Validation Engineer III

Fujifilm • College Station, TX

1d • $84,000 - $100,000 • Onsite

About The Position

Validation Engineer III for FUJIFILM Diosynth Biotechnologies Texas, LLC, located in College Station, TX. 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.”

Requirements

• Master’s degree in Mechanical Engineering or related engineering field and two (2) years of experience as a validation engineer or related occupation in validation engineering OR Bachelors degree in Mechanical Engineering or related engineering field and five (5) years of experience as a validation engineer or related occupation in validation engineering
• Must possess two years with a Master’s and five years with Bachelor’s in: Validation engineering in pharmaceutical, biotechnology, or related industry.
• Creating validation protocols, deviations, and validation summary reports; utilizing Validation Life Cycle Concept FUSE Systems, including Classified Clean Rooms, Clean Utilities, Sterilization Equipment, Temperature Controlled Units (2-8 C, -80 C, LN2 Freezers, Incubators)
• ISPE Baseline 5, Vol. 2 GMP, GDP, GLP practices including 21CFR Part11 & Part21 O, 50, 56, 58, EU Annex 11, ICH (IND, NDA), USP , ASME and ISPE guidelines– Commissioning and Qualification and FDA industry regulations.
• Centrifuges, cell analyzers, particle counters, cell samplers, sealers, welders, cell separators, biosafety cabinets(BSC), chromatographic system, filling/ capping machines, autoclaves, balances and others Sterilization with Steam/ VHP
• Lab Equipment (ie. HPLC, UPLCs, UVVis and pH meters)
• Utilizing temperatures mapping tools including E-Val ProNalSuite/ Kaye Systems.

Responsibilities

• Work in the areas of Facilities, Utilities, Systems and Equipment (FUSE) including Centrifuges, cell analyzers, particle counters, cell samplers, sealers, welders, cell separators, biosafety cabinets (BSC), chromatographic system, filling/ capping machines, autoclaves, balances, laboratory Equipment (ie. HPLC, UPLCs, UVVis and pH meters), Single Use technology, Sterilization Equipment (Steam & VHP), Temperature Controlled Units (Cold Rooms, 2-8 C, -80 C, LN2 Freezers, Incubators).
• Use temperature mapping tools including E-Val ProNalSuite/ Kaye Systems, particle counters, manometers, tachometer, RTD’s at minimum.
• Work independently with minimum guidance from Sr. Validation Engineers-Specialists /Validation Manager, planning and organizing validation activities amongst cross functional groups and capably providing and maintaining status updates for validation activities related to day-to-day operations or project work.
• 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 Final Reports, Risk Assessments, Requirements Traceability Matrix ensuring documents meet regulatory and procedural requirements.
• Review all FUSE System Delivery Life Cycle (SDLC) deliverables, provide constructive feedback, and ensure that the deliverables adhere to associated Standard Operating Procedures (SOPs).
• Review. Update SOPs, forms, templates, documentation, and files.
• Work with ISPE Baseline 5, Vol. 2 GMP, GDP, GLP practices including 21CFR Part11 & Part21 O, 50, 56, 58, EU Annex 11, ICH (IND, NDA), USP, ASME and ISPE guidelines– Commissioning and Qualification and FDA industry regulations.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Number of Employees: 501-1,000 employees