This position is intended to report to the Senior Manager, R&D, and working under their supervision, the R&D Engineer supports New Product Development projects. This role develops R&D plans and budgets, and ensures that approved plans are executed on time, within quality guidelines, and within budget. The R&D Engineer provides input on quality, product and manufacturing strategies and is considered a key contributor on all aspects of product development and manufacturing operations. The R&D Engineer conducts medical device development and manufacturing transfer of projects under their responsibility, in close collaboration with marketing, Quality and Regulatory team members and/or Affiliates and contract manufacturer employees involved in the projects. This role provides guidance on product design, especially design for manufacturing and testing. Furthermore, it takes a leadership role, ensuring the development meets the product requirements, is developed in compliance within quality and regulatory guidance and transfers to manufacturing successfully.

The Manufacturing Technician (Environmental Support) works as part of the manufacturing team to deliver high quality therapeutics. The Environment Support Team is responsible for cleaning and sanitization of all controlled areas (CNC and all graded areas) of the facility, including all equipment. The facility and equipment sanitization processes consist of the application of multiple disinfectants in which disinfectant efficacy is supported through efficacy and coupon studies.  The sanitization of all graded areas and equipment is documented via an electronic batch record system.  This team is critical to ensuring that the Manufacturing Environment is consistently maintained in a state of microbial control as to ensure adherence to Manufacturing schedule deliverables.

We are seeking a highly skilled Professional Services Advisor to join our Professional Services Group (PSG). In this role, you will deliver exceptional training, technical support, and consultative services to both external customers and internal teams. Your expertise will be crucial in training customers on industry-specific software solutions, including Fujifilm Revoria Flow, Fiery Cutsheet, color management applications, and calibration hardware. Additionally, you will provide comprehensive operator training for production and multi-function digital printers, ensuring customers maximize the performance and efficiency of their equipment. You will play a key role in expanding PSG sales by building strong relationships and generating revenue through outstanding service delivery.

Location: Central or Western U.S. (major city near an international airport)

Travel: Approximately 80%

The Internal Communications Specialist provides communication support and direction for strategic initiatives and operational topics. This position supports and maintains FDB’s global standards and develops editorial and video content for intranet, publications newsletters, e-boards, presentations and other internal communication channels. This role works closely with members of the FUJIFILM Biotechnologies Communications Team and supports communications for the Morrisville location.

The Sr. Director, Quality Control provides strategic, technical, and operational leadership to the site Quality Control Laboratories. This role proactively leads implementation of GMP industry standard methodologies across the Quality Control Laboratories. The Sr. Director, Quality Control plays a major role in the site operations while remaining adaptable to the changing needs for new clients and programs and is accountable for the sustained and ever improving quality mindset as well as the consistent adherence to current good manufacturing practices (cGMP) throughout the site.

The Director, QA DSM Operations oversees the Quality Product and Validation teams, as well as the batch review and release teams. This role ensures all released batches are manufactured and tested in compliance with Good Manufacturing Practices (GMP) regulations, including, but not limited to maintaining quality systems aligned with CGMP, GDP, and regulatory standards, and ensures product compliance through robust quality systems. This role fosters a strong Quality Culture within the Quality function and across supporting teams. As part of the site Quality leadership team, the Director, QA DSM contributes to the cohesive implementation of quality systems across the Holly Springs, NC site, and ensures alignment with organizational goals and regulatory requirements.

The Senior Analyst 1, QC Chemistry works with limited direction to execute QC Analytical Chemistry methods used in biological product manufacturing, including chromatography, spectroscopy, electrophoresis, wet chemistry, glycan analysis, sub-visible particle analysis, peptide mapping, and physical appearance, etc. The Senior Analyst 1, QC Chemistry, adheres to GMP-compliant laboratory operations in accordance with regulatory guidelines. This role generates analytical results and identifies laboratory exceptions, invalid assays, deviations, change controls, and corrective and preventative actions (CAPAs). The Senior Analyst 1, QC Chemistry is primarily responsible for executing routine analytical methods in support of manufacturing, supporting laboratory execution of analytical method transfers and validations, and training other QC Chemistry laboratory associates. 

The Supervisor, QC Microbiology, is responsible for providing day-to-day supervision, ensuring audit readiness, and planning activities for the laboratory.

The Supervisor, QC Microbiology, is responsible for providing day-to-day supervision, ensuring audit readiness, and planning activities for the laboratory.

The Scientist 1, QC Microbiology supports a broad range of microbiological functions for both raw materials and drug product manufacturing support. This role manages multiple assignments of increasing complexity and responsibility within the Quality Control laboratory in support of these two areas. This role follows procedures and has mastery of a wide variety of microbiological methods specific to raw material and drug product manufacturing and supporting data management processes. The Scientist 1, QC Microbiology effectively and efficiently manages complex or difficult tasks with expertise within the assigned disciplines. This role initially supports the commissioning activities involved in the construction of a new Biopharmaceutical manufacturing facility and laboratory. Flexibility in job roles and assignments are required.

The Technician 2, HVAC/Refrigeration is responsible for the installation, maintenance, and repair of the heating, ventilation, air conditioning, and refrigeration systems/equipment. This role ensures these systems meet the stringent requirements of pharmaceutical manufacturing and storage environments. Additionally, this role is responsible for conducting regular inspections and preventative maintenance on HVAC/R systems to ensure they are operating within the required specifications.

The Intern (Black Utilities) works with the Technical Operations Support (TOS) team, specifically within Plant Engineering. The TOS team is responsible for providing all the utilities to the Site, including: Steam, Air, water and electricity.  As part of the TOS team, the Intern learns about system operations, maintenance strategies and engineering design from experienced TOS team members.   

Start Date: This internship is set to begin on May 26th 2026 for an 11-week duration ending on August 7th 2026.

Relocation: Please note this Internship Opportunity is designed to be 100% Onsite, 40 hours/week and a relocation/housing stipend is not provided.

The Intern (Clean Utilities) works with the Technical Operations Support (TOS) team, specifically within Plant Engineering. The TOS team is responsible for providing all the utilities to the Site, including: Steam, Air, water and electricity.  As part of the TOS team, the Intern learns about system operations, maintenance strategies and engineering design from experienced TOS team members.   

Start Date: This internship is set to begin on May 26th 2026 for an 11-week duration ending on August 7th 2026.

Relocation: Please note this Internship Opportunity is designed to be 100% Onsite, 40 hours/week and a relocation/housing stipend is not provided.

As a Finance Intern, you will benefit from a hands-on experience that will provide you an opportunity to gain in-depth knowledge of our organization and culture. You will gain exposure to different areas of financial applications and processes.  As a valuable team member, you will be given the opportunity to apply your exceptional analytical and problem-solving skills to a wide variety of finