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We are hiring a Research Scientist – Formulation and Lyophilization. The Research Scientist – Formulation and Lyophilization will be responsible for leading formulation development studies to improve solubility, stability, and bioactivity of recombinant cytokines and growth factors, design and execute lyophilization cycles with a focus on reducing moisture content, improving cake appearance, and maintaining activity. They will evaluate excipients and delivery system compatibility for liquid and lyophilized formats (vials, bags, etc.), and provide scientific guidance to junior team members and support troubleshooting of formulation-related challenges.
This role will perform manufacturing support activities to ensure compliant and reliable production. This manufacturing facility is 24/7 operational and the role may require to be flexible with working hours.
Fujifilm Diosynth Biotechnologies in Holly Springs, NC is hosting our second Manufacturing Hiring Event this Summer - INVITE ONLY.
These roles will execute manufacturing processing steps and associated activities when operational. You will also participate in operational readiness projects and commissioning/qualification projects. Our brand-new facility will be 24/7 operational. We are hiring for night-specific roles; however, all roles may requires flexibility with working hours and/or shift.
We operate on a 2-2-3, 12 hour shift schedule and are hiring for NIGHT SHIFT ONLY.
Summary: The Process Engineer II, 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 complex process equipment and site utilities. This position will require involvement in the utilities and production processes to identify and implement process improvements using Change Control procedures as well as perform corrective and preventive actions using the CAPA system. This position will also support P&ID development, maintenance strategies development, SOP’s development and equipment commissioning/qualification activities as required. This position will also lead the identification of equipment of the proper type, size, materials, throughput, physical dimensions, required utilities and URS development for future projects.
The Automation Engineer 3, MES 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 maintaining the Manufacturing Execution System (MES).
The LEAD PROJECT TEAM SUPPORT ENGINEER-MI provides remote technical, applications and system support for HCUS customers and supported business units. This role primarily interacts with FUJI Technical Assistance Center (TAC), FUJI customers and other FUJI business units with the management, execution, and administration of operational, billable, and more in-depth projects and support. Supports complex issues where analysis of situations or data requires an in-depth evaluation of variable factors which may include customer impact, HCUS business priorities and regulatory requirements. Provides to assistance to all connected teams on technical and product knowledge and department operating procedures. To meet the needs of our customers and supported business units, working outside of normal business hours and holidays is required.
The QA Specialist, Drug Substance Manufacturing (DSM) is responsible for partnering in the Quality oversight of DSM project processes. This role provides oversight of validation program execution for these processes and systems to ensure applicable DSM systems and processes are operated/maintained in a validated state throughout their lifecycle, with a focus on consistent policy administration. The QA Specialist, Drug Substance Manufacturing (DSM) ensures QA oversight of day-to-day activities and resolution or mitigation of issues occurring during operation.
The Process Engineer 3 provides engineering guidance to support capital projects, technology transfer, and manufacturing operations. This will ensure compliance with all safety, regulatory, and engineering requirements. This role will adhere to product and customer requirements, and work towards optimizing plant efficiency and profitability.
The Process Engineer 1 will provide engineering guidance to support capital projects, technology transfer, and manufacturing operations. This will ensure compliance with all safety, regulatory, and engineering requirements. This role will adhere to product and customer requirements, and work towards optimizing plant efficiency and profitability.
The Principal IT/OT Infrastructure and Security Architect will lead the creation and maintenance of the IT/OT roadmaps, and joint strategies for the mission critical infrastructure, this will be based on global alignment with all relevant stakeholders. They with drive the cybersecurity capabilities and roadmaps globally across IT and OT and ensure alignment with established standards such as NIST 800-82, ISA/IEC62443, CIS-20, and ISO27001.
The Scientist 1, QC Microbiology (Drug Product & Raw Materials) supports a broad range of microbiological functions for both raw materials and drug product manufacturing support. This role manages multiple assignments of increasing complexity and responsibility within the Quality Control laboratory in support of these two areas. This role follows procedures and has mastery of a wide variety of microbiological methods specific to raw material and drug product manufacturing and supporting data management processes. The Scientist 1, QC Microbiology (DP and RM) effectively and efficiently manages complex or difficult tasks with expertise within the assigned disciplines. This role initially supports the commissioning activities involved in the construction of a new Biopharmaceutical manufacturing facility and laboratory. Flexibility in job roles and assignments are required.
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.
We are hiring for a Maintenance Technician Level 1 role. This position is within the Imaging Division (ID) and provides consumer and commercial photographic products and services. The position is responsible for troubleshooting and repairing all production equipment safely and timely for the manufacturing of Personalized Photo products. The job title Maintenance Technician Level 1 will report to the Maintenance Supervisor in Greenwood, SC.
FNAC-ID Personalized Photo Products Group (PPPG) now makes more than 450 personalized items (such as coffee mugs, posters, framed prints, canvas wall décor and more). PPPG provides a turnkey, back-end service of producing these items for a variety of retail and online customers.
Summary: Reporting to the Director of Engineering, the Sr. Process Engineer at Fujifilm Diosynth Biotechnology Texas (FDBT) oversees engineering activities, including equipment installation and product introduction support, infrastructure assessments, and troubleshooting for process equipment and site utilities. The role involves supporting a range of equipment such as bioreactors, incubators, filtrations systems, and others. The engineer collaborates with various teams—facilities, manufacturing, CAPEX, validation, QA/QC, and contractors—for project implementation and equipment maintenance. Key responsibilities include driving process improvements via Change Control procedures and CAPA systems, supporting P&ID, maintenance strategy, SOP development, and equipment commissioning/qualification. Additionally, they lead equipment selection, sizing, material specification, utility needs, and URS development for future projects.
This position is intended to process all outgoing shipments, incoming purchase orders, incoming goods, schedule and process parts for repair, maintain the order and the neatness of the warehouse, assist in the physical counts of inventory, respond to off-hours emergency parts requests, and perform all other duties as assigned.
The Quality Control Analytical technologies (QCAT) group is seeking a dynamic Senior Scientist to manage the team-based execution of assay protocol driven activities for client programs. The QCAT group is a technologically diverse group that primarily performs formal Tech Transfer, Qualification, Validation and Verification of test methods coming out of the development group and then transitions them into our Quality Control group. This high performing group is the interface between the development and quality groups and is responsible for ensuring long term success of the methods entering into QC.
The successful candidate will focus on creating analytical method protocols and summary reports (TT, qualification, validation and verification). The role will oversee individuals executing protocols, review data, ensure a seamless transition to the QC group in a manner that sets them up for “right first time” and prolonged execution success, troubleshoot issues/spearhead investigations, and work closely with the QA group and client SMEs throughout. The candidate will also be expected to follow cGMP documentation practices and initiate deviations, lab investigations, method revisions and other related activities within the quality system.
The Senior Engineer 1, EHS is responsible for leading the development and execution of Environmental, Health, Safety and Sustainability programs. This includes compliance with applicable regulations (Federal, State, Local), codes and standards. Serves as a subject matter expert (SME) and will collaborate with assigned functional operation 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.
We are hiring a Product Release Coordinator. The Product Release Coordinator will be responsible for ensuring quality of product by performing reviews of batch folder documentation in order to release product. They will create and sign off all Certificate of Analysis and be responsible for returned goods authorization product verification.
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