We have an exciting opportunity at our Mesa, Arizona facility for a Material Handler Technician!  The role of the Material Handler Technician is to support CMP Manufacturing with the necessary raw materials/supplies to sustain HVM operations without interruption.

Readiness Engineer I is an entry to mid-level position in the Manufacturing department. This position will report directly to the US/DS Readiness Lead but may also have a functional reporting relationship with a senior colleague on a project-to-project basis.

This role works independently and with colleagues to provide expertise and assistance for the design, development, standardization, and maintenance of operational biotechnology utilized in the manufacture of proteins and drug substances. This person would be the liaison between the technical transfer team and Manufacturing and will provide input into the Processes being transferred to Manufacturing to ensure that the Process Designed is executable in Manufacturing. Additionally, this engineer may be assigned to revise records between runs or batch campaigns, prepare study plans and prepare and execute engineering test plans, as needed.

The Senior Engineer functions independently and productively within a team based organization to actively address complex cGMP manufacturing issues.  The individual is responsible for analyzing process technologies in support of new project proposals and takes responsibility for the technical transfer into the manufacturing group for Clinical and/or Commercial. This individual must work in a collaborative manner coordinating the transfer of biological drug processes from process development (internal or client) groups in a CMO environment. 

As the Manager, Data Enablement & Analytics, you will understand that data is the key to the future success of the company, and this role is essential to ensuring we have reliable data insights to inform business decisions at every level.  This position will be responsible for developing a strategy to ensure our processes and systems are set up to create the data insights the business is looking for.  The key to success in this role is creating a data environment that produces reliable insights in every area of the business. 

The Senior Director Quality Operations is responsible for QA oversight of CGMP manufacturing operations and areas at one of our manufacturing facilities at FDBT. 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 (QAOTF), batch record review (BRR), and product disposition activities including QA review and approval of any associated deviations, CAPAs, and change controls to meet established targets for right first time execution and on-time delivery.  Ensure products are manufactured to meet all CGMP regulatory requirements for phase-appropriate clinical and commercial bulk drug substance and drug product manufacture.

This will be up to a 3-month paid internship (hourly rate range $25-$30/hour, commensurate with experience) focused on characterizing, developing, and optimizing chemical processes. This is a temporary position employed by SwipeJobs, working on site at Fujifilm Dimatix.

• KNOWLEDGE: Learns to use professional concepts. Applies company policies and procedures to resolve routine issues.
• JOB COMPLEXITY: Works on problems of limited scope. Follows standard practices and procedures in analyzing situations or data from which answers can be readily obtained. Builds stable working relationships internally.
• SUPERVISION: Normally receives detailed instructions on all work.
• EXPERIENCE: Typically requires no previous professional experience

The Industrial Engineering Intern position will be up to a 3-month paid internship, hourly rate range $25-$30/hour, commensurate with experience. Industrial Engineering Intern will be assisting the Continuous Improvement team which may include any of the following activities: Measuring and analyzing work practices such as labor and machine times, identifying productivity improvement opportunities, layout validating and planning, designing training checklists and tests, updating procedural documents, auditing existing processes, participating in 5S activities, and analyzing capital equipment utilization.

• KNOWLEDGE: Learns to use professional concepts. Applies company policies and procedures to resolve routine issues.
• JOB COMPLEXITY: Works on problems of limited scope. Follows standard practices and procedures in analyzing situations or data from which answers can be readily obtained. Builds stable working relationships internally.
• SUPERVISION: Normally receives detailed instructions on all work.
• EXPERIENCE: Typically requires no previous professional experience

This is a temporary position employed by SwipeJobs, working on site at Fujifilm Dimatix. 

We seek a MEMS Development Engineering intern who is actively enrolled as a full-time student pursuing an Undergraduate or Graduate degree in Material Science, Chemistry, Chem-, Bio- or Nano-Engineering, or a related field, at a four-year university. This intern will work with a cross-functional team that interacts across different areas of device fabrication to develop next generation products. This will be up to a 3-month paid internship, hourly rate range $25-$35/hour, commensurate with experience.  This is a temporary position employed by SwipeJobs, working on site at Fujifilm Dimatix.

The Supervisor Quality Assurance Compliance – External Audit will support all associated responsibilities in compliance with FUJIFILM Diosynth Biotechnologies quality policies and site SOPs to ensure regulatory compliance. The teams are broken up into two core functional groups: One will be overseeing the successful delivery of internal audits and the other one will be overseeing the successful delivery of external audits. You will be assigned to supervise one group or the other but may be asked to provide support to the whole Audit & Inspection group on occasion.

The Zone Pulmonary Sales Specialist is a key member of the Fujifilm Endoscopy sales team that is responsible for driving awareness, market share, and revenue growth across Fujifilm's Pulmonary product line. This includes flexible scopes, Endobronchial Ultrasound (EBUS), and all other pulmonary franchise offerings. The role is accountable for business development, strategic partnerships with Key Opinion Leaders (KOLs), and collaboration with the existing Fujifilm Endoscopy sales and clinical specialist teams to ensure successful demonstrations and customer satisfaction. Reporting directly to the Regional Sales Leader, the Zone Pulmonary Sales Specialist plays a pivotal role in expanding Fujifilm's presence in the pulmonary space.

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 evaluations of issues that they are unable to resolve. This engineer must be comfortable with making decisions while working on these more complex issues. This role requires a firm grasp of time management and organizational skills.

To meet the needs of our customers, working outside normal business hours and on some weekends/holidays is required. In addition to working OT to handle workload and meet required metrics/expectations.

The Raw Materials QC Manager is accountable for GMP compliant laboratory operations according to GMP guidelines. This role is responsible for direct management and supervision of the QC Raw Materials teams performing raw material testing according to USP/EP/JP guideline and releasing raw materials for use in the drug substance and drug product manufacturing process. The Manager, QC Raw Materials is responsible for managing raw material specifications, handling changes from customers on customer owned materials as well as handling and implementing new raw materials and consumables as part of tech transfer activities. In addition, the QC Raw Materials team is responsible for testing, disposition, and release of raw materials and Trackwise support or investigation of deviations including Out of Specification (OOS) results. Provide managerial support for troubleshooting of complex investigations and optimizing laboratory systems. Ensure that the laboratory is maintained in a state of GMP compliance. All documentation is in accordance with GMP and all reported results are accurate. The Manager, QC Raw Materials is the technical subject matter expert (SME) and participates in assessing the testing of raw materials and excipients, represents the QC Raw Materials team during regulatory and customer audits. The Manager models leadership competencies and aids in the development of QC team members.

The Director Quality Systems is responsible for developing, implementing, and maintaining individual sub-systems of the Pharmaceutical Quality Systems (PQS) for FDBT.  Responsibilities will include one or more PQS sub-system: Internal Audit, External (Customer) Audit, Health Authority Inspection, and Remediation.  Lead the assigned team to create a strong quality culture of engaged and motivated staff maintaining strong working relationships with internal and external stakeholders.  Ensure the site PQS sub-system is aligned with the harmonized global FDB PQS, organizational goals and objectives, and areas of continuous improvement.

The Quality Control Raw Materials Chemist I, under general direction, will be responsible for performing routine and non-routine quantitative and qualitative analysis of samples submitted to the Quality Control (QC) Laboratory.

The Senior Production Costing Analyst is responsible for enabling our site to deliver on financial and strategic objectives through forecasting, analysis, and reporting that guide business decisions. This role is integral in managing financial performance and implementing finance strategies to achieve business performance in a cross-functional team environment. The Senior Production Costing Analyst supports the business and drives finance initiatives and decisions. This role is a high performer who exudes a contagious level of positive energy, possesses a high sense of ownership, and has a strong ability to communicate and build rapport with non-financially minded peers.

We have an opportunity for a dedicated team player to be a part of a fast-paced, busy manufacturing environment! Fujifilm, Sonosite, Inc is seeking Manufacturing Associates to join our team. This role has full benefits, a 401K plan, paid time off, plus more perks that come with being a full time Fujifilm Sonosite employee! As a successful candidate you will exhibit manual dexterity, reliability, basic math and computer skills and an aptitude for learning things quickly. 

This position is responsible for performing a variety of tasks associated with manufacturing diagnostic ultrasound transducers.  Specific tasks may include some of the following:

The Automation Engineer 2, DSM - 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 Quality Assurance (QA) Operations Supervisor, will be responsible for the overall performance of the QA group.  The supervisor will handle all associated responsibilities in compliance with Fujifilm quality policies and site SOPs to ensure regulatory compliance.  

Reports to                Senior Manager, Quality Assurance

Work Location         College Station, TX 

The Associate Manufacturing Supervisor is responsible for coordinating manufacturing operations to meet and exceed quality, cost and delivery commitments. Position is a “working” position, in which the individual will supervise the activities of others while assisting in the day-to-day operations.

This position will have supervisory responsibility over a shift of Manufacturing Technicians in a Wafer Fab responsible for the manufacture of MEMS-based products.  Ideal candidates will have demonstrated experience supporting the development of manufacturing excellence across a multi-shift production operation.

Pay range for position: $35 - 45 per hour, commensurate with experience.

Compressed Work Week-Back End Nights - Every Thursday, Friday, Saturday and every other Wednesday.  5:30 pm- 6:00 am