The Raw Material Sampler 3 position is responsible for sampling of materials and products at the Holly Springs FDBN large scale manufacturing facility, which produces Drug Substance (DS), Drug Product (DP), and Finished Goods (FG) products. This role works with multiple functions to support
operations: Warehouse, Supply Chain, Quality Control (QC), and other customers, as needed. The Raw Material Sampler 3 uses Systems and Applications Production (SAP) Enterprise Resource Planning (ERP) system for inventory management and Laboratory Information Management System (LIMS) for sample management while operating in a good manufacturing practice (GMP) facility with standard operating procedures (SOPs).

The Utility Operator 3 will operate, maintain, and repair black and clean utility systems. This role will also be responsible for monitoring mechanical and/or electrical equipment, power distribution, chilled water, gas, domestic and de-ionized water, WFI, clean steam, boilers, compressed air, fire alarm, security, remote building equipment monitoring, sanitary, acid waste, and storm drain systems. Also responsible for daily monitoring of tank farm, supporting lab admin building, building management system (BMS) and critical alarm response. This role will serve as primary contact and communicator to all alarms received in the control room.

The Utility Operator 3 will operate, maintain, and repair black and clean utility systems. This role will also be responsible for monitoring mechanical and/or electrical equipment, power distribution, chilled water, gas, domestic and de-ionized water, WFI, clean steam, boilers, compressed air, fire alarm, security, remote building equipment monitoring, sanitary, acid waste, and storm drain systems. Also responsible for daily monitoring of tank farm, supporting lab admin building, building management system (BMS) and critical alarm response. This role will serve as primary contact and communicator to all alarms received in the control room.

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 of the facility adopt and embed and finishing with ongoing monitoring and performance mgmt. that drives continuous improvement in to our ways of working, identifying issues and mitigating risk to drive the site to be a high performing site that is ambitious to continuously do better than yesterday. 

Utility Operator 2 will operate, maintain, and repair black and clean utility systems. This position will also be responsible for monitoring mechanical and electrical equipment, power distribution, chilled water, process gas, domestic and de-ionized water, water for injection (WFI), clean steam generator and distribution, plant steam boilers, compressed air, fire alarm, security, remote building equipment monitoring, sanitary, acid waste, and storm drain systems. This role will also be responsible for daily monitoring of tank farm, supporting lab admin building, building management system (BMS) and critical alarm response.

Utility Operator 2 will operate, maintain, and repair black and clean utility systems. This position will also be responsible for monitoring mechanical and electrical equipment, power distribution, chilled water, process gas, domestic and de-ionized water, water for injection (WFI), clean steam generator and distribution, plant steam boilers, compressed air, fire alarm, security, remote building equipment monitoring, sanitary, acid waste, and storm drain systems. This role will also be responsible for daily monitoring of tank farm, supporting lab admin building, building management system (BMS) and critical alarm response.

The QA Specialist, Operations is responsible for partnering in the Quality oversight of Drug Substance Manufacturing processes for 12-hour overnight shift. This role collaborates within the DSM Quality team as well as with other cross-functional teams. Ensures that applicable DSM systems and processes are operated/maintained as intended, with a focus on consistent policy administration, QA oversight of activities occurring during the shift and resolution or mitigation of issues occurring during operation.

The QA Specialist, QC Compliance is responsible for partnering in the Quality oversight of the Quality Control area. The QA Specialist helps drive Quality oversight for the direction of all QC laboratory processes, from project phase through operational readiness, and provides oversight of validation program execution for these processes. This role collaborates with other project teams and QA departments at other sites to align strategies and procedures. In operations, the role ensures that all QC laboratory systems and processes are operated and maintained in a validated state throughout their lifecycle, with a focus on consistent policy administration, as well as QA oversight of day-to-day activities and resolution or mitigation of issues. Additionally, this role participates in optimization or improvement initiatives and supports regulatory agency and third-party inspections.

The Financial Analyst supports the organization in delivering on our financial and strategic objectives through forecasting, analysis and reporting that will guide business decisions. This role is ensures our ability to manage our financial performance and implement our financial strategies to achieve business performance in a cross-functional team environment.

The Sr. Specialist 1, QC LIMS supports the Laboratory Information Management system (LIMS) in accordance with appropriate regulatory, corporate, and scientific guidelines. The Sr. Specialist 1, QC LIMS configures, validates and provides ongoing maintenance within the LIMS platform. This role is expected to complete and review change requests, validate configurations, provide user support and troubleshoot as needed. This role is responsible for implementing approved configuration changes within the LIMS platform as outlined in controlled change management records. The role supports documentation revisions in accordance with governing SOPs to ensure the system and procedures operate in a state of control. This role ensures the LIMS system meets the requirements of the LIMS procedures. The Sr. Specialist 1, QC LIMS works closely with Quality Control, Analytical Development, Manufacturing and Quality Assurance to ensure compliance with GMP requirements

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 Engineer or Scientist 2 for Process Validation helps ensure that manufacturing processes meet the validation and regulatory requirements for the process to be reproducible under normal operating conditions. This role contributes to the design, execution, and documentation of process validation protocols for equipment, systems, and manufacturing processes. Additionally, this role works with cross-functional teams to help ensure processes are consistently producing high-quality products in a safe and efficient manner.

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 QA Engineer, Pharmaceutical Quality Systems (PQS) Audits & Inspections is responsible for the day-to-day activities of the Pharmaceutical Quality Systems (PQS) team. This role is primarily responsible for coordinating GMP customer audits and regulatory inspections and supporting the Quality Management Review on a local and global level.

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 business aspirations (e.g. KojoX). The AD, Program Quality works effectively, independently and within a team framework, across all business areas, levels of the organization, and with clients to deliver high quality and ensures timely delivery of QA services. This role operates on both a strategic level with senior executives and facilitates operational elements in actual program execution.

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 Senior Engineer or Scientist 2 of Process Analytics serves as the subject matter expert (SME) and provides technology transfer support, technical oversight, and strategic input across laboratory and manufacturing operations. This role leads junior team members through all aspects of process analytic (PA) activities and provides technical guidance and coaching.