This role performs 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 Automation Engineer 3, DSM Downstream will provide support to the Drug Substance Manufacturing (DSM) facility. This includes implementation of changes to the Automation systems, updating design documents, executing testing, troubleshooting events, and being a part of Automation on-call support. This role focuses on supporting the delivery of DeltaV logic for Downstream process areas including Buffer Preparation/Hold, Purification – Chromatography (LPC), Viral Filtration (VF), Ultrafiltration (UF), Diafiltration (DF), and Dispensing. 

The Automation Engineer 3, DSM PI Data Historian, will provide Engineering input on the design, implementation, configuration, and testing qualification of the hardware for an Emerson DeltaV control system. Once in Operations, you will be responsible for and have ownership of the ongoing support of the control system hardware, software, and infrastructure.

The Automation Engineer 2, DSM DeltaV Infrastructure, will provide Engineering input on the design, implementation, configuration, and testing qualification of the hardware for an Emerson DeltaV control system. Once in Operations, you will be responsible for and have ownership of the ongoing support of the control system hardware, software, and infrastructure.

The Senior Active Directory Engineer has a critical role in ensuring the global Active Directory environment is secure, scalable, and reliable. Key responsibilities include: 

The Associate Director, Cleaning Validation is responsible for leading and executing Cleaning Validation (CV) activities for a large-scale biologics manufacturing facility in compliance with regulatory requirements, including 21 CFR Parts 11, 210, and 211, as well as ASTM E2500 guidelines. This role ensures that all facility, utility, equipment, and process qualification activities are conducted efficiently and in alignment with Good Engineering Practices (GEP) and Risk-based Validation approach. This role exists to guarantee the integrity and compliance of production systems and to mitigate risks associated with the therapeutic product lifecycle. The Associate Director collaborates with...

The Process Analyst is tasked with analyzing, documenting, and performing gap analysis on finance processes across six sites within the group. This position supports project managers in finance transformation projects and exists to optimize workflow efficiency, enhance cross-functional collaboration, and identify and assess alignment of existing processes. Engaging with various departments, the Process Analyst facilitates sessions for process mapping and optimization, establishes and maintains governance structures, ensuring a cohesive future approach across the organization.

The Finance Transformation Project Manager plays a pivotal role in managing and executing finance-specific projects within Fujifilm Biotechnologies. This role involves overseeing complex, strategic financial change initiatives and process improvements that contribute to the success Fujifilm Biotechnologies, readying the business for 4x revenue growth by FY30. The incumbent will ensure efficient budget management, deliverable tracking, and financial system enhancements crucial for achieving long-term business objectives.

The Automation Engineer 1 provides support to the Drug Substance Manufacturing (DSM) facility. This includes implementation of changes to the Automation systems, updating design documents, executing testing, troubleshooting events, and being a part of Automation on-call support.

The work we do at FUJIFILM Biotechnologies (FB) has never been more important and we are looking for talented candidates to join us. We’re growing our capabilities and looking for passionate, mission-driven people like you who want to make a real difference in people’s lives. Join FDB and help create the next vaccine, cure, or gene therapy in partnership with some of the most innovative biopharma companies across the globe. Here, you’ll work alongside and learn from some of the most dedicated scientists, engineers, and manufacturers in the industry. We’re proud to cultivate a culture that will fuel your passion, energy, and drive.  This is what FDB calls Genki.   Join us and...

The Senior Director of Operations Excellence will be a key leader in Fujifilm Biotechnologies across several areas of the business. The role will be responsible for identifying, planning, and driving improvements across all sites in the business. These improvements will include, but not be limited to, productivity increases, costs savings, revenue increases, and systemic process changes. The role will also have a significant hand in shaping the strategy of the Operations Excellence (OpsExc) team and its agenda for the next 2-3 years.   The ideal candidate...

Utility Maintenance 3 will perform corrective maintenance, routine maintenance, and preventive maintenance on plant utilities equipment following Standard Operating Procedures (SOPs). Complete work orders, daily logs and forms following Good Manufacturing Practices (cGMP) documentation practices and quality standards in a Pharmaceutical Manufacturing plant. Utilities to include high-pressure steam boilers, process wastewater treatment, chillers, water purification systems (water softening and carbon bed filtration, reverse osmosis, deionization equipment, sanitary pumps, and associated equipment), compressed air and dryers, and chilled water.

The Technician 2, Maintenance is responsible for the 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.

The Senior System Manager role is part of diverse Global IT department, which is driving digital transformation across the organization. As part of the Global ERP & Enterprise Services team, this role plays a key role in maintaining and developing the DSM Scheduling System, crucial for streamlining our drug substance production. This role also collaborates closely with team to ensure efficient, compliant IT services, working primarily with SQL, Alteryx, and Tableau. This role captures deployment requests, develop new system features, and strategize alongside our global team. Our culture, defined by Genki, champions simplicity, agility, and a community thriving on diversity and complex...

The CQV Engineer 3 supports the commissioning and qualification of equipment and systems for the site. This role performs validation activities to include but not limited to equipment set up, building dashboards, creating work orders, managing protocols, and reading and reviewing documents. This role ensures equipment and systems comply with regulatory requirements and quality standards while ensuring a successful integration of CQV activities into site projects.

Sr. Specialist 1, QC Lab Support works under moderate supervision, supporting and participating in QC activities related to investigations, deviations, OOS/OOT, CAPAs, and Change Controls. This role assists in creating and maintaining GMP documents and processes, collaborating with stakeholders and QA. This role contributes to customer contact and CLO communication to support QC capabilities in delivering materials and results. This role helps ensure QC compliance with policies and procedures. This role participates in project management and process improvement initiatives, developing skills in risk assessment. The role requires the ability to work effectively both independently and as part...

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 Manager, QC Lab Support is responsible for leading the Lab Support team and the associated activities to ensure compliant and reliable testing for drug substance and drug product. This role applies broad knowledge and expertise in the areas of biopharmaceutical Quality Control for QC Chemistry, QC Bioassay, QC Microbiology, etc. and operational excellence. This Manager, QC Lab Support provides tactical and strategic direction to the QC Lab Support team and promotes the behaviors and principles that drive continuous improvement throughout the organization.

The Automation Engineer 3 will provide support to the Drug Substance Manufacturing (DSM) facility. This includes implementation of changes to the Automation systems, updating design documents, executing testing, troubleshooting events, and being a part of Automation on-call support. This role focuses on leading the Automation scope for delivery of DeltaV logic for CIP & Clean Utilities process areas including Clean-in-Place (CIP), WFI (Water-for-Injection) Generation and Distribution, WPU (Process Water) Generation and Distribution, Clean Steam Generation, and Waste Collection.

The Director, Operational Excellence is responsible for driving continuous improvement initiatives and promoting Lean Sigma methodologies across the manufacturing facility. This role leads the implementation and sustainability of process improvement projects, reduce waste, optimize processes, and ensure that the facility meets its operational goals with a focus on efficiency, quality and cost reduction. This role also helps to define, establish and nurture a continuous improvement culture. This role is responsible for defining what good looks like starting with establishing the foundations of a strong program, developing and rolling out the right tools to be used, training to help all levels...