About This Role

The QC Sr. Specialist 1, Instrumentation works independently to perform routine operations, continuous improvement, and life-cycle management of the QC analytical instrumentation program. This role ensures compliance of QC analytical instrumentation with Data Integrity standards in accordance with regulatory guidelines and company policies and procedures. This role ensures the performance of routine maintenance, completing periodic reviews of  QC analytical instrumentation to confirm compliance and correct deviations and excursions. The role supports stakeholders with issues and guidance related to QC analytical instruments. This role is included in routine on-call and weekend support, as needed.

The Director, Engineering Science plays a pivotal role in providing technical leadership and strategic vision within the Manufacturing Science and Technology (MSAT) of the organization. This role assesses and designs processes to integrate new equipment, optimize facilities, and enhance operational capabilities. The Director, Engineering Science leads engineering studies, drives improvements in Drug Substance Manufacturing (DSM), Drug Product and Finished Goods (DPFG), and ensures innovative solutions are implemented effectively. This role is crucial in enhancing site’s process equipment and technology capability offerings and maintaining competitiveness, by making significant contributions to the company’s growth and innovation.

The Manager of Compliance & Support, DP develops and oversees the manufacturing support team within the drug product scope. This position ensures compliance by addressing and closing gaps, authoring departmental standard operating procedures (SOPs), creating master batch records in electronic systems managing the production scheduler, batch record reviewers, manufacturing execution systems associates, and training coordinators. The role also supports shop floor activities for deviations, corrective and preventive actions (CAPAs), and aids in materials management for production operations.

The Manufacturing Specialist 1, DP performs manufacturing support activities to ensure compliant and reliable production. This role may require flexibility with working hours and shift rotation to support a 24/7 manufacturing facility.

The QA Engineer, Learning Management System (LMS) is responsible for collaborating alongside team members in the creation of curriculum, serving as a ComplianceWire Administrator, assisting in the continual development of FUJIFILM Diosynth Biotechnologies' education program. This role adheres to Good Manufacturing Practices (GMP) to ensure compliance with applicable legislation. The QA Engineer, LMS acts as a site ambassador to encourage, motivate, and assist in meeting deliverables and timelines. This role works closely with other Fujifilm Diosynth Biotechnologies sites to gain alignment and efficiency across the network and drives continuous improvements for the area.

The Manager, Training & Documentation for Manufacturing Support is responsible for leading the training and documentation team, focusing on the development, implementation, and oversight of comprehensive digital learning programs. This role enhances employee skills, drives organizational performance, and supports the company's digital transformation initiatives in drug substance manufacturing. The Manager, Training & Documentation designs strategic digital training solutions, develops accurate and user-friendly documentation, assesses training effectiveness, and fosters a culture of continuous learning and innovation.

The Automation Engineer 1, Building Management System (BMS) provides support to the entire facility ensuring efficiency and reliability of the automated systems that monitor and control environmental conditions and utility production. This role supports senior engineers with the implementation of changes to the automation systems, execution of testing and troubleshooting events, and provides on-call support, as needed. Initially, this role supports the expansion project for the facility with the scope evolving as the project progresses. 

The QA Specialist, Operations is responsible for partnering in the Quality oversight of Drug Substance Manufacturing 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, Operations ensures QA oversight of day-to-day activities and resolution or mitigation of issues occurring during operation. 

The Weigh and Dispense Associate position is responsible with assisting and executing in the set-up, and weighing of raw materials, solvents, and solutions used in GMP manufacturing at FDBN. This role will interact with manufacturing personnel in 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 will be responsible for weighing and dispensing in operations, plus duties to deliver goods to manufacturing, as needed.

Additionally, there will be interim responsibilities associated with a large greenfield start-up, including international travel, performing system user acceptance testing, and setting up the dispensary area for GMP operations.

The Tech 1, Instrumentation & Controls (I&C) role is responsible for ensuring the efficiency and operational reliability of the instrumentation and controls that support facility-wide equipment, and facility systems through effective Corrective and Preventive (CAPA) Maintenance and Calibration practices and know-how.

The Production Scheduler, Drug Substance Manufacturing (DSM) is responsible for creating, maintaining, and optimizing daily and long-term production schedules across DSM operations. This role ensures timely production and efficient use of resources while adhering to current Good Manufacturing Practices (cGMP). Acting as a central coordination point, the scheduler partners with other departments (e.g., Manufacturing, Planning, Maintenance, Quality, Supply Chain, Dispensary) to align material availability, equipment capacity, and staffing needs with the production plan.

As an integral part of the Global Operation Finance team, the Financial Planning Lead plays a pivotal role in enhancing FUJIFILM Biotechnology’s financial and operational strategy. We are seeking a highly skilled Financial Planning Lead whose expertise will drive financial performance, support strategic decision-making, and foster cross-departmental collaboration, tools and processes. 

The primary focus of this role is on process improvement and optimization. You will be responsible for identifying and implementing innovative solutions that streamline financial operations. This includes enhancing existing systems and workflows to increase efficiency, accuracy, and compliance.