FDBT - FUJIFILM Diosynth
  • College Station, TX, United States
May 18, 2022  
Overview Summary :   The Quality Assurance (QA) Specialist Supplier quality will be responsible for supporting the supplier quality program.  The Specialist will assist with ensuring all suppliers of raw materials, consumables, and GMP services are qualified prior to use within the facility. External US Essential Functions: Compliance QA representative to external suppliers Interface and coordinate with sister sites on supplier quality system, harmonization, and joint qualification Maintain approved supplier list Process/track complaints to suppliers Develop and issue weekly and monthly metric reporting on supplier performance Provide audit support when needed Participate in Material Review Board (MRB) review of nonconforming product; recommend disposition and corrective action. New Business Growth Support client due diligence and Quality audits as well as regulatory inspections. Work with Quality...
FDBT - FUJIFILM Diosynth College Station, TX, United States
May 18, 2022  
Overview We are looking for a site senior leadership team member who will join as Head of Product Supply on our journey to establish the largest end-to-end cell culture CDMO facility in North America. As Head of Product Supply, you will be responsible for Drugs Substance Manufacturing, Drug Product & Finished Goods Manufacturing and Supply Chain within the new production facility. You will be responsible for heading up and setting the direction for the manufacturing part of the project. As Head of Product Supply, you will play a major part in setting strategic leadership direction for FDB globally and contribute to new standards within our area by leveraging existing experience within large-scale manufacturing of biologics, medical device assembly, packaging and supply chain management. External US The work we do at FDB has never been more important—and we are looking for talented candidates to join us. We are growing...
FDBT - FUJIFILM Diosynth Holly Springs, NC, United States
May 18, 2022  
Overview Summary :   The Manufacturing Planner leads  the creation and maintenance of the short-term production outlook schedule per S&OP Asset Plan and given operational parameters in manufacuring. The primary ouput of this position is the Master Production Schedule and the Monthly Supply KPI metrics report for FDBT.  The Planner reviews prodcution schedules  for opportunities and adjustments based on inputs from Manufacturing readiness, supply chain and program management.  Clear concise updates on the schedule changes are required, and are tailored to the audience (internal customers such as program managers, Finance, Maintenance, Quality and  Manufacturing). The Manufacturing Planner will gather information from various sources (Manufacturing, Program Management, Tech Ops, Supply Chain) for the creation of schedule templates, active production schedules, trackers, and planning tools to support FDBT Manufacturing.  The Manufacturing Planner should have...
FDBT - FUJIFILM Diosynth College Station, TX, United States
May 18, 2022  
Overview The Manufacturing Specialist is recognized as subject matter expert with regard to cell culture and/or microbial upstream and/or recovery and/or downstream manufacturing operations. Ensures delivery of production execution schedule and adherence to daily and weekly schedule. Represents Manufacturing at meetings and tours of manufacturing facility. Initiates and oversees implementation of operational processes, new technology and modifications to existing technology or operational processes aimed at cost reduction, efficiency improvements, minimization of downtime and quality/safety enhancement. Must be able to identify and communicate improvement opportunities and results. Provides feedback regarding operational and manufacturing process performance. External US The Manufacturing Specialist is recognized as subject matter expert with regard to cell culture and/or microbial upstream and/or recovery and/or...
FDBT - FUJIFILM Diosynth Morrisville, NC, United States
May 18, 2022  
Overview We are looking for a Quality Assurance Lead Engineer, Digital Technologies, who wants to participate in our journey to establish the largest end-to-end cell culture CDMO facility in North America. More importantly, someone who wants to be a part of the largest growth journey that we in FUJIFILM have ever entered. As the QA Lead for Digital Technologies, you will have direct impact on the validation of a fully automated $2 billion Greenfield CDMO facility. In the project phase, your main responsibility as the QA Lead for Digital Technologies will be to drive the Quality oversight for the direction of all GxP Manufacturing and IT Computerized Systems as well as oversight of validation documentation for these systems. You will work closely together with other areas within the project, as well as IT/Automation departments at other sites to align strategies and procedures. Once in operations, you will lead the Quality partnership responsible for ensuring...
FDBT - FUJIFILM Diosynth Holly Springs, NC, United States
May 18, 2022  
Overview Summary :   Under limited supervision of the Sr. Manager, Materials Management, the Materials Specialist II is responsible for the accurate receipt, verification, record keeping, distribution, and shipment of materials and goods. External US Essential Functions: Accurately receive, pick and issue material in support of manufacturing and quality needs. Perform system transactions and ensure the timely and accurate order fulfillment, documentation, closure of outstanding issues and effective inventory system. Receive, inspect, segregate and label incoming materials and ensure accurate inventory level to support manufacturing requirements. Comply with safe handling and storage requirements, cGMP/ISO, local & corporate policies, and environmental/other related regulations. Perform the coordination and monitoring of all inbound and outbound shipments, including the detailed packing and tracking of cold...
