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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 Director, Process Validation plays a pivotal role in providing technical leadership and strategic vision within the Manufacturing Science and Technology (MSAT) organization. The role responsibilities encompass leading and overseeing all process validation, including material science aspects, to ensure the robustness, efficacy, and compliance of manufacturing processes. his role requires strategic leadership, technical expertise, and cross-functional collaboration to drive continuous improvement and adherence to regulatory standards. The Director, Process Validation is crucial in enhancing the site’s process validation capability offerings and maintaining competitiveness by making significant contributions to the company’s growth and innovation.
The Senior Upgrade Engineer is responsible for performing upgrades for Fujifilm Healthcare Americas Corporation (HCUS) Medical Informatics (MI) products to all eligible sites. In addition will maintain necessary documents and process information regarding upgrades. Works on 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. Normally receives little instruction on day-to-day work and general instructions on new assignments. Offers mentorship to new incumbents on technical and product knowledge and department operating procedures. To meet the needs of our customers, working outside of normal business hours and holidays is required.
The Quality Assurance (QA) Disposition Manager is responsible for the disposition of both clinical and commercial manufactured products (intermediates and Active Pharmaceutical Ingredients (APIs)) ensuring products are produced and analyzed in accordance with FUJIFILM Biotechnologies procedures and Current Good Manufacturing Practice (CGMP) regulations while making recommendations as needed to release or reject manufactured materials that are manufactured at the site. This role organizes, maintains, and communicates the status of batch disposition details, and partners cross-functionally, including with external stakeholders to meet the dynamic needs of the customers programs.
Summary: 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 Environment, Health & Safety (EHS) Specialist will lead EHS and sustainability programs at the FUJIFILM Irvine Scientific facility, driving improved performance through implementing EHS programs, ensuring KPIs are met and investigating all incidents /near miss. The position will also be responsible to ensure all environmental and compliance requirements for the facility are met. The position is also responsible to lead the safety committee and conduct relevant training for the employees
The Automation Engineer 2, CSV will provide support to the Drug Substance Manufacturing (DSM) facility. This includes preparing validation documentation, contributing to the qualification of Drug Substance Manufacturing (DSM) GxP Automation Computerized Systems, and being a part of Automation on-call support as needed. This role will partner with other departments locally and other sites to align strategies and procedures. This role will be responsible for ensuring that all DSM GxP Automation Computerized Systems are maintained in a validated state throughout their lifecycle with a focus on consistent policy administration. Additionally, there will be involvement in facilitating improvement initiatives and supporting regulatory agency and third-party inspections.
The Regulatory Compliance Manager (Corporate) is a member of the FUJIFILM Holdings America Corporation (“HLUS”) Department reporting to the Corporate Compliance Director. The Compliance Manager will be responsible for managing the day-to-day operations of the company’s compliance programs related to laws and regulations, including healthcare compliance, anti-corruption, antitrust, and anti–money laundering (AML). Under the supervision of the Corporate Compliance Director, this individual will ensure the effectiveness of compliance frameworks, oversee due diligence and monitoring activities, and support the ongoing development of policies, procedures, and training programs to foster a culture of integrity and compliance across the organization.
Commuting distance to Valhalla, NY for this position is preferred.
GENERAL PURPOSE
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.
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.
Summary:
The Finance Business Partner is a pivotal role within the Finance Function, primarily supporting the Associate Director of Financial Planning & Analysis in executing strategic initiatives for the site Finance organization. This position demands a high level of expertise in finance and project management, with a focus on driving efficiency and success in alignment with organizational objectives.
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:
Performs routine experiments for process or research and development engineering and records and reports the results. In addition, this position performs diversified mechanical, electromechanical, chemical or electronic technical duties in fabrication, testing, debugging and documentation. Supports engineering activities such as design, test, check-out, modification, fabrication and assembly of prototype electro mechanical systems, experimental design circuitry, laser/light transmission devices or specialized test equipment. Applications may include electronic circuits, photonics and logic systems. Works from schematics, diagrams, written and verbal descriptions, layouts or defined plans to perform testing, checkout and trouble-shooting functions. Performs operational test and fault isolation on systems and equipment. Assists in determining methods or actions to remedy malfunctions. Assists in the design, construction, test and check-out of test equipment. Uses manufacturing, test, development or diagnostic equipment, including, but not limited to, test programs, oscilloscopes, signal generators and specialized test apparatus.
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 Procurement Manager!
The Role
Reporting directly to the Senior Director of Procurement, this position leads procurement strategy and execution for direct materials (semiconductor-grade chemicals, packaging, and filtration) while also overseeing MRO and indirect purchasing. The Procurement Manager is responsible for supplier risk mitigation, cost savings and avoidance, supplier quality and service performance, and the leadership development of a high-performing team.
The Supply Chain Coordinator 2 develops and maintains integrated production planning and scheduling that encompasses materials to ensure that supply targets are met. This position is responsible for ordering and buying materials as well as tracking production and material consumption in the applicable systems.
The Director of Facilities at Fujifilm Biotechnologies Texas (FLBT) is responsible for overseeing a diverse team of facilities personnel. This role focuses on the operation of buildings, site services, metrology activities, and the maintenance of utilities, equipment, and biotechnology manufacturing facilities. Leadership responsibilities may extend to supervising the Security team. The ideal candidate will ensure the efficient and effective operation of all physical assets and infrastructure, maintaining a safe, functional, and welcoming environment for employees and visitors alike.
Position Summary:
Primary Support Role for the Manufacture of Precision Ink Jet Printheads located in Lebanon, NH.
Manufacturing Engineer: Develops, implements and maintains methods, operation sequence and processes in the manufacture or fabrication of parts, components, sub-assemblies and final assemblies. Interfaces with design engineering in coordinating the release of new products. Estimates manufacturing cost, determines time standards and makes recommendations for tooling and process requirements of new or existing product lines. Maintains records and reporting systems for coordination of manufacturing operations.
The Sr. Manager - Facilities Support Operations under the leadership of the Director of Facilities will be responsible for managing the daily maintenance operations including the CCMS/CMMS operation, the work order lifecycle process, the Planning & Scheduling of Maintenance and Calibration activities, and the MRO inventory across multiple facilities. This position will be responsible for the oversight of the maintenance support operations through strict adherence to Standard Operating Procedures (SOPs) and cGMPs in a Biotechnology Facility. This position will coordinate with other team members, such as manufacturing operators, engineers, maintenance and calibrations technicians, validation, quality, and external suppliers to provide a high level of excellence over the maintenance operational activities of FLBT. Also, this position should ensure that departmental milestones and goals are met in accordance with the approved plans and budgets.
POSITION SUMMARY:
Performs routine experiments for process or research and development engineering and records and reports the results. In addition, this position performs diversified mechanical, electromechanical, chemical or electronic technical duties in fabrication, testing, debugging and documentation. Supports engineering activities such as design, test, check-out, modification, fabrication and assembly of prototype electro mechanical systems, experimental design circuitry, laser/light transmission devices or specialized test equipment. Applications may include electronic circuits, photonics and logic systems. Works from schematics, diagrams, written and verbal descriptions, layouts or defined plans to perform testing, checkout and trouble-shooting functions. Performs operational test and fault isolation on systems and equipment. Assists in determining methods or actions to remedy malfunctions. Assists in the design, construction, test and check-out of test equipment. Uses manufacturing, test, development or diagnostic equipment, including, but not limited to, test programs, oscilloscopes, signal generators and specialized test apparatus.
The Supervisor, Financial Accounting role at FLB is a critical position that oversees the company’s accounting functions, ensuring compliance with generally accepted accounting principles, company policies and financial management practices specific to the contract manufacturing industry. This role demands exceptional organizational abilities, a strong technical accounting background and outstanding communication skills. This role effectively manages multiple projects and assignments with competing deadlines.
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