The Manufacturing Technician III will work directly with a range of technologies. Dependent upon assignment, the range of technologies exposed to will be:

The EHS Specialist, under the supervision of the Sr. Manager, Biosafety & EHS, will be responsible for assisting in helping develop various safety and compliance programs at Fujifilm Diosynth Biotechnologies Texas (FDBT). Programs include occupational health and safety, fire safety, emergency response, management of hazardous and other special wastes, industrial hygiene, respiratory protection and environmental programs within the scope of EHS.  

The Manufacturing Technician III will work directly with a range of technologies.

The Senior Automation Engineer 2, MES provides support to Drug Substance Manufacturing (DSM). This includes implementation of changes to the Automation systems, updating design documents, executing testing, troubleshooting events, and being a part of Automation on-call support. This role leads projects and handles complex changes while coordinating with other internal and external groups.

The Sr. Engineer, Supplier Quality, provides supplier oversight to ensure that suppliers of services or materials to Fujifilm Diosynth Biotechnologies are of the highest quality while conforming to pre-established requirements including cGMPs. This role primarily focuses on supplier quality, working with suppliers to maintain supplier approvals. Initially, this position will be key to the establishing the Supplier Quality System including but not limited to SOP and Specification development, Quality Agreements, Risk Assessments, Supplier Auditing and Supplier Change Notifications. The ability to effectively collaborate, influence, and coordinate amongst suppliers and team...

This position reports to the Process Engineering Manager, Upstream in support of the Process Equipment team. The initial assignment is to assume the Responsible Engineer role for Media Prep unit operations. As the site moves into commercial operations circa 2025, this position is planned to continue as primary support for Media Prep unit operations, with secondary responsibility expanding to cover additional Upstream unit operations includes supporting commercial operations, technology transfers, and small capital...

Join us! FDB is advancing tomorrow’s medicine, impassioning employees to chase the impossible and continually expand their potential. We are a company of emboldened goal seekers – driven by an innate desire to better ourselves, our families, our workplace, our company, our community, and the world at large.  The Associate Director of QC Microbiology will provide strategic, technical, and operational leadership for QC Microbiology related activities. The individual will proactively identify and implement industry standard methodologies for Quality Control Microbiology Laboratories. Such efforts are related to rapid microbiological methods, media...

FUJIFILM Diosynth Biotechnologies Global Alliance Management (GAM) team, Key Account Director will support the SVP, Large Scale Commercial in development, maintenance and execution of strategies to strengthen existing relationships and foster new relationships with key accounts to support the continued growth of FUJIFILM Diosynth Biotechnologies across the US and EUROPE.    As a Key Account Director, you are responsible for a number of key accounts and driving the strategy and execution of the relationship development...

The Engineer II functions within a team based organization to actively address complex cGMP manufacturing issues.  The individual is responsible for analyzing process technologies in support of new project proposals and assist in the technical transfer into the manufacturing group.   This individual must work in a collaborative manner coordinating the transfer of biological drug processes from process development (internal or client) groups in a CMO environment.

The Quality Assurance (QA) Manager, QA Validation, will be responsible for the review and approval of commissioning/qualification/validation protocols, reports, and discrepancies.  The Manager will handle all associated responsibilities in compliance with FUJIFILM Diosynth Biotechnologies quality policies and site SOPs to ensure regulatory compliance.    Reports to       ...

The QA 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.  

The Quality Assurance (QA) Specialist II, QA Validation, under general direction, will be responsible for review and/or approval of basic and technical documentation; Drafting and reviewing of internal Quality policies and procedures; Assisting in and performing product related activities; Assisting in and performing Quality audit functions; Identifying process and Quality System improvements; Acting as a QA liaison internally.  

The Manufacturing Compliance Coordinator II assists with the tracking, coordination, and closure of Manufacturing CAPAs, change controls and deviations, and assists in supporting the timely release and disposition of batches and other post-execution activities.  

The Senior IT Engineer 2, CSV is the Subject Matter Expert (SME) and leads tasks associated with Computer System Validation (CSV). This role provides input and determine action items on all GxP Manufacturing and IT Computerized Systems as well as prepares validation documentation, maintains a validated state, with a focus on consistent policy administration. Additionally, this role works closely with other workstreams at FDBN and IT departments at other locations to align strategies and procedures. This role facilitates improvement initiatives, supports regulatory agency, and...

The Specialist QA, Compliance supports the Cellular Therapy GMP quality program. This individual is responsible for the management of the Internal Quality Audit Program and facilitates Client Audits and supports Regulatory Agency Inspections. Acts as business process owner (BPO) for the Audits and Inspections process and Risk Management Process.

The Manufacturing Technician IV will work directly with a range of technologies. The Technician IV level provides an opportunity to stay on the technical track, or work towards a supervisory path. Dependent upon assignment, the range of technologies may include any of the following:

The Manufacturing Readiness Coordinator II assists the Manufacturing team to ensure right-first-time execution on the GMP manufacturing floor and on time starts by coordinating and delivering readiness milestones. 

The Director Quality Operations is responsible for QA oversight of CGMP manufacturing operations and areas at one of our manufacturing facilities at FDBT. Lead the Quality Operations organization to create a strong quality culture of engaged and motivated staff maintaining strong working relationships with internal and external stakeholders.  Direct all QA on-the-floor (QAOTF), batch record review (BRR), and product disposition activities including QA review and approval of any associated deviations, CAPAs, and change controls to meet established targets for right first time execution and on-time delivery.  Ensure products are manufactured to meet all CGMP regulatory...

The Quality Control Supervisor, Microbiology under general direction, will be required to plan, organize, direct and evaluate the routine activities of the Quality Control staff and laboratory functions to ensure the safety and reliability of products produced in compliance with The Company Quality and various regulatory requirements. Candidates for this position must have experience in Microbiology and Environmental Monitoring (EM) in a regulated pharmaceutical setting.  Strong candidates will have a working knowledge of additional QC functions in a regulated pharmaceutical setting.

The Commercial Development Director, (internally known as Commercial Development Manager) will be responsible for business development activities and to identify, manage the initial qualification, and close through the signing of contracts for new business, concentrating on Biologics.