FDBT - FUJIFILM Diosynth College Station, TX, United States
May 18, 2022  
Overview The Senior Automation Engineer is a mid-level position in the Automation Engineering department of FDBU. This position will directly report to the Associate Director, Engineering, but may also have a functional reporting relationship to a senior colleague on a project to project basis. External US Senior Automation Engineer is a mid-level position in the Process Automation Engineering group of FDBU.  The primary purpose of this position is to provide field equipment support which includes diagnostics/troubleshooting support for the manufacturing, development, and facilities controls and monitoring systems. Under minimal supervision, the Senior Automation Engineer is responsible for the day to day manufacturing control system operations and troubleshooting. The troubleshooting will include doing wire signal tracing, reading wiring schematics and being able to determined I/O communication failures. In addition...
FDBT - FUJIFILM Diosynth Morrisville, NC, United States
May 18, 2022  
Overview You as the Senior Process equipment engineer will ensure that the process equipment deliverables from Fujifilm and from EPCM provider are timely and in the required quality. You will act as driver of the process equipment activities and must be able to, proactively, facilitate cross organizational interaction with external EPCM providers and use your extensive experience from a similar role in large pharma/biotech projects External US Job Responsibilities Part of the process equipment team throughout the project being the main contact to the EPCM provider Secure on time delivery and in right quality from both Fujifilm and EPCM provider Develop and align plans, and in due time propose mitigations if plans are not met Review PI&Ds and other process design documents Provide input to Detailed Design activities in partnership with the EPCM provider Write URSs and support FAT, CQV, Commissioning, and start-up...
FDBT - FUJIFILM Diosynth Holly Springs, NC, United States
May 18, 2022  
Overview FUJIFILM Diosynth Biotechnologies U.S.A., Inc. is seeking a dynamic individual to fulfill the role of Senior Commercial Process Engineer (CPE) Position, within the Commercial Operations organization. The focus of the Commercial Operations team is to provide technical support to Commercial programs manufactured at FDBU, as well as be the point of contact with the client for the manufacturing department. The successful candidate must have a background in Biotherapeutic Manufacturing, with a proven ability to work independently and collaboratively to achieve optimized strategies, and execute programs with the ultimate goal of delivering products that transform the lives of patients. The CPE will provide oversight for the technical execution, standardization and monitoring of commercial product(s), as well as drive continuous improvement around production, compliance and safety. The CPE will be the technical subject matter expert for core manufacturing...
FDBT - FUJIFILM Diosynth Morrisville, NC, United States
May 18, 2022  
Overview Summary :   The Engineer I 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. External US Essential Functions:  Assists in applying scientific and cGMP manufacturing expertise to address issues in the technology transfer and implementation of client specified manufacturing processes for biologics including viral based products and vaccines. Serves on cross-functional technology transfer teams that include client technical staff and internal process development and manufacturing teams. Assists in the identification...
FDBT - FUJIFILM Diosynth College Station, TX, United States
May 18, 2022  
Overview Summary :   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. External US Essential Functions:  Applies scientific and cGMP manufacturing expertise to address issues in the technology transfer and implementation of client specified manufacturing processes for biologics including viral based products and vaccines. Lead multiple overlapping cross-functional technology transfer teams that include client technical staff and internal process development and manufacturing teams. Identification of...
FDBT - FUJIFILM Diosynth College Station, TX, United States
May 18, 2022  
Overview Summary :   The Senior Engineer functions independently and productively 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 takes responsibility for 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. External US Essential Functions:  Applies scientific and cGMP manufacturing expertise to research and resolve issues in the technology transfer and implementation of client specified manufacturing processes for biologics including viral based products and vaccines. Leads multiple overlapping cross-functional technology transfer teams that include client technical staff and internal process...
FDBT - FUJIFILM Diosynth College Station, TX, United States
May 18, 2022  
Overview 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. External US Essential Functions: Collaborate with other Engineers and staff to create more efficient methods and maintain profitability Develop the specifications for...
FDBT - FUJIFILM Diosynth College Station, TX, United States
May 18, 2022  
Overview We are looking for a Quality Assurance Lead Engineer, Drug Substance Manufacturing (DSM), who wants to participate in our journey to establish the largest end-to-end cell culture CDMO facility in North America. More importantly, someone who wants to be a part of the largest growth journey that we in FUJIFILM have ever entered. As the QA Lead Engineer DSM, you will have direct impact on the validation of a fully automated $2 billion Greenfield CDMO facility. In the project phase, your main responsibility as the QA Lead for DSM will be to drive the Quality oversight for the direction of all Drug Substance Manufacturing processes, as well as oversight of validation documentation for these processes. You will work closely together with other areas within the project, as well as QA departments at other sites to align strategies and procedures. Once in operations, you will lead the Quality partnership responsible for ensuring that all DSM systems and...
