Validation Engineer III
About The Position
Validation Engineer III for FUJIFILM Diosynth Biotechnologies Texas, LLC, located in College Station, TX. 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.
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
- 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.
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What This Job Offers
Job Type
Full-time
Career Level
Mid Level
Number of Employees
501-1,000 employees
