The Computer System Validation (CSV) Engineer III, under general direction, will lead the development and approval of validation documentation, risk assessments, work with project teams to determine which elements should be validated and conduct impact assessment of proposed changed to computerized systems.  

We are hiring a Sr. Validations Engineer. The Sr. Validations Engineer will be responsible for performing validation activities related to processes, equipment, test methods, computerized systems, and facilities.

The Manager, QC Lab Support is responsible for leading the Lab Support team and the associated activities to ensure compliant and reliable testing for drug substance and drug product. This role applies broad knowledge and expertise in the areas of biopharmaceutical Quality Control for QC Chemistry, QC Bioassay, QC Microbiology, etc. and operational excellence. This Manager, QC Lab Support provides tactical and strategic direction to the QC Lab Support team and promotes the behaviors and principles that drive continuous improvement throughout the organization.

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 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.  

Summary:  

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...

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.    

The Supervisor, Facilities Maintenance Services under the supervision of the Manager Facility Maintenance Serviceswill 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...

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,...

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...

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 Lead National Support Specialist [NS3], provides an additional level of expertise and experience to the customer service national support specialists team. The Lead NS3 will assist in driving all aspects of customer support related issues, and problems, requiring escalation or high priority of each product including, but not limited to: storage, PACS, VNA, Mobility, 3D Systems, Syncomm and Clinical Information Systems for Radiology to ensure an optimal customer experience and timely resolution to high priority issues.

The Customer Support Technician – Remote Support will be responsible for providing technical support advice and consultation to Fujifilm clients via phone, on-line or other methods.  Travel approximately 15% required for training and development for in house or OTJ opportunities. The Business Innovation Division of FUJIFILM North America Corporation is the...

The Manufacturing Technician III will work directly with a range of technologies. Dependent upon assignment, the range of technologies exposed to will be:

The Manufacturing Technician II work directly with a range of technologies. 

As part of our Global Finance team, you’ll partner with senior leaders, playing a critical role in our growth journey. You will have a comprehensive understanding of all the services offerings of our...

The QA Specialist III, QA Validation, will be responsible for the review and approval of commissioning/qualification/validation protocols, reports, computer automation validation protocols and final reports and discrepancies for Quality Assurance. The QA Compliance Specialist III, QA Validation, will handle all associated responsibilities in compliance with Fujifilm quality policies and site SOPs to ensure regulatory compliance.