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Validation Engineer-CQV Engineer

2 months ago

Raleigh, United States FUJIFILM Diosynth Biotechnologies Full time

Overview

Follow Your Genki to North America's largest, state-of-the-art Life Science Manufacturing Facility & CDMO

The work we do at FDB has never been more important—and we are looking for talented candidates to join us. We are growing our locations, our capabilities, and our teams, and looking for passionate, mission-driven people like you who want to make a real difference in people’s lives. Join FDB and help manufacture the next vaccine, cure, or gene therapy in partnership with some of the most innovative biopharma companies across the globe. We are proud to cultivate a culture that will fuel your passion, energy and drive - what we call Genki.

Join us

We are growing our locations and are investing more than $2 billion into establishing a new large-scale manufacturing site for biopharmaceuticals in the United States to accelerate the growth of our Bio CDMO (Contract and Development Manufacturing Organization) business. This will be the largest end-to-end cell culture CDMO provider in North America.

The new site will offer end-to-end solutions to our customers looking to manufacture biopharmaceuticals in the US. In addition to drug substance manufacture, it will also provide automated fill-finish and assembly, packaging, and labeling services. The new state-of-the-art facility is located in Holly Springs, North Carolina, United States.

External US

About the Role:

The CQV Engineer 2 supports the commissioning and qualification of equipment and systems for the site. This role coordinates with the CQV team to perform validation activities to include but not limited to equipment set up, building dashboards, and reading and reviewing documents. This role ensures equipment and systems comply with regulatory requirements and quality standards.

Major Accountabilities:

  • 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
  • Coordinates the execution of 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 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 potential risks and escalates to senior engineers or management for resolution
  • Creates, implements, and maintains equipment and system qualifications and validation protocols
  • Prepares and presents report packages for implementation into standard operating procedure (SOPs)
  • Prepares validation master plans for facilities, equipment, and systems
  • Other duties, as assigned

Basic Requirements:

  • Bachelor’s degree in Engineering with 2 years of experience in validation activities in facilities, commissioning, and systems qualifications

Preferred Requirements:

  • Master’s degree in Engineering with no prior experience
  • Prior experience with Good Manufacturing Practices (cGMP) or working in another highly regulated industry
  • Prior experience with mammalian cell culture process

FDBN is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability, protected veteran status, sexual orientation, gender identify or any other protected class. If an accommodation to the application process is needed, please email FDBN_PNC@fujifilm.com.

To all agencies: Please, no phone calls or emails to any employee of FUJIFILM about this requisition. All resumes submitted by search firms/employment agencies to any employee at FUJIFILM via-email, the internet or in any form and/or method will be deemed the sole property of FUJIFILM, unless such search firms/employment agencies were engaged by FUJIFILM for this requisition and a valid agreement with FUJIFILM is in place. In the event a candidate who was submitted outside of the FUJIFILM agency engagement process is hired, no fee or payment of any kind will be paid.