FDBT - FUJIFILM Diosynth Holly Springs, NC, United States
May 18, 2022  
Overview We are searching for a Process Support equipment engineer that will ensure that the cleaning, steaming, and ancillary process equipment deliverables from Fujifilm and from EPCM provider are timely and in the required quality. You will act as driver of the process equipment activities and must be able to, proactively, facilitate cross organizational interaction with external EPCM providers and use your extensive experience from a similar role in large pharma/biotech projects. We are looking for someone with positive energy, entrepreneurship, and courage to empower and inspire others. You will join an organization with focus on growth, you will have a steep learning curve but most essential there is a focus on people first and what you can bring to the table. We have a diverse workplace for people driven to make a difference. External US The work we do at FDB has never been more important—and we are looking for...
FDBT - FUJIFILM Diosynth Holly Springs, NC, United States Full time
May 18, 2022  
Overview Summary :   The Manufacturing Process Engineer I – is an entry-level position in the manufacturing    department in support of the drug product life cycle located at the Texas Bio Manufacturing Facility in College Station, Texas.  This position will report directly to the Sr. Manager DP Manufacturing but may also have a functional reporting relationship to a senior colleague on a project to project basis. Works independently, and with colleagues, to provide expertise and assistance for the design, development, standardization and maintenance of an operational filler machines utilized in the aseptic fill for drug product.  This person would become the subject matter expert on core manufacturing and operational technologies for the manufacturing unit.  Operational biotechnologies include:  Isolators and their use in the single use technology, visual inspection and work under aseptic and clean rooms. This position will also require to aseptically gown,...
FDBT - FUJIFILM Diosynth College Station, TX, United States
May 18, 2022  
Overview Summary :   Our Capital Project team in College Station, Texas is expanding and we are looking for a 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 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 implantation of project elements.  External US Essential Functions:  Collaborate with other Engineers and staff to create more efficient methods and maintain profitability. Develop the specifications for equipment, infrastructure and systems that are required for each project. Create/maintain the frame work used to develop and monitor project metrics and manage the...
FDBT - FUJIFILM Diosynth College Station, TX, United States
May 18, 2022  
Overview Summary : The Sr. Manufacturing Process Engineer is a mid-level position in the Manufacturing Technology Operations department in support of either the SATURN mAb or Gene Therapy manufacturing facilities located at the Texas BioManufacturing Facility – 100 (TBF – 100) or the Flexible Biomanufacturing Facility - 200 (FBF-200) respectively in College Station, Texas.  The SATURN Platform utilizes entirely single use technology and is a multi-stream, multi-product facility that manufactures clinical and commercial products. The Gene Therapy operations at FBF-200 also utilizes single use technology in support of COVID-19 vaccine candidate manufacturing. As a CDMO, customer liaison is a vital part of our business and the Technical Operations team act as the point of contact for our customers during manufacturing execution.  This position will report directly to the Manager, Technical Operations, but may also have a functional reporting relationship to a...
FDBT - FUJIFILM Diosynth College Station, TX, United States
May 18, 2022  
Overview Summary :  The Manufacturing Process Engineer I position is an integral part of the Manufacturing Technical Operations department, supporting Gene Therapy manufacturing at the National Center for Therapeutics Manufacturing (NCTM) and the Flexible BioManufacturing Facility (FBF200), located in College Station, Texas.  This position will report directly to the Manager of Technical Operations, Gene Therapy Manufacturing. Works independently, and with colleagues, to provide expertise and assistance for the design, development, standardization and maintenance of an operational biotechnology utilized in the manufacture of a variety of gene therapy, protein, and other types of drug substances.  This person would become the subject matter expert on core manufacturing and operational technologies for the manufacturing unit.  Operational biotechnologies include:  Isolators and biosafety cabinets and their use in cell propagation, Cell Culture/Single Use...
FDBT - FUJIFILM Diosynth College Station, TX, United States
May 18, 2022  
Overview Summary :   The Supply Chain Planner is responsible for the planning and execution of materials in support of FDBT GMP projects as per the S&OP asset plan via the site ERP/ SAP system. The Supply Chain Planner will convert the requirements ofthe Process Consumable List after handoff of the required materials and catalog numbers from Process Science.  The Supply Chain Planner will create the Bill of Materials, Material Masters and Project Recipes in SAP.  In order to create Work in Progress (WIP), The Supply Chain Planner will via SAP, convert planned orders into process orders for material picking in the GMP warehouses. The Planner is required to have the right materials, released and available at the correct time to the correct specification to support the Master Schedule. Materials planning will be conducted via SAP following MRP planning principles. The Supply Chain Planner will work with the Process Development, Process Science,...
FDBT - FUJIFILM Diosynth College Station, TX, United States