Sr Computer System Validation

2 months ago

Raleigh, United States FUJIFILM Diosynth Biotechnologies Full time

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.

About This Role

The Senior IT Engineer 2, CSV is the Subject Matter Expert (SME) and leads tasks associated with Computer System Validation (CSV). This role provides input and determine action items on all GxP Manufacturing and IT Computerized Systems as well as prepares validation documentation, maintains a

validated state, with a focus on consistent policy administration. Additionally, this role works closely with other workstreams at FDBN and IT departments at other locations to align strategies and procedures. This role facilitates improvement initiatives, supports regulatory agency, and third party inspections, as needed.

What You’ll Do

  • Ensures that CSV is conducted in a consistently high standard, within budget, and that objectives are met on time for the company's objectives
  • Provides plans for the qualification of the Drug Substance Manufacturing (DSM), Drug Product (DP), Finished Goods Manufacturing (FGM), and IT Computerized Systems
  • Leads and initiates the development of documents, processes, and procedures of the CSV program
  • Generates, reviews, and approves Manufacturing and IT Computerized Systems lifecycle documentation (e.g., risk and impact assessments, user requirement specifications, functional specifications, traceability matrices, qualification protocols, validation plans, and validation summary reports)
  • Maintains the validation status of Manufacturing and IT Computerized Systems
  • Manages the allocation of contract CSV resources and monitors the quality of their deliverables to support local IT projects
  • Collaborates and aligns with other FUJIFILM Diosynth Biotechnologies sites for CSV processes and practices
  • Coordinates with Computer System vendors, as needed
  • Assesses the impact of Computer System modifications and maintains change control
  • Leads CSV team to produce high quality deliverables aligning to FDB’s IT Quality Management Systems (QMS)
  • Identifies and drives process improvement and implementation ideas to improve efficiencies
  • Other duties, as assigned

Basic Requirements

  • Bachelor’s degree in Chemical Engineering, Computer Engineering, Computer Science, Biological Science, or related fields, with 8 years of direct CSV experience in a cGMP pharmaceutical facility working with FDA regulations
  • Experience in Drug Substance Manufacturing (DSM), Drug Product (DP), and/or Finished Goods Manufacturing (FGM)
  • Prior experience leading projects and/or teams
  • Effective communication, both written and verbal
  • Collaborative attitude working with global peers and cross-functional teams toward company and department goals
  • Ability to prioritize and work autonomously based on common goals and objectives
  • Strong analytical detail and problem-solving
  • Ability to lead through assignment of work tasks, development of project schedules, and management of timelines
  • Knowledge of Kneat validation software, IT Systems, including basic software and hardware principles, implementation options (on prem, cloud, etc.) and validation methodologies including ASTM2500, GAMP5, Data Integrity, and application of 21 CFR Part 11/Annex11
  • Ability to travel domestic and international, up to 10%

Preferred Requirements

  • Master’s degree in Chemical Engineering, Computer Engineering, Computer Science, Biological Science, or related fields, with 6 years of direct Computer System Validation experience in a cGMP pharmaceutical facility working with FDA regulations
  • Prior experience working in a CDMO environment


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.

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