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The Validation Engineer III, under general direction, will be responsible for drafting and executing validation protocols for Facilities, Utilities, Systems and Equipment (FUSE), as well as preparing validation final reports for the same.
College Station, Texas may be a small, university town, but the lively cultural scene and local amenities make it a great place for families as well as those who want the ease of small-town life and the convenience of living close to the vibrant pulse of big cities. Eighty-seven percent of Texas' population lives within a 180-mile radius, so we are in the center of it all in Texas. And our site is nestled in the hub of innovation, representing a source of pride for the area.
The Validation Engineer III, under general direction, will be responsible for drafting and executing validation protocols for Facilities, Utilities, Systems and Equipment (FUSE), as well as preparing validation final reports for the same.
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 Supervisor may be assigned to work directly with Upstream, Downstream or Solution Preparation Unit Operations. This individual will supervise a team of employees directly or indirectly in these production process units.
The Manufacturing Supervisor may be assigned to work directly with Upstream, Downstream or Buffer Preparation Unit Operations. This individual will supervise a team of employees directly or indirectly in these production process units.
The Senior Automation Engineer 1 will provide 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. This role focuses on leading the Automation scope for delivery of DeltaV logic for CIP & Clean Utilities process areas including Clean-in-Place (CIP), WFI (Water-for-Injection) Generation and Distribution, WPU (Process Water) Generation and Distribution, Clean Steam Generation, and Waste Collection.
The Senior Automation Engineer 1, 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. This role will lead projects and handle complex changes while coordinating with other internal and external groups
The Microbiology III will be responsible for the QC microbiological aspects of cGMP compliance and testing at the FUJIFILM Diosynth Biotechnologies Texas (FDBT) Quality Control Laboratory.
Company Overview:
About FUJIFILM Locally: FUJIFILM Imaging Colorants, Inc. is part of FUJIFILM’s Ink Solutions Group comprised of four companies based in the UK, USA, and India. Fujifilm Imaging Colorants, Inc. has a manufacturing site in New Castle, DE where aqueous dyes, RxD, and inks are made to support the Inkjet digital printing market.
About the Global Business: Celebrating our 90th anniversary in 2024, Japan’s pioneering photographic film maker, FUJIFILM has leveraged its imaging and information technology to become a global presence known for innovation in healthcare, graphic arts, optical devices, highly functional materials, and other high technology products. We use leading-edge, proprietary technologies to provide top-quality products and services that contribute to the advancement of culture, science, technology and industry, as well as improved health and environmental protection in society. Anchored by an open, fair and clear corporate culture and with leading-edge, proprietary technologies, FUJIFILM is determined to remain a leading company by boldly taking up the challenge of developing new products and creating new value.
The Quality Control Lab Technician supports Manufacturing and various departments on site with analytical testing. The Quality Control Lab Technician is responsible for delivering analytical results within all EHS, quality, and corporate guidelines on a right-first-time basis. The position requires the ability to work rotating shifts. Technician works under the general direction of a Quality Control Shift Leader or Chemist. A wide variety of simple to highly complex laboratory tasks are conducted with a consistently high degree of independence. The position requires dependability, versatility, judgement and manipulative skill. The Technician follows all appropriate training programs, complies with all documentation requirements within the department (i.e. SOP’s, analytical logs), and effectively communicates with QC team members, supervision, and other departments. In addition, the Technician will provide direct, frontline responsibility for adherence to Quality Assurance Systems in terms of the assurance test sample program, calibration protocols, SOP’s, control limit monitoring, and all other prescribed quality initiatives.
Must be willing to work a seven-day rotating 12 hour shift schedule which may include holidays
The Senior Compliance Specialist owns all manufacturing CAPAs, change controls and deviations. Leading all manufacturing deviation investigations through to completion. Support all internal and external audits. Work collaboratively with cross functional groups including Quality Assurance to support ‘on-time’ release and disposition of batches and other post-execution activities.
Summary: The Manufacturing Compliance Coordinator I leads 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.
We are hiring for an Accounts Payable Processor who will report to the Accounts Payable Supervisor and be responsible for performing a combination of calculating, posting, verifying, and reconciling duties to obtain primary financial data for use in maintaining accounts payable records. This position requires additional technical/analytical knowledge of internal systems and functions related to maintaining daily operations of critical processes for FUJIFILM Holdings America Corporation, supporting various Fuji companies.
We are hiring for a Production Coordinator to work within the Imaging Division (ID) that provides support for consumer and commercial photographic products and services. The position is responsible for assisting Supervisors and Managers in scheduling, coordinating, and executing work plans and activities of associates engaged in the manufacturing of Personalized Photo products. The position is an hourly, non-exempt role that requires flexibility in scheduling. This means you must be available to work on any day of the week and during any shift, with a rotating schedule that will vary based on the needs of the business. The ideal candidate should be reliable, able to adapt to changes easily, and excel in a fast-paced work environment. The job title Production Coordinator will report to the Production Supervisor II in Greenwood, SC.
FUJIFILM North America Corporation, a marketing subsidiary of FUJIFILM Holdings America Corporation, consists of six operating divisions. The Imaging Division provides consumer and commercial photographic products and services, including silver halide consumables; inkjet consumables; digital printing equipment, along with service and support; personalized photo products fulfillment; film; one-time-use cameras; and the popular INSTAX® line of instant cameras, smartphone printers, instant film, and accessories. The Electronic Imaging Division markets its GFX System and X Series lines of mirrorless digital cameras, lenses, and accessories to provide a variety of content creation solutions for both still and moving imagery. The Optical Devices Division provides optical lenses for the broadcast, cinematography, closed circuit television, videography, and industrial markets, and also markets binoculars and other optical imaging solutions. The Graphic Communication Division utilizes its extensive industry knowledge to develop fully supported traditional and digital print solutions for industries including commercial print, wide format, and packaging with its comprehensive line of digital inkjet presses, production toner printers, and software. The Industrial Products Division delivers new products derived from Fujifilm technologies including data storage tape products, including OEM and FUJIFILM Ultrium LTO cartridges, desalination solutions, microfilters and gas separation membranes. The Non-Destructive Testing Division delivers radiography solutions to ensure high accuracy inspection of transportation infrastructure, and assets within aerospace, and oil and gas industries.
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.
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 Weigh and Dispense Associate 1 is responsible for assisting with and executing the set-up, weighing of raw materials, solvents, and solutions. This role interacts with 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 is responsible for weighing and dispensing in operations, plus duties to deliver goods to manufacturing, as needed. The Weigh and Dispense Associate 1 is required to work shiftwork, including nights and on-call.
The Supervisor, Facilities Maintenance Services under the supervision of the Manager Facility Maintenance Services will be responsible for maintaining, administering and improving the Computerized Calibration & Maintenance Management System (CCMS/CMMS) in support of the Texas operations. Primary responsibilities include managing the daily maintenance operations including the CCMS/CMMS administration, the work order lifecycle process, the Planning & Scheduling of Maintenance and Calibration activities, and the MRO inventory across multiple facilities.
This position with assigned personnel and/or contractors will be responsible for the oversight of the maintenance support operations through strict adherence to Standard Operating Procedures (SOPs) and cGMPs in a Pharmaceutical Manufacturing Facility. This position will interact with other maintenance and technical trades, such as manufacturing operators, engineers, maintenance and calibrations technicians, validation, quality and external suppliers in order to provide a high level of excellence over the maintenance operational activities of FDBT. Also, this position should ensure that departmental milestones and goals are met in accordance to the approved plans and budgets.
The Planner/Scheduler for Calibration under the supervision of the Supervisor for Maintenance Services is responsible for the planning, scheduling and performance of the calibration program including the oversight of the Computerized Calibration & Maintenance Management System (CCMS/CMMS) in support of multiple manufacturing facilities such supporting Texas operations. Primary responsibilities include managing the daily calibration operations such as screening of incoming work orders, identification of job requirements, scheduling of calibration staff. This position will interact with other maintenance and technical trades, such as manufacturing operators, engineers, maintenance technicians, validation, quality and external suppliers in order to provide a high level of excellence over the calibration operational activities of FDBT.
The Associate Planner for Facilities, under the supervision of the Supervisor Maintenance Services, or designated supervisor will be responsible for performing various aspects of Facility Services and coordination of Work order support for the Texas campus. Primary responsibilities include various aspects to support facilities with planning and scheduling equipment for biotech processing equipment. This position will require the use of technical manuals, on-line resources and OEM representatives to maintain the equipment. Strict adherence to Standard Operating Procedures (SOPs), cGMPs and Quality Standards in a Pharmaceutical Manufacturing facility are mandatory.
The Technical Support Engineer, MI – II (Tier II) handles remote technical support across our product lines for HCUS customers. The expectation of the position is to be versed in primary support across our Synapse products, and the ability to support more complex issues. This engineer must be comfortable with making decisions while working on these more complex issues. This role requires a firm grasp of time management and organizational skills. To meet the needs of our customers, working outside normal business hours and on some weekends/holidays is required. In addition to working OT to handle workload and meet required metrics/expectations.
The Manufacturing Technician I works directly with a range of technologies. Dependent upon assignment, the range of technologies may include any of the following:
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