Summary:  The Computer System Validation (CSV) Engineer II, under general direction, will be responsible for drafting and executing validation protocols for computer systems, process control systems, as well as preparing validation final reports and all applicable lifecycle documentation.

Summary:  The Computer System Validation (CSV) Engineer II, under general direction, will be responsible for drafting and executing validation protocols for computer systems, process control systems, as well as preparing validation final reports and all applicable lifecycle documentation.

Summary:  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.

Summary:  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.

The Associate 3, EHS is responsible for supporting the development and execution of Environmental, Health, Safety and Sustainability programs. This includes compliance with applicable regulations (Federal, State, Local), codes and standards. As a single point of contact, this position will represent EHS and collaborate with assigned functional operations areas to instill a world class culture of EHS. Additional responsibilities include support of EHS engagement programs (EHS observations, GEMBA), training, audits, inspections, investigations, and collaboration with EHS personnel across the organization.

The Internal Communications Lead provides communication support and direction for strategic initiatives and operational topics. This position supports and maintains FDB’s global standards and develops editorial and video content for intranet, publications newsletters, e-boards, presentations and other internal communication channels. This role works closely with members of the FUJIFILM Biotechnologies Communications Team and supports communications for both the Holly Springs and Morrisville locations.

The Quality Control Chemistry Supervisor, under general supervision, will be responsible for planning, organizing, directing, and evaluating routine activities of the QC Chemistry staff as well as coordinating the installation and qualification of new analytical equipment in support of GMP release and stability testing.  The Chemistry Supervisor will lead tech transfer activities of qualified analytical methods from a designated donor laboratory.  The Chemistry Supervisor will play a pivotal role in selecting qualified personnel to staff the QC chemistry laboratory.  

Territory Manager - Sacramento, CA/Las Vegas, NV - 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 Sacramento, CA or Las Vegas, NV areas.

The Process Engineer 3 provides engineering guidance to support capital projects, technology transfer, and manufacturing operations. This will ensure compliance with all safety, regulatory, and engineering requirements. This role will adhere to product and customer requirements, and work towards optimizing plant efficiency and profitability.

We have opportunities for Manufacturing Associates at several levels within our Drug Substance production teams who are willing and able to work on a DAY SHIFT (Approximately 6:00AM-6:00PM).

These roles will execute manufacturing processing steps and associated activities when operational. You will also participate in operational readiness projects and commissioning/qualification projects. Our brand-new facility will be 24/7 operational and our manufacturing teams work 12-hour shifts on a 2-2-3 calendar rotation.

*** Please note that this posting represents multiple openings within our manufacturing organization  *** 

We have opportunities for Manufacturing Associates at several levels within our Drug Substance production teams who are willing and able to work on a NIGHT SHIFT (Approximately 6:00PM-6:00AM).

These roles will execute manufacturing processing steps and associated activities when operational. You will also participate in operational readiness projects and commissioning/qualification projects. Our brand-new facility will be 24/7 operational and our manufacturing teams work 12-hour shifts on a 2-2-3 calendar rotation.

*** Please note that this posting represents multiple openings within our manufacturing organization  *** 

The Technician 2, HVAC/Refrigeration is responsible for the installation, maintenance, and repair of the heating, ventilation, air conditioning, and refrigeration systems/equipment. This role ensures these systems meet the stringent requirements of pharmaceutical manufacturing and storage environments. Additionally, this role is responsible for conducting regular inspections and preventative maintenance on HVAC/R systems to ensure they are operating within the required specifications.

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

The Field Service Technician – Toner Production Equipment will be considered a specialist for a product line that the BID service team supports. This level technician will demonstrate a full working knowledge of a product line including theory of operation as well as the mechanics. Will provide solutions to complex problems as well as provide field and/or remote support to technicians.

The preferred location for this position is Houston, TX. 

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:

Lead the engineering engine that powers cutting-edge biomanufacturing. As Senior Director, Engineering & Facilities, you will own the strategy, execution, and performance of site engineering and facilities across automation, process engineering, utilities, CQV, security, and capital projects—ensuring world-class reliability, quality, safety, and compliance.

QVS Engineering is a growing team whose mission is to improve the quality of FFSS products through their life cycle, proactively handling component and module obsolescence while strategically reducing COGS (Cost of Goods Sold). The QVS Electrical Engineer III works with a cross-functional team to resolve complex ultrasound systems’ quality issues, defining and implementing innovative modifications to existing electrical designs to reduce cost while still maintaining high quality, and handling obsolescence of electrical/electronic components. Specific requirements include electronic troubleshooting experience using standard lab equipment on circuit boards, expertise in power supplies/power converters, low power design, electronic component selection, and grounding schemes. Previous experience working with FDA-regulated products is highly desired.

The Document Control Specialist II has depth and specialized knowledge of cGMP documentation.  This position can largely function with minimal or no supervisory oversight for routine duties such as document routing, tracking document review and approval process, assessing document related training requirements and tracking training.  Additionally, the individual who performs this role will have sufficient knowledge and experience to establish and modify comprehensive document control systems which are compliant with cGMP requirements.  They may be assigned duties representing Quality in appropriate situations as defined by their management.