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The accomplished Senior Corporate Compliance Specialist will support FUJIFILM’s Corporate Compliance Program’s operations to ensure high ethical standards are observed and the compliance program is effective and efficient. The successful candidate will operate independently and with limited management oversight. The position will report to the Compliance Officer.
Who We Are
FUJIFILM Electronic Materials, U.S.A., Inc., is a global leader in chemical solutions which enable the semiconductor industry and the digital universe. We have an exciting opportunity at our Mesa, AZ facility for a LIMS Administrator!
With state-of-the-art manufacturing facilities in the U.S., Europe, Taiwan, China, Korea and Japan, local sales offices throughout the world and on-site applications support, FUJIFILM Electronic Materials supplies the world's top tier semiconductor manufacturers with a broad array of products and services used throughout the semiconductor manufacturing process.
The Role
The LIMS Administrator responsibilities include providing project management services to the laboratories and manufacturing in the areas of LIMS and SAP. They assist in the development and implementation of our existing Labware system, participates in application development, laboratory automation/optimization and supports our quality systems.
The Automation Engineer 3, DSM Upstream 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 supporting the delivery of DeltaV logic for Upstream process areas including Inoculum Lab, Media Preparation, Seed Culture, Large Scale Bioreactors, and Harvest.
The Senior Director, Strategy & Execution will use strong leadership and problem-solving skills to implement/drive the strategic planning and advancement of operational capabilities for the Holly Springs site. This pivotal role is responsible for developing a comprehensive operating system. In this capacity, you will guide both a team of 3-5 direct reports as well as 10+ indirect reports involved in continuous improvement, project management, and communications, inspiring a collaborative and high-performance culture. The Senior Director, Strategy & Execution plays a key role in ensuring site objectives are aligned to deliver the broader Company ambition. You will need to be based onsite daily.
The Sr. Engineer, Quality Assurance is responsible for establishing and maintaining a robust and efficient Technology Transfer program at the Holly Springs, NC site. This position is responsible for ensuring the quality and compliance of initial Technology Transfer (TT) activities and supporting the continuous improvement and ongoing success of the TT lifecycle. This position interacts cross-functionally with Manufacturing, Supply Chain, Quality Control, Process Sciences, Validation, and various Client functions to ensure Quality objectives and initiatives are effectively delivered in a phase compliant manner.
We are hiring a Liquid Packaging Technician. The Liquid Packaging Technician is responsible for Inspecting and labeling application for all filled product, case packaging of all sterile filled products into appropriate boxes, and bottle/vial preparation and staging.
1st Shift (5:00AM - 1:30PM)
This position is intended to oversee all technical aspects of Synapse product implementation, from solution validation phases through product go-live. The Project Engineer (PE) must have well rounded knowledge in all areas of medical informatics - IT infrastructure design and deployment, medical imaging industry expertise, and clinical environment workflow. In addition to technical expertise, PE's are also critical in HCUS's overall goals of delivering industry leading customer satisfaction, requiring excellent communication and verbal skills within project teams and externally with customers.
The Supply Chain Planner 3 role supports the project phase and operations of GMP Purchasing and Supply Chain Planning at FDBN to ensure that the right
materials are available at the right time, in the correct quantity to support process validations and GMP production. This role supports the materials
planning process and direct purchasing while liaising with both internal and external stakeholders on the status of material readiness. This role is
responsible for supporting the planning team and orchestrating associated tasks to start up, while transitioning into commercial operations, including, but
not limited, establishing standard operating procedure, reports, material plans, manage projects and stakeholder relationships. The role collaborates
closely with all stakeholders across the FDB to setup accurate master data for both material and production planning in the SAP ERP system.
The Engineer / Scientist 3, Downstream MSAT will provide tech transfer support and technical oversight for large scale purification activities for Monoclonal antibody production.
The Senior EHS Safety Specialist (internally known as Environmental Health & Safety Manager) will lead safety and environmental programs located in Richmond, VA and support multiple facilities, driving improved safety and environmental performance through thorough and accurate incident reviews, implementing programs to increase safety awareness and compliance, and ensuring safety meetings and training are meaningful and engaging. Provide oversight to ensure proper operation of environmental control system.
Territory Manager - N. Philadelphia - Remote
As a member of our sales team, you will sell portable ultrasound systems in a consultative, professional and high velocity sales environment. This includes creating primary market demand for FUJIFILM Sonosite products by networking, cold calling, and educating users in hospitals and the physician office market on the value of FUJIFILM Sonosite’s hand-carried compact ultrasound systems and tools.
This position requires previous capital medical equipment sales experience.
To best serve the territory, prefer candidates currently located in the North Philadelphia area
This role will lead and execute manufacturing processing steps, associated activities, and assist the supervisor as required. This manufacturing facility will be 24/7 operational and the role may require to be flexible with working hours and shift rotation.
The Associate Manager of Instrumentation & Controls (I&C) ensures the efficiency and operational reliability of the site instruments through an effective calibration process. This role sets the direction and manages the development of the I&C team as the site transitions from construction to operations. Additionally, this role assists with establishing efficient programs designed fit for future operations by utilizing current Good Manufacturing Practice (cGMP) / Good Laboratory Practice (GLP) knowledge, work scheduling, instrument calibration, repair, and troubleshooting. This role also provides day-to-day oversight and development of the I&C team.
Summary: The Sample Management Analyst I, under general direction, will be responsible for performing routine and non-routine support of samples submitted to the Quality Control (QC) Laboratory for evaluation. This position works as part of the Sample Management team to manage the receipt, organization and inventory of samples from manufacturing, clients, other Fujifilm facilities and third parties. The Sample Management Analyst I arrange sample shipments for outsource testing and shipments to Clients or other facilities and controls dispensing of samples for QC testing.
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 Tech 2, Instrumentation & Controls (I&C) is responsible for ensuring the efficiency and operational reliability of the instrumentation and controls that support facility-wide equipment, and facility systems through effective Preventive and Corrective Maintenance and Calibration practices and know-how.
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 document preparation and review, managing project timelines, conducting qualification and validation protocols, and assisting management with training and on-boarding of new staff as needed and in addition to regular work duties and assignments.
This role performs 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.
The QA Specialist III, QA Compliance, will be responsible for the review and approval of commissioning/qualification/Compliance protocols, reports, computer automation Compliance protocols and final reports and discrepancies for Quality Assurance. The QA Compliance Specialist III, QA Compliance, will handle all associated responsibilities in compliance with Fujifilm quality policies and site SOPs to ensure regulatory compliance.
Reports to Manager, QA Compliance
Work Location College Station, TX
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