Sr. Validation Engineer

The Sr. Validation Engineer position at FUJIFILM Biotechnologies Texas involves providing scientific and technical support for product launches, technology transfers, and new technology introduction. The role requires creating validation life cycle documentation, performing validation activities, and leading mid-size validation projects. The successful candidate will have experience in validation engineering, particularly in the areas of FUSE Systems, Single Use technology, and Sterilization with Steam/VHP. The position offers a competitive salary range of $90,000-$127,500 per year.

Requirements

• Master’s degree in Mechanical Engineering or related engineering field
• Three years of experience as a validation engineer or related occupation in validation engineering
• Creating validation protocols, deviations, and validation summary reports
• Utilizing Validation Life Cycle Concept
• Experience with FUSE Systems, including Classified Clean Rooms, Clean Utilities, Sterilization Equipment, Temperature Controlled Units
• Experience 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
• Experience with Single Use technology and Sterilization with Steam/VHP
• Experience with Lab Equipment (ie. HPLC, UPLCs, UVVis and pH meters)
• Experience with temperatures mapping tools including E-Val ProNalSuite/ Kaye Systems
• At least 2 years of experience managing projects
• Experience mentoring or training validations engineers

Benefits

• Flexible work environment
• Comprehensive benefits package
• Competitive salary