The Director, Engineering Science plays a pivotal role in providing technical leadership and strategic vision within the Manufacturing Science and Technology (MSAT) of the organization. This role assesses and designs processes to integrate new equipment, optimize facilities, and enhance operational capabilities. The Director, Engineering Science leads engineering studies, drives improvements in Drug Substance Manufacturing (DSM), Drug Product and Finished Goods (DPFG), and ensures innovative solutions are implemented effectively. This role is crucial in enhancing site’s process equipment and technology capability offerings and maintaining competitiveness, by making significant contributions to the company’s growth and innovation.

As the Senior Director, Process Engineering & Maintenance, this role is responsible for setting the direction and managing central workstreams in the start-up of a $2 billion project. This role leads the process engineering and process maintenance organizations to ensure the successful start-up and ramp-up to meet client commitments ensuring the equipment maintains a state of readiness. Additionally, this role is responsible for designing and implementing manufacturing processes, equipment, and technology while building the team and ensuring flawless execution by leveraging existing experience as a subject matter expert (SME) and people management capabilities in start-up of Greenfield capital projects and technical projects. The Senior Director drives continuous improvement in process design, cost savings, quality, and resource utilization while incorporating newest technology and resolving engineering problems for optimization.

The Manager of Compliance & Support, DP develops and oversees the manufacturing support team within the drug product scope. This position ensures compliance by addressing and closing gaps, authoring departmental standard operating procedures (SOPs), creating master batch records in electronic systems managing the production scheduler, batch record reviewers, manufacturing execution systems associates, and training coordinators. The role also supports shop floor activities for deviations, corrective and preventive actions (CAPAs), and aids in materials management for production operations.

The Manufacturing Specialist 1, DP performs manufacturing support activities to ensure compliant and reliable production. This role may require flexibility with working hours and shift rotation to support a 24/7 manufacturing facility.

The Tech 1, Instrumentation & Controls (I&C) role is responsible for ensuring the efficiency and operational reliability of the instrumentation and controls that support facility-wide equipment, and facility systems through effective Corrective and Preventive (CAPA) Maintenance and Calibration practices and know-how.

The Investigator 2 is responsible to perform major investigations, identify root and contributing causes, contributes to the creation of effective corrective and preventative actions (CAPA) while ensuring timely closure of assigned investigations. This role also supports senior investigators with complex investigations as needed and provides guidance to junior investigators.

The Scientist 2, QC Chemistry is a technical subject matter expert (SME) responsible for QC analytical chemistry methods used in biological product manufacturing, including chromatography (GC, HPLC, UPLC, SEC), spectroscopy (MS, GC/MS, LC-MS/MS, UV, UV-Vis, FTIR), electrophoresis (GE, non-reducing and reducing CE-SDS, imaged capillary isoelectric focusing (icIEF)), wet chemistry, glycan analysis, sub-visible particle analysis, peptide mapping, and physical appearance, etc. The Scientist 2, QC Chemistry ensures GMP-compliant laboratory operations in accordance with regulatory guidelines. This
role performs technical/compliance reviews and approves analytical results. The role approves laboratory exceptions, invalid assays, deviations, change controls, and corrective and preventative actions (CAPAs). The QC Chemistry Scientist II authors, reviews, and approves SOPs, protocols, and technical reports. The role serves as the subject matter expert (SME) for QC Chemistry in cross-functional projects and meetings.

The Sr. Analyst 1, QC Analytical Development (QCAD) Bioassay supports the implementation of plate and cell-based analytical methods for Technology Transfer (TT) of drug substance (DS) and drug product (DP) into the Quality Control laboratories of FUJIFILM Biotechnologies Diosynth Holly Springs (FDBN). This role supports the transfer and validation of methods such as residuals (HCP, DNA, Protein A), dot blot for product identity, ELISA ID/ Potency and various cell-based assays. The Sr. Analyst 1, QC AD Bioassay ensures Good Manufacturing Practices (GMP) compliant laboratory operations in accordance with regulatory guidelines. This role executes analytical method transfers from clients and author and review procedures, SOPs, and technical reports.

The Production Scheduler, Drug Product Finished Goods is responsible for creating, maintaining, and optimizing daily and long-term production schedules across drug product manufacturing, filling, inspection, and packaging operations. This role ensures timely product delivery and efficient use of resources while adhering to current Good Manufacturing Practices (cGMP). Acting as a central coordination point, the scheduler partners with other departments (e.g., Manufacturing, Planning, Quality, Supply Chain) to align material availability, equipment capacity, and staffing needs with the production plan.

Act as the local Compliance Officer for both of FUJIFILM Biotechnologies sites in North Carolina region.  In addition, they will be the main Compliance contact / support for any questions / requirements for FUJIFILM Biotechnologies.

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 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 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 cross-functional teams to drive continuous improvement and optimize CV practices.

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 Specialist, Drug Substance Manufacturing (DSM) is responsible for partnering in the Quality oversight of DSM project processes. This role provides oversight of validation program execution for these processes and systems to ensure applicable DSM systems and processes are operated/maintained in a validated state throughout their lifecycle, with a focus on consistent policy administration. The QA Specialist, Drug Substance Manufacturing (DSM) ensures QA oversight of day-to-day activities and resolution or mitigation of issues occurring during operation.