FUJIFILM Diosynth Biotechnologies Texas, LLC

Validation Engineer III

College Station, TX

Job Duties: Work in biotechnology industry providing and maintaining status updates for validation activities related to day-to-day operations or project work. Plan and organize validation activities amongst cross functional groups. Generate, obtain approvals, and execute validation deliverables for FUSE systems and relevant infrastructure, including Validation Plans, System Impact Assessments, User Requirements Specification, Risk Assessments, Installation/Operational Qualifications and Performance Qualifications (as applicable) and Validation Final Reports, ensuring documents meet regulatory and procedural requirements. Organize validation activities amongst cross functional groups. Review all FUSE System Delivery Life Cycle (SDLC) deliverables and ensure that the deliverables adhere to associated Standard Operating Procedures (SOPs). Update SOPs, forms, templates, documentation, and files. Execute validation protocols, deviations, and validation summary reports. Utilize Validation Life Cycle Concept. Apply single use technology. Utilize FUSE systems including Clean Room Facilities, Clean Room Utilities , Smoke studies, Sterilization with Steam / VHP. Lab Equipment (ie. HPLC, UPLCs, UVVis and pH meters. Utilize temperatures mapping tools including E-Val Pro/ValSuite/ Kaye System. Employ GMP , GDP, GLP practices including 21CFR Part11 & Part210, 50, 56, 58,EU Annex 11, ICH (IND, NDA), USP ,ASME and ISPE guidelines.

Requirements: Bachelor’s Degree in Information Systems Security, Biotechnology, Pharmaceutical Science, or related field and five (5) years of experience in position offered or related position including five (5) years of  validation experience in a pharmaceutical, biotechnology, or related industry executing validation protocols, deviations, and validation summary reports; utilizing Validation Life Cycle Concept; applying single use technology; utilizing FUSE systems including Clean Room Facilities, Clean Room Utilities , Smoke studies, Sterilization with Steam / VHP. Lab Equipment (ie. HPLC, UPLCs, UVVis and pH meters; utilizing temperatures mapping tools including E-Val Pro/ValSuite/ Kaye Systems; and employing GMP , GDP, GLP practices including 21CFR Part11 & Part210, 50, 56, 58,EU Annex 11, ICH (IND, NDA), USP ,ASME and ISPE guidelines

OR Master’s Degree in Information Systems Security, Biotechnology, Pharmaceutical Science, or related field and two (2) years of experience in position offered or related position including two (2) years of validation experience in a pharmaceutical, biotechnology, or related industry executing validation protocols, deviations, and validation summary reports; utilizing Validation Life Cycle Concept; applying single use technology; utilizing FUSE systems including Clean Room Facilities, Clean Room Utilities , Smoke studies, Sterilization with Steam / VHP. Lab Equipment (ie. HPLC, UPLCs, UVVis and pH meters; utilizing temperatures mapping tools including E-Val Pro/ValSuite/ Kaye Systems; and employing GMP , GDP, GLP practices including 21CFR Part11 & Part210, 50, 56, 58,EU Annex 11, ICH (IND, NDA), USP ,ASME and ISPE guidelines

* Employer will accept any suitable combination of experience, education or training

Salary: $109,000 - $115,000

To Apply:  Please apply directly at https://www.fujifilm.com/us/en/about/region/careers