22 jobs found in college station

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...

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...

Overview Summary :   The Purchasing & Planning Manager is responsible for the operations of GMP Purchasing and Supply Chain Planning at Fujifilm Texas to ensure that the right materials are available at the right time, in the correct quantity to support GMP production. This role will oversee the materials planning process and direct purchasing while liaising with both internal and external stakeholders on the status of material readiness. The full life cycle of material management will also include the running of the ERP SAP system using MRP. Within SAP, Bill of Material creation, planned demand and conversion to process orders (WIP) will be the responsibility of the Supply Chain teams. The Purchasing & Planning Manager will provide SME over site to these processes as well as managing the Supply Chain teams on a longer strategic planning horizon. External US Essential Functions:   Provide line management,...

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...

Overview Summary :   Under limited supervision of the Sr. Manager, Materials Management, the Supervisor Materials Management is responsible for the assurance of accurate receipt, verification, record keeping, distribution, and shipment of materials and goods. External US Essential Functions: Ensure the accurate receiving, picking and issuance of material in support of manufacturing and quality needs. Review and revise standard operating procedures as required to maintain compliance for the cGMP warehouse and its operations. Perform GMEBA walks to ensure technicians are following all applicable procedures and requirements. Perform system transactions and ensure the timely and accurate order fulfillment, documentation, closure of outstanding issues and effective inventory system. Ensure compliance with safe handling and storage requirements, cGMP/ISO, local & corporate policies, and environmental/other related...

Overview Summary :   The Sr. Process Engineer for DP operations is a mid-level position in the manufacturing department focused to the support of the drug product operations for the Bio Manufacturing Facilities in College Station, Texas.  The manufacturing of drug product employs Filling Isolator Technology for the aseptic filling for multiples projects. The department also oversee the visual inspection process and collaborates with multiples departments to have a final DP unit, in syringes or vial presentation, complying with the quality and client standards. As a CDMO, customer liaison is a vital part of our business and the MFG Process Engineering act as the point of contact for our customers during manufacturing execution and projects.  This position will report directly to the area Manager, DP operations, but may also have a functional reporting relationship to a senior colleague on a project-to-project basis. The Sr Process Engineering may also...

Overview Summary :   The Process Engineer II- DP Manufacturing is an integral part of the Drug Product Manufacturing Operations department, located in College Station, Texas.  This position will report directly to the Manager, DP Manufacturing. Works independently, and with colleagues, to provide expertise and assistance in the drug product operations, including and not limited to support a flawless process execution, assisting in the writing, reviewing and approvals of change controls, deviations and CAPAS. The Engineering will be responsible to keep and maintain all equipment of the area in the operation and compliance state. The position will focus on the resolution, improvements and enhancements of current operations which employs, Filling Isolator Technology for the aseptic filling for multiples projects. This role will also support the visual inspection process and collaborates with multiples departments to have a final DP unit, in syringes or vial...

Overview Summary :   The Information Technology Quality Engineer serves as the IT Administrator for Quality and/or Laboratory Information Systems. External US Essential Functions:   Maintain and configure System Databases and Application Servers Optimize system configurations to maximize performance and ensure availability Participate in planning and implementation of system changes and upgrades Perform periodic maintenance and systems review, including security roles, performance, and data integrity Maintain close collaboration with Quality departments, including business system owners Develop and maintain system documentation Support internal and third-party inspections and audits (FDA, EMA, Clients, etc.) Troubleshoot and resolve questions/problems with assigned applications Resolves and/or coordinates the resolution of technical issues with assigned applications Create documentation for assigned...

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...

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...

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...

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...

Overview Summary :   The Process Engineer, under the supervision of the Director of Engineering, will be responsible for performing engineering activities, new equipment/systems installation, new products introduction support, infrastructure assessments, troubleshooting support and technical expertise for process equipment and site utilities on behalf of the different facilities at Fujifilm Diosynth Biotechnology Texas (FDBT). Equipment support includes bioreactors, incubators, filtration skids, chromatography skids, centrifuge, autoclaves, freezers, refrigerators, walk-in cold rooms, QC/PD lab equipment, air cooled chillers, air compressors and dryers, air handling units, MCRs, MBUs, steam/water boilers, water purification and distillation units, wastewater treatment systems, among others. This position will work closely with facilities, manufacturing resources, CAPEX team, validation, QA/QC and contractors to perform projects implementation and to help maintain...

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,...

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...

Overview Summary :   The Project Engineer, under the supervision of the Director of Engineering, will be responsible for leading, preparing, coordinating and monitoring the implementation of the assigned engineering projects including the development of any specifications and infrastructure requirements, discussion with A&E firms, project documentation review, contractors and/or vendor coordination, field progress inspection and project closeout documentation on behalf of the different facilities at Fujifilm Diosynth Biotechnology Texas (FDBT). Assigned projects may be related to new product introductions, local capital projects and/or strategic projects as dictated by the business needs. This position will work closely with facilities, manufacturing resources, CAPEX team, validation, QA/QC, contractors and other functional areas to execute and document the projects Change Controls procedures as the main system for documenting changes to the facility, utility...

Job Description Position Purpose: Associates in Freight/Receiving positions ensure the store is stocked and ready for business every day. They load and unload trucks, move material from the receiving area throughout the store, may operate forklifts and may perform critical functions for maintaining proper on-hands and pricing for our customers. Direct customer interaction is frequently required for some positions and excellent customer service skills are required. The Freight/Receiving positions may include Freight Team Associate, Freight Team Lead, Receiving Associate and Receiving Support. Pay Rate: -

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...

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...

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,...