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The Head of Global Single Use (SU) Validation is responsible for designing, maintaining, and continually improving the validation systems in line with current standards. This Head will oversee all Validation aspects of the Single Use Standard across FDB. They will provide leadership, personnel development and oversite of the Company's validation teams and systems for the standard single use facilities.
Summary: The Manufacturing Readiness Coordinator I assist the Manufacturing team to ensure right-first-time execution on the GMP manufacturing floor and on time starts by coordinating and delivering readiness milestones.
Summary: The Technical Operations – Technical Writer will be responsible for drafting batch records for execution of manufacturing campaigns to support client needs. Additionally, this role will be responsible for the creation and revision of PCL’s, procedures and protocols to support manufacturing activities. This role requires an understanding of GMP production, a strong proficiency in Microsoft Office functions, as well as an active approach to learning the latest best practices across the business.
Summary: The Quality Assurance Compliance Specialist III - QA Validation, will be responsible for the review and approval of commissioning/qualification/validation protocols, reports, computer automation validation protocols and final reports and discrepancies for Quality Assurance. The QA Compliance Specialist III – QA Validation, will handle all associated responsibilities in compliance with Fujifilm quality policies and site SOPs to ensure regulatory compliance.
Summary: The Biotechnology Process Sciences Technician I functions within a team based organization to actively address cGMP manufacturing requirements. The individual’s main responsibility is to obtain documentation for cGMP appropriate materials (raw materials and components), prepare item specifications for these materials and track the completion of the specification paperwork. The individual will also assist with other cGMP pre-production activities such as the selection of cGMP appropriate materials and equipment as directed. This individual must work in a collaborative manner to assist the transfer of biological drug processes from process development (internal or client) groups in a CDMO environment.
Summary: The Quality Assurance (QA) - Compliance Specialist I for Audit & Inspection will be responsible for supporting all associated audit responsibilities in compliance with FUJIFILM Diosynth Biotechnologies quality policies and site SOPs to ensure regulatory compliance, including supporting client audits, regulatory inspections, and conducting internal and supplier audits.
Summary: The Quality Assurance – Sr. Compliance Specialist – Audit and Inspection, will support all associated audit responsibilities in compliance with FUJIFILM Diosynth Biotechnologies quality policies and site SOPs to ensure regulatory compliance.
Summary The Quality Control Cell Biology III will be responsible for assisting in the qualification of test methods for in-process and final products. Be able to work under minimal supervision. Perform advanced assays requiring precise analytical skills and understanding of cell biology and immunology principles.
Summary: The Microbiology Analyst III will be responsible for the QC microbiological aspects of cGMP compliance and testing at the FujiFilm Biotechnologies Diosynth Texas (FDBT) Quality Control Laboratory.
Summary: The Microbiology Analyst II will be responsible for the QC microbiological aspects of cGMP compliance and testing at the FujiFilm Biotechnologies Diosynth Texas (FDBT) Quality Control Laboratory.
Summary: The Microbiology Analyst I will be responsible for assisting the QC microbiological aspects of cGMP compliance and testing at the FujiFilm Biotechnologies Diosynth Texas (FDBT) Quality Control Laboratory.
Summary: Our Automation team in College Station, Texas is expanding and we are looking for Automation Technicians to provide technical and operational support, execution of projects and improvements, installation, operation, maintenance and troubleshooting of FUJIFILM Diosynth Biotechnologies Texas, LLC automation systems to meet organizational goals and objectives. This position will also work closely with other operators, technicians and engineers to maintain complex systems.
Summary: The CAPEX Project Coordinator, under the supervision of the Associate Director of Project Engineering and Capital Projects, will be responsible for the support of capital projects documentation through the management of initiation and close out documents, schedule tracking, and multi-departmental approval routing.
Summary: The Quality Assurance (QA) Specialist of compliance, will be responsible for supporting performance of the Quality Systems group. The Specialist will assist with the tracking and coordination and closure Change Control records.
Summary: The Drug Product Operations Technician I will work directly with the Vanrx SA25 Vial Filling Isolator,. following aseptic techniques and procedures in a cGMP environment.
Summary: The Senior Automation Engineer - Operations provides technical support and accountability for the execution of operational activities that are critical to the success of our business. This position will also work closely with other departments to maintain automated systems and related quality requirements.
Summary: This is an experienced person with in depth and specialized knowledge of cGMP documentation. This position can largely function with minimal or no supervisory oversight for routine duties such as document routing, tracking document review and approval process, assessing document related training requirements and tracking training. Additionally, they have sufficient knowledge and experience to establish and modify comprehensive document control systems which are compliant with cGMP requirements. They may be assigned duties representing Quality in appropriate situations as defined by their management.
Summary The Cell Biology Analyst II will be responsible for participating in the Technology Transfer of established methods into the FujiFilm Biotechnologies Diosynth Texas (FDBT) Quality Control Laboratory.
Summary: The Quality Assurance - Compliance Specialist II - Audit and Inspection will support all associated responsibilities in compliance with FUJIFILM Diosynth Biotechnologies quality policies and site SOPs to ensure regulatory compliance.
Summary: Our Capital Project team in College Station, Texas is expanding and we are looking for a Senior Project Engineer to ensure deliverables for his/her respective projects are well managed and in line with their stakeholders and company expectations. We are looking for a Senior Project Engineer who can help to plan projects and establish the criteria by which project success will be measured. The successful candidate will be responsible for establishing project inspection criteria, coordinating the review of project designs and ensuring the proper implementation of project elements. If you are a detail-oriented professional with over 10 years’ experience in project management and engineering, we encourage you to apply for this position.