CSV Engineer II

Position Overview

Summary:  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.

Company Overview

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.” Visit: https://www.fujifilm.com/us/en/about/region/careers

Job Description

Essential Functions:

• 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.

Required Skills & Abilities:

• 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 preferred.
• Experience in FDA-regulated environments preferred.
• Bachelor’s Degree in Engineering Discipline or Science Discipline preferred.
• 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.

Working Conditions & Physical Requirements:

The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job.  Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.  While performing the duties of this job, the employee is regularly required to:

• Experience prolonged standing, some bending, stooping and stretching.
• Use hand-eye coordination and manual dexterity sufficient to operate a keyboard, photocopier, telephone, calculator, and other office equipment is required.
• The ability to regularly lift and/or move up to 10 pounds and occasionally lift and/or move up to 50 pounds.
• Working on ladders.
• Attendance is mandatory.

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.

EEO Information

Fujifilm is committed to providing equal opportunities in hiring, promotion and advancement, compensation, benefits, and training regardless of nationality, age, gender, sexual orientation or gender identity, race, ethnicity, religion, political creed, ideology, national, or social origin, disability, veteran status, etc.

ADA Information

If you require reasonable accommodation in completing this application, interviewing, completing any pre-employment testing, or otherwise participating in the employee selection process, please direct your inquiries to our HR Department ([email protected] or (979) 431-3500).