The Technician 1, Maintenance is responsible for assisting installation, maintenance, and repair of process related systems/equipment. Ensure these systems meet the stringent requirements of pharmaceutical manufacturing. Also responsible for conducting regular inspections and preventive maintenance on process related equipment to ensure equipment is operating efficiently with minimal downtime.

Summary:  The Associate Director (AD) Quality Operations is responsible for QA oversight of cGMP operations and areas at one of the manufacturing facilities, or the Quality Control unit, at FDBT.  This role is expected to lead a value stream such as TBF, FBF, NCTM or Analytical Development under the guidance of the Sr Director Quality Operations, lead the Quality Operations organization to create a strong quality culture of engaged and motivated staff maintaining strong working relationships with internal and external stakeholders.  Direct all QA on-the-floor,...

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.

We are hiring for a Senior Product Service Delivery Manager who will be responsible for the strategic oversight of service delivery for assigned accounts, ensuring overall customer satisfaction and operational excellence. Reporting directly to the Vice President of Service, this role involves developing and implementing consistent account management processes, focusing on equipment performance, service level attainment, reporting, communication, and meeting structures. The Senior Service Delivery Manager will build and maintain long-term relationships with key stakeholders, ensuring high-quality service delivery that enhances equipment uptime.

We are hiring a QA Auditor. The QA Auditor performs and assists with supplier, distributor, and internal audits. They will be responsible for the coordination and completion of supplier qualifications, re-evaluation and maintaining the electronic supplier files.

The Senior Service Engineer provides technical remote and/or onsite support for the installation and after sales support for FUJIFILM Modality products as, Ultrasound (US) and Mammography Systems, DR and CR systems and Dicom Printers to distributors in Latin America. Responsible for developing training protocols aligned with product service manuals to maximize efficiency of the installation within maximum expected timelines for each. Normally receives minimal instruction in routine work, general instructions on new products or assignments. Determines methods and procedures on new products and provide guidance to other personnel. Responsible for training personnel on how to install equipment...

The Senior Accounting role at FDB 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. The successful candidate will effectively manage multiple projects and assignments with competing deadlines.

The Engineer or Scientist 2 for Process Validation helps ensure that manufacturing processes meet the validation and regulatory requirements for the process to be reproducible under normal operating conditions. This role contributes to the design, execution, and documentation of process validation protocols for equipment, systems, and manufacturing processes. Additionally, this role works with cross-functional teams to help ensure processes are consistently producing high-quality products in a safe and efficient manner.

The Manufacturing Technician I works directly with a range of technologies. Dependent upon assignment, the range of technologies may include any of the following:

This role will perform 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 primary function of this position is to oversee the receiving of scopes, entering information in computer systems, and operating reprocessing and related cleaning equipment. The secondary duties include sorting and prioritizing scopes for inbound inspection and supporting inbound inspections as needed.

The QA Engineer, Pharmaceutical Quality Systems (PQS) Audits & Inspections is responsible for the day-to-day activities of the Pharmaceutical Quality Systems (PQS) team. This role is primarily responsible for coordinating GMP customer audits and regulatory inspections and supporting the Quality Management Review on a local and global level.

The Associate Director (AD), Program Quality is responsible for building and sustaining the quality relationship with partners through transparent and trusting communications, working with Program Management and site SLTs to provide unprecedented delivery. This role is accountable for the quality aspects of customer programs from initial discussions through end of program review/close. The AD, Program Quality works with customers to define quality requirements and governance for all programs, and agrees the process control strategy for the program, ensuring the right level of quality at the right time and demonstrates adaptability by ensuring processes meet regulatory requirements and support...

The Sr. Program Quality Manager is responsible for programs from the point of Quality Agreement signature through program closure. This role ensures Fujifilm Diosynth Biotechnologies, Holly Springs (FDBN) provides services in alignment with our contracted commitment to clients and our company vision/mission (strategy and compliance). This role is the primary client liaison representing FDBN Quality. The Sr. Program Quality Manager handles an average load of 1-3 programs and receives coaching & guidance from the Senior Director, Global Program Quality.

The Senior Engineer or Scientist 2 of Process Analytics serves as the subject matter expert (SME) and provides technology transfer support, technical oversight, and strategic input across laboratory and manufacturing operations. This role leads junior team members through all aspects of process analytic (PA) activities and provides technical guidance and coaching.

The Senior Technical Support Engineer, MI – I (Tier 1) provides highly visible remote technical support across our product lines for HCUS customers. This role focuses on more complex issue and is the second level support across our Synapse products. This engineer is expected be able to resolve most of the cases that are presented to them and responsible for documenting more in-depth

This position is intended to sell Ultrasound imaging systems, options, and service contracts to prospective and existing customers in their assigned territory.

The QA Associate Manager (Operations DSM Upstream) leads and supervises a team of QA professionals responsible for providing day-to-day risk-based QA support of Drug Substance Manufacturing areas and processes in a fast-paced, dynamic startup environment. This role is the primary point of contact for their team and the first-line escalation point in areas of their responsibility. This role requires collaboration with leadership, site-based customers, and global colleagues.

Summary:    The L&D Compliance Specialist III is responsible for the design, development, and delivery of training across the FDBT Organization. They must be able to think creatively when working with Subject Matter Experts across the organization to translate complex ideas into effective training that pertains to trainee’s role and performance. Additionally, they must be...

The Field Service Technician – Level 3 will report to the Regional Support Manager and will be responsible for the service and maintenance of either multiple product lines that the service team supports or a high-speed inkjet product line. This level technician will demonstrate a full working knowledge of the product lines they support including theory of operation as well as the mechanics. This position will require travel throughout the United States.   The preferred location of this position is the Chicagoland...