As a System Manager, ServiceNow you will be part of Global ERP & Enterprise Services team within the FDB IT Department. You will work together with other highly dedicated and skilled colleagues focused on the mission of ensuring a stable, efficient, and compliant IT services. Simplicity and agility...

The Technician 1, Maintenance is responsible for assisting 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 Manufacturing Technician I works directly with a range of technologies. Dependent upon assignment, the range of technologies may include any of the following:

The Associate Director (AD), Program Quality is responsible for building and sustaining the quality relationship with partners through transparent and trusting communications, working with Program Management and site SLTs to provide unprecedented delivery. This role is accountable for the quality aspects of customer programs from initial discussions through end of program review/close. The AD, Program Quality works with customers to define quality requirements and governance for all programs, and agrees the process control strategy for the program, ensuring the right level of quality at the right time and demonstrates adaptability by ensuring processes meet regulatory requirements and support...

The Sr. Program Quality Manager is responsible for programs from the point of Quality Agreement signature through program closure. This role ensures Fujifilm Diosynth Biotechnologies, Holly Springs (FDBN) provides services in alignment with our contracted commitment to clients and our company vision/mission (strategy and compliance). This role is the primary client liaison representing FDBN Quality. The Sr. Program Quality Manager handles an average load of 1-3 programs and receives coaching & guidance from the Senior Director, Global Program Quality.

The QA Associate Manager (Operations DSM Upstream) leads and supervises a team of QA professionals responsible for providing day-to-day risk-based QA support of Drug Substance Manufacturing areas and processes in a fast-paced, dynamic startup environment. This role is the primary point of contact for their team and the first-line escalation point in areas of their responsibility. This role requires collaboration with leadership, site-based customers, and global colleagues.

The Customer Sourcing Specialist is responsible for customer onboarding activities, coordinating material enrollment, supporting tech transfer, and sourcing activities for customer programs at FDBN. Support of the Denmark facility, as needed. This role is a key link between the global sourcing organization and customer program organization for matters related to risk assessment of materials, vendors, new materials, and vendor onboarding activities. This...

The QA Validation Specialist will serve as technical subject matter expert for FDBC validation processes including but not limited to, facilities, utilities and equipment qualification (FUE), manufacturing and laboratory systems and computerized equipment (CSV), and validation software tools.  The main responsibility for this role is to provide QA oversight for validation practices at FDBC.  The role will also provide QA oversight for validation related topics by supporting QMS processes and deliverables such as SOPs, site deviations, CAPAs and change control records. The role will work closely with manufacturing, quality control, quality assurance, supply chain,...

The Senior Financial Business Partner provides strategic financial support to the business. This position requires a blend of financial expertise, business acumen and the ability to influence and drive strategic initiatives. This role acts as a key advisor to the Program Management leadership, supporting all financial elements relating to revenue recognition accounting, contract review and approval and sales to program margin forecasting. This role is also responsible for ensuring financial goals are met and business strategies are effectively implemented. The role involves engaging with business partners to understand business processes, performance, highlighting risks and opportunities, and...

The Manufacturing Specialist 2, MES & DCS performs manufacturing support activities to ensure compliant and reliable production. This role focuses on aspects of recipe configuration and troubleshooting related to DeltaV Distributed Control Systems (DCS) and Manufacturing Execution System (MES). The manufacturing facility will be 24/7 operational and the role may require flexibility with working hours and shift rotation.

The Manufacturing Specialist 2, SAP performs manufacturing support activities to ensure compliant and reliable production. This role focuses on aspects of recipe configuration and troubleshooting related to Systems, Applications, and Products in Data Processing (SAP) material transactions. This manufacturing facility will be 24/7 operational and the role may require flexibility with working days and/or nights and shift rotation.

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: Deviation, CAPA, Change Control, Supplier Quality, Training, Document Control, QA Validation, eQMS, and Quality Management.  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...

The Sr Automation Engineer 1, 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 Manager, QC Laboratory Information Management System (LIMS) is responsible for developing strategic plans for implementing FDB's global Laboratory Information Management System (LIMS). This role harmonizes processes across all current and future FDB sites and leads the transition of QC into a paperless environment. The Manager, QC LIMS guides a team of LIMS experts to translate global and site-specific needs into user requirements, system design, configuration, and implementation plans. This role acts as the primary subject matter expert (SME) for LIMS and focuses on maintaining and continuously enhancing the global LIMS system.

The Vice President of Engineering will be a business leader for the site engineering function. This pivotal role will be responsible for overseeing the engineering functions, including Automation, Process Engineering, Utilities, Commissioning, Qualification, and Validation (CQV), Environmental Health and Safety (EHS), Facility Management and Security, and Capital Projects. The executive role will join site leadership in leading the business and ensuring engineering teams support the business strategy and provide state-of-the-art technical solutions, support robust manufacturing processes, drive continuous improvement initiatives, and upholds the highest standards of quality...

A proactive and driven team player is required to passionately support delivery and embedding of the Data Integrity projects at FDBT. The Quality Assurance (QA) Specialist II for Data Integrity will be responsible for the day to day running of the FDBT Data Integrity Program, performing data integrity assessments, gap confirmation and risk assessments, generate remediation plans and categorize gaps based on business priority and risks.  

We have opportunities for Manufacturing Associates at several levels within our Drug Substance production teams

The Commercial Development Director, (internally known as Commercial Development Manager) will be responsible for business development activities and to identify, manage the initial qualification, and close through the signing of contracts for new business, concentrating on Biologics. 

The Maintenance Technician II, under the supervision of the Facilities Maintenance Supervisor, or designated supervisor will be responsible for performing various aspects of utilities, facilities and process equipment maintenance, utilities operation and support for the Texas Biological Facility (TBF), the Flexible Biological Facility (FBF) and the National Center for Therapeutic Manufacturing (NCTM) on behalf of Fujifilm Diosynth Biotechnology Texas (FDBT).   Primary responsibilities include various...

The Senior Automation Engineer 1, MES (PAS-X) provides support to the Drug Product Finished Goods Manufacturing (DPFG) 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 leads projects and handle complex changes while coordinating with other internal and external groups.