Summary:  The Quality Assurance - Compliance Specialist III - Audit and Inspection will support all associated responsibilities in compliance with FUJIFILM Diosynth Biotechnologies quality policies and site SOPs to ensure regulatory compliance.

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

The Director, Clean Utilities is responsible for the ongoing operations of all clean utility systems (WPU, WFI, Clean Air, Clean Steam, Gases) to support Fujifilm’s $3.4B expansion in Holly Springs, North Carolina. This role provides leadership for all utilities engineering focused initiatives and activities and monitors operational milestones and achievements to ensure successful transition in site operations and continued delivery in sustaining operations. Additionally, this role collaborates extensively with internal and external stakeholders ensuring that site team adheres to Current Good Manufacturing Practice (CGMP), and the ways of working, problem-solving best practices, and lessons learned are reviewed promptly. The Director ensures that the right people are assigned to the right tasks and projects providing challenge and enhancement to their skills.

The Director, Manufacturing Support is responsible for leading the department and the associated activities to ensure compliant and reliable drug substance manufacturing. This role applies broad knowledge and expertise in the areas of biopharmaceutical manufacturing, manufacturing support, and
operational excellence. This position provides tactical and strategic direction to the Manufacturing Support team and promotes the behaviors and principles that drive continuous improvement throughout the organization.

The Sample Management Analyst II, under general direction, will be responsible for performing routine and non-routine support of samples submitted to the Quality Control (QC) Laboratory for evaluation. This position works as part of the Sample Management team to manage the receipt, organization and inventory of samples from manufacturing, clients, other Fujifilm facilities and third parties. The Sample Management Analyst II arranges sample shipments for outsource testing and shipments to Clients or other facilities and controls dispensing of samples for QC testing.   

The Supervisor, Utility Maintenance is responsible for overseeing and coordinating the operations of utility systems and the team of utility maintenance for clean and black utilities to ensure smooth and efficient operations. This role focuses on maintaining and managing equipment, vendors, and daily operational activities while ensuring compliance with safety, regulatory, and Good Manufacturing Practices (GMP) standards. Additionally, this role also provides training, technical support, and leadership to the utility operations maintenance team.

As the Software Architect, you will help formulate the technical strategy for our ultrasound platforms working on a combination of short-term and long-term initiatives in order to increase our efficiency and effectiveness. You will also drive technology investments and architectural alignments. This role will also identify and drive cross-company initiatives with clearly defined outcomes and metrics. You will oversee the software architecture of all platforms, with ownership of software capability, re-use, quality and reliability. A key contributing decision maker about which technologies to use, how software should be architected, and the technical direction of our ultrasound platforms. This candidate has a passion for breaking down complex problems and identifying solutions that can be implemented by software teams. 

The Procurement Manager is responsible for executing procurement strategies and initiatives at the Morrisville site as directed by the Regional Procurement Lead. This role involves managing a dynamic team to ensure efficient day-to-day procurement operations while aligning with broader organizational objectives. The Procurement Manager focuses on maximizing value, optimizing processes, and ensuring compliance with procurement standards.

The IP Counsel is a member of the FUJIFILM Holdings America Corporation (“HLUS”) Legal Department reporting to the Chief IP Counsel. The IP Counsel will work on intellectual property matters for HLUS and its subsidiary companies, both independently and in collaboration with members of the HLUS Legal Department and outside counsel.

Summary:  The Process Sciences - Associate Scientist/Engineer, under general direction, functions within a team based organization to actively address cGMP manufacturing issues.  The individual is responsible for analyzing process technologies to assist in the technical transfer of new processes into the manufacturing group.   This individual must work in a collaborative manner to assist the transfer of biological drug processes from process development (internal or client) groups in a CDMO environment.

Who We Are

FUJIFILM Electronic Materials, U.S.A., Inc., is a global leader in chemical solutions which enable the semiconductor industry and the digital universe. We have an exciting opportunity at our Mesa, Arizona facility for a Manufacturing Technician in our Solvents group!

The Role

Manufacturing Technicians perform drum and tote preparation, drum & tote fill, material handling, and sampling duties as assigned. Perform compounding and packaging duties as required.

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 of a team, with growing cross-functional collaboration.

The Regional AD, Procurement is strategic role of developing world-class procurement processes and frameworks. This role is responsible for managing this function and work closely with Finance, Legal, other functions and 3rd parties to ensure procurement activities are carried out in accordance with company standards. This role will be building and leading a business-driven regional team while utilizing your previous experience and skills within procurement strategy, processes, and negotiation to ensure our procurement-related activities foster success of the organization.

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:

We are hiring a Research Scientist – Formulation and Lyophilization. The Research Scientist – Formulation and Lyophilization will be responsible for leading formulation development studies to improve solubility, stability, and bioactivity of recombinant cytokines and growth factors, design and execute lyophilization cycles with a focus on reducing moisture content, improving cake appearance, and maintaining activity. They will evaluate excipients and delivery system compatibility for liquid and lyophilized formats (vials, bags, etc.), and provide scientific guidance to junior team members and support troubleshooting of formulation-related challenges.

Fujifilm Diosynth Biotechnologies in Holly Springs, NC is hosting our second Manufacturing Hiring Event this Summer - INVITE ONLY.

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. We are hiring for night-specific roles; however, all roles may requires flexibility with working hours and/or shift.

We operate on a 2-2-3, 12 hour shift schedule and are hiring for NIGHT SHIFT ONLY.

We have an exciting opportunity at our Carrollton, Texas facility for a Manufacturing Technician!  Our Manufacturing Technicians fill a critical need in FUJIFILM's chemical plant operations. They support the daily operations in our fast-paced production area. As a Manufacturing Technician you will perform hands-on batch processing and liquid production of solvents. Loading and offloading of bulk chemical solvents and blends into tanker trucks, holding vessels, rail cars and drums. Monitor tank truck and rail car loading and unloading.

The Quality Assurance (QA) Analyst II, under general direction, will be responsible for review and/or approval of basic and technical documentation; Drafting and reviewing of internal Quality policies and procedures; Assisting in and performing product related activities; Assisting in and performing Quality audit functions; Identifying process and Quality System improvements; Acting as a QA liaison internally.

Reports to                Supervisor/Manager, QA

Work Location         College Station, TX 

The Automation Engineer 3, MES 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. Additionally, this role participates in designing and maintaining the Manufacturing Execution System (MES).

The LEAD PROJECT TEAM SUPPORT ENGINEER-MI provides remote technical, applications and system support for HCUS customers and supported business units. This role primarily interacts with FUJI Technical Assistance Center (TAC), FUJI customers and other FUJI business units with the management, execution, and administration of operational, billable, and more in-depth projects and support. Supports complex issues where analysis of situations or data requires an in-depth evaluation of variable factors which may include customer impact, HCUS business priorities and regulatory requirements. Provides to assistance to all connected teams on technical and product knowledge and department operating procedures. To meet the needs of our customers and supported business units, working outside of normal business hours and holidays is required.