Summary:  The Validation Engineer II, under moderate supervision, will be responsible for drafting System Impact Assessments (SIAs), drafting and executing validation protocols for Facilities, Utilities, Systems and Equipment (FUSE), as well as preparing validation final reports for the same.

The work we do at FUJIFILM Diosynth 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 Diosynth 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

Reports to:   Validation Manager

Location:      College Station, TX

Essential Functions:

• Generate, obtain pre-approvals/post-approvals of validation deliverables for FUSE systems and relevant infrastructure, System Impact Assessments, Installation/Operational Qualifications and Performance Qualifications (as applicable) and Validation Final Reports, ensuring documents meet regulatory and procedural requirements.
• Significant knowledge of validation FUSE System Delivery Life Cycle (SDLC) deliverables, program’s Standard Operational Procedures (SOPs), User Requirement Specifications (URS), Validation Project Plans (VPPs), and all documents and forms used to support the Validation Program. Able to discuss validation concepts with Sr. Validation Engineers-Specialists/Validation Managers for guidance, as required.
• Generate and execute requalification protocols for FUSE systems.
• Execute validation activities assigned by Sr. Validation Engineers-Specialists/Validation Managers and provide status updates on assigned validation tasks (author protocols, execute, author reports).
• Review and provide feedback on Validation Program SOPs, forms, templates.
• 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:

• Knowledge of validation principles within regulated work environments, preferably within the Pharmaceutical/Biotechnology industry.
• Understanding of ISPE Baseline 5, Vol. 2 – Commissioning and Qualification and FDA industry regulations.
• Efficient knowledge of qualification of FUSE Systems including Classified Clean Rooms, Clean Utilities, Sterilization Equipment, Temperature Controlled Units (2-8 C, -80 C, LN2 Freezers, Incubators) among others.
• Able to work in fast-paced, state of the art, alternately research and customized manufacturing facility.
• Efficient written and oral communication skills.
• Working knowledge and experience in Microsoft Office products (Outlook, Word, Excel, Power Point).

Qualifications:

• Bachelor’s Degree with 3+ years of experience in pharmaceutical, biotechnology, or related industry, preferably in FDA-regulated environments.
• Associates Degree with 5+ years of experience in pharmaceutical, biotechnology, or related industry, preferably in FDA-regulated environments.
• 1+ year of experience on Validation deliverables/tasks.

Preferred Qualifications:

• Bachelor’s Degree in Engineering Discipline or Science Discipline.

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.

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.

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 (FDBTHR@fujifilm.com or (979) 431-3500).