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...

The QC Instrumentation Specialist will work independently to perform routine operations, continuous improvement, and life-cycle management of the QC analytical instrumentation program. This role will ensure compliance of QC analytical instrumentation with Data Integrity standards in accordance with regulatory guidelines and company policies and procedures. This role will ensure the performance of routine maintenance, completing periodic reviews of QC analytical instrumentation to confirm compliance and correct deviations and excursions. The role will also support stakeholders with issues and guidance related to QC analytical instruments. The ability to effectively communicate...

The Supply Chain Specialist 3, Compliance is responsible for actions, processes, and audit readiness. This role supports all Supply Chain operations, procedures, systems, processes, and GXP related matters in accordance with the GXP requirements. The SC Specialist 3, Compliance initiates and investigates internal and external exceptions impacting Supply Chain. This role leads the implementation of comprehensive corrective and preventative actions (CAPA) to drive improvements, coordinating vendor change notifications, raw material enrollment and supplier complaints. This role coordinates and is responsible for leading internal and external changes impacting Supply Chain...

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 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

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...

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...

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...

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), 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 and compliance across the Company...

The Senior Global Desktop Engineer is a senior technical position responsible for monitoring, managing, and troubleshooting an organization's end-user computing systems across the FDB. This role is centered on delivering Level 2 and Level 3 support, which includes addressing the most complex technical issues that Level 1 support cannot resolve.    In this role, you will provide essential technical guidance and expertise, diagnosing and resolving high-level technical challenges across a wide range of technologies. This...

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

As an upstream supervisor, you’ll lead and inspire a team of manufacturingassociates, supporting the start up of a new large scale cell culture

The Sr Automation Engineer 1, DSM Upstream 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

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:

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

The Instrumentation & Controls Technician is responsible for ensuring the efficiency and operational reliability of the instrumentation and controls that support facility wide equipment, and facility systems through effective Preventive and Corrective Maintenance and Calibration practices and knowhow. While in project phase, the schedule will be M-F during normal business hours.  Upon transitioning to operations, this position will transition to the appropriate shift that will be defined prior to the transition. You will join an organization focusing on growth, people, and a steep learning curve as well as a diverse workplace with people driven to make a...

This position reports to the Process Engineering Manager, Upstream in support of the Process Equipment team for the Galaxy project, a greenfield construction project in Holly Springs, NC.  The initial assignment is to assume the Responsible Engineer role for the Seed Train unit operations.   As the site moves into commercial operations circa 2025, this position is planned to continue as a Process Engineering role supporting commercial operations, technology transfers, and small capital projects related...

The Computer System Validation (CSV) Engineer III, under general direction, will lead the development and approval of validation documentation, risk assessments, work with project teams to determine which elements should be validated and conduct impact assessment of proposed changed to computerized systems.   Reports to   ...