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The Technician 2, HVAC/Refrigeration is responsible for the installation, maintenance, and repair of the heating, ventilation, air conditioning, and refrigeration systems/equipment. This role ensures these systems meet the stringent requirements of pharmaceutical manufacturing and storage environments. Additionally, this role is responsible for conducting regular inspections and preventative maintenance on HVAC/R systems to ensure they are operating within the required specifications.
The Manufacturing Technician III will work directly with a range of technologies. Dependent upon assignment, the range of technologies exposed to will be:
The Automation Engineer 2, Building Management System (BMS) provides support to the entire facility ensuring efficiency and reliability of the automated systems that monitor and control environmental conditions and utility production. This role supports senior engineers with the implementation of changes to the automation systems, execution of testing and troubleshooting events, and provides on-call support, as needed. Initially, this role supports the expansion project for the facility with the scope evolving as the project progresses.
The Automation Engineer 2 provides support to the Drug Substance Manufacturing (DSM) facility. 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. Additionally, this role participates in designing and maintain the Manufacturing Execution System (MES).
This role as manufacturing Associate 4 will execute manufacturing processing steps and associated activities. This position will also support and assist in scheduling daily manufacturing activities for the team. This manufacturing facility will be 24/7 operational and the role may require to be flexible with working hours or shift rotation.
The Field Service Technician – Toner Production Equipment will be considered a specialist for a product line that the BID service team supports. This level technician will demonstrate a full working knowledge of a product line including theory of operation as well as the mechanics. Will provide solutions to complex problems as well as provide field and/or remote support to technicians.
The preferred location for this position is Houston, TX.
The Weigh and Dispense Associate position is responsible with assisting and executing in the set-up, and weighing of raw materials, solvents, and solutions used in GMP manufacturing at FDBN. This role will interact with manufacturing personnel in both Drug Substance and Drug Product teams as well as Warehouse for commercial operations and tech transfer activities required from the Weigh and Dispense operations. This role will be responsible for weighing and dispensing in operations, plus duties to deliver goods to manufacturing, as needed.
The Raw Material Sampler 3 position is responsible for sampling of materials and products at the Holly Springs FDBN large scale manufacturing facility, which produces Drug Substance (DS), Drug Product (DP), and Finished Goods (FG) products. This role works with multiple functions to support operations: Warehouse, Supply Chain, Quality Control (QC), and other customers, as needed. The Raw Material Sampler 3 uses Systems and Applications Production (SAP) Enterprise Resource Planning (ERP) system for inventory management and Laboratory Information Management System (LIMS) for sample management while operating in a good manufacturing practice (GMP) facility with standard operating procedures (SOPs).
The Scientist 1, QC Analytical Development Chemistry supportsthe transfer of analytical Chemistry methods for Technology Transfer (TT) of drug substance
(DS) and drug product (DP) into the Quality Control laboratories of FUJIFILM Biotechnologies, Holly Springs (FLBN). This role ensures Good Manufacturing Practices (GMP) compliant laboratory operations in accordance with regulatory guidelines. The Scientist 1, QC Analytical Development Chemistry authors transfer documents and executes testing as part of transfer for the following analytical methods: HPLC/UPLC chromatography (Protein A/G titer, SEC, PS80, glycans, peptide map); UVA280 and slope spectroscopy; capillary electrophoresis (CE-SDS, imaged capillary isoelectric focusing (icIEF)); general...
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:
QVS Engineering is a growing team whose mission is to improve the quality of FFSS products through their life cycle, proactively handling component and module obsolescence while strategically reducing COGS (Cost of Goods Sold). The QVS Electrical Engineer III works with a cross-functional team to resolve complex ultrasound systems’ quality issues, defining and implementing innovative modifications to existing electrical designs to reduce cost while still maintaining high quality, and handling obsolescence of electrical/electronic components. Specific requirements include electronic troubleshooting experience using standard lab equipment on circuit boards, expertise in...
The Document Control Specialist II has 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, the individual who performs this role will 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.
The QC Analyst is responsible for the key operational aspects of the QC Microbiology laboratory. Incumbent will perform microbial testing of all in -process drug substance, drug product, EM/UM, and raw materials samples. Incumbent will be responsible for all associated activities associated with this testing in accordance with written procedures. This position primarily works under minimal supervision as needed. This position will initially be involved in the commissioning activities involved in the construction of a new Biopharmaceutical manufacturing facility and laboratory. Flexibility in job roles and assignments will be required. This may include writing or assisting with...
The QC Analyst is responsible for the key operational aspects of the QC Microbiology laboratory. Incumbent will perform microbial testing of all in -process drug substance, drug product, EM/UM, and raw materials samples. Incumbent will be responsible for all associated activities associated with this testing in accordance with written procedures. This position primarily works under minimal supervision as needed. This position will initially be involved in the commissioning activities involved in the construction of a new Biopharmaceutical manufacturing facility and laboratory. Flexibility in job roles and assignments will be required. This may include writing or assisting with...
The Engineer / Scientist 2 of Process Analytics provides technology transfer support and technical oversight during manufacturing operations as it relates to process analytics data management systems and trending purposes. This role supports senior team members in all aspects of process analytics, including but not limited to closing deviations, generating master batch records, and data system improvement initiatives.
The Senior Synapse System Administrator I (SSAT) is primarily responsible for education (internal and external) as it relates to Synapse System Administration. This includes the development of professional-grade training material, innovative training strategies and comprehensive training curriculums. In addition, this role is responsible for assisting with developing, and participating in all system administration training offerings, e.g., Q & A sessions, hosted and on-site courses.
Interaction with Sales, Customer Support, Clinical Applications, Field Service, the end-user, and the Synapse...
The Associate 2, EHS is responsible for supporting the development and execution of Environmental, Health, Safety and Sustainability programs. This includes compliance with applicable regulations (Federal, State, Local), codes and standards. As a single point of contact, this position will represent EHS and collaborate with assigned functional operations areas to instill a world class culture of EHS. Additional responsibilities include support of EHS engagement programs (EHS observations, GEMBA), training, audits, inspections, investigations, and collaboration with EHS personnel across the organization.
The District Manager will report to the Regional Support Manager and be responsible for planning and directing equipment installation and servicing to toner equipment customers based within an assigned territory. Manage day-to-day activities of Field Service Technician (FST), to meet internal and external customer expectations. The District Manager will reinforce Fujifilm’s leadership values by transforming his or her assigned district into a customer focused, proactive operation that will help drive Fujifilm’s business.
The...
The Production Technician 3 executes manufacturing processing steps and associated activities while maintaining strict adherence to Current Good Manufacturing Practice (CGMP), quality and regulatory standards. Flexibility with working hours and shift rotation is essential to effectively support the 24/7 manufacturing facility.
The Sr. Supply Chain Material Systems Coordinator will leverage SME-level SAP expertise to manage inventory control and ensure accurate and efficient data entry. This role is critical in maintaining stock levels and transactional order accuracy, supporting operational effectiveness, and adhering to quality standards. The coordinator will oversee communications between the MES system (PAS-X) and SAP, performing routine tasks and resolutions to maintain inventory accuracy.