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. 

The Scientist 1, QC Microbiology, DP & RM, effectively and efficiently manages complex or difficult tasks with expertise within the assigned disciplines. This role initially supports the commissioning activities involved in the construction of a new Biopharmaceutical manufacturing facility and laboratory. Flexibility in job roles and assignments is required.

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 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.

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.

The Engineer / Scientist 2 of Process Analytics provides technology transfer support and technical oversight during manufacturing operations as it relates to process analytics data management systems and trending purposes. This role supports senior team members in all aspects of process analytics, including but not limited to closing deviations, generating master batch records, and data system improvement initiatives.

The Senior Synapse System Administrator I (SSAT) is primarily responsible for education (internal and external) as it relates to Synapse System Administration. This includes the development of professional-grade training material, innovative training strategies and comprehensive training curriculums. In addition, this role is responsible for assisting with developing, and participating in all system administration training offerings, e.g., Q & A sessions, hosted and on-site courses.

Interaction with Sales, Customer Support, Clinical Applications, Field Service, the end-user, and the Synapse Integration Team is required. The candidate must develop relationships and communication channels to ensure status feedback and cooperation with stakeholders. Finally, the candidate must ensure that all training is executed professionally to ensure customers are well positioned for ownership, and ultimately, success.

The Associate 2, 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 District Manager will report to the Regional Support Manager and be responsible for planning and directing equipment installation and servicing to toner equipment customers based within an assigned territory. Manage day-to-day activities of Field Service Technician (FST), to meet internal and external customer expectations. The District Manager will reinforce Fujifilm’s leadership values by transforming his or her assigned district into a customer focused, proactive operation that will help drive Fujifilm’s business.

The preferred location for this position would be in a major city in Texas. 

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 role as Manufacturing Associate 2 will execute and document manufacturing processing activities within a cGMP environment. This manufacturing facility will be 24/7 operational and the role may require to be flexible with working hours and shift rotation.

As the Engineering Technician, you will work closely with the manufacturing engineers in the setup, building, process optimization, failure analysis, scrap and cost reduction initiatives for manufactured ultrasound systems, transducers and/or accessories. 

This position requires a person who is self-starting, self-motivated, and a problem-solving team player able to work with minimal supervision.  We will rely on their sound judgment, decision-making qualities and forward-thinking to rise to meet the challenges of this important work.

The Internal Event Planner leads the planning and execution of site wide company events both small and large sizes. This role manages end to end planning and execution of events along with managing a wide range of internal- and potentially external relationships and stakeholders. This role as internal event planner is pivotal in creating an engaging environment for all employees. The role requires a people-focused, self-motivated, and collaborative professional who is organized, detail-oriented, able to multitask, and hands-on.

The Assistant Scientist - Process Development is an entry level position for graduates with no prior experience or training. The individual will assist in the development and characterization of customer programs, and technology transfer to the manufacturing and/or Quality control group as appropriate. This individual will be expected to require training on laboratory instrumentation and then use instrumentation to perform elementary lab experiments and document results appropriately.

The Senior Manager, Quality Assurance (QA) Technical provides technical leadership and oversight for QA in a regulated pharmaceutical environment. This role reviews and approving Good Manufacturing Practice (GMP) documentation (e.g., batch records), leads investigations and root cause analyses for deviations, corrective and preventive actions (CAPAs), manages change controls, and ensures compliance with quality and CGMP regulations. This role also supports validation, automation, data integrity, environmental reports and facility reports while collaborating with internal stakeholders and clients on clinical and GMP events.