscores the unwavering commitment to advancing life sciences for their partners, people, and patients. The new commercial-scale manufacturing hub in the U.S. highlights Fujifilm’s dedication to supporting partners in delivering biologic medicines targeting complex diseases.
  • Fujifilm Biotechnologies in Holly Springs works with several companies, including Johnson & Johnson, Regeneron Pharmaceuticals, and argenx. As a contract development and manufacturing organization (CDMO), Fujifilm provides manufacturing services for these companies, which use the facility to produce their biologic medicines.

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