Fujifilm-posted 7 days ago
Full-time • Mid Level
Onsite • College Station, TX
501-1,000 employees

The Computer System Validation (CSV) Engineer II, under general direction, will be responsible for drafting and executing validation protocols for computer systems, process control systems, as well as preparing validation final reports and all applicable lifecycle documentation. The work we do at FUJIFILM Biotechnologies Texas has never been more important—and we are looking for passionate, mission-driven people like you who want to make a real difference in people’s lives. From developing the next vaccine to advancing cell and gene therapies, we collaborate with industry leaders to tackle complex challenges and deliver meaningful solutions. If you’re ready to help transform the future of medicine, join FUJIFILM Biotechnologies. We offer a flexible work environment and we’re proud to cultivate a culture that will fuel your passion, energy, and drive—what we call Genki. Our state-of-the-art biomanufacturing facility is located in in College Station, Texas, which combines a small-town feel with vibrant culture, top-notch schools, and close proximity to big city life. Nestled between major hubs, it’s a dynamic location that blends convenience with innovation. 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.”

  • Generate, obtain approvals and execute validation deliverables for computerized systems and relevant infrastructure, including Validation Plans, Requirements Specification, Risk Assessments, Installation/Operational Qualifications, Traceability Matrices, and Validation Final Reports, ensuring documents meet regulatory and procedural requirements of 21 CFR Part-11, Annex-11 Data Integrity and GAMP5 among others.
  • Plan and organize validation activities amongst cross functional groups; capable of providing and maintaining status updates for validation activities related to day-to-day operations or project work
  • Able to work independently with minimum guidance from Sr. Engineers and/or CSV Manager (author protocol, execute, analyze data, author reports).
  • Must be able to review all System Delivery Life Cycle (SDLC) deliverables, provide constructive feedback, and ensure that the deliverables adhere to associated Standard Operating Procedures (SOPs).
  • Must be able to create, review, and update SOPs, forms, templates, documentation and files.
  • Performs all job duties and responsibilities in a compliant and ethical manner and in accordance with all applicable laws, regulation and industry codes.
  • Perform other duties as assigned.
  • Working knowledge of engineering principles.
  • Working knowledge and expertise in computerized systems validation.
  • Computer System Validation experience with DCS, SCADA and BMS systems such as DeltaV, Factory Talk View, Desigo, Unicorn, Wonderware is preferred.
  • Familiarity with 21 CFR Part 11, Annex 11, Data Integrity, GAMP5 and FDA industry regulations.
  • Excellent written and oral communication skills.
  • Working knowledge and experience in Microsoft Office products (Outlook, Word, Excel, Power Point).
  • Ability to work with minimal supervision.
  • Desire to work in fast-paced, state of the art, alternately research and customized manufacturing facility.
  • Role model for company core values of trust, delighting our customers, and Gemba.
  • Bachelor’s Degree with 3+ years of experience working with computer systems validation in the pharmaceutical, biotechnology, or related industry; OR, Associates Degree with 5+ years of experience working with computer systems validation in the pharmaceutical, biotechnology, or related industry.
  • Knowledge of DeltaV automation platform.
  • Preferably in FDA-regulated environments.
  • Bachelor’s Degree in Engineering Discipline or Science Discipline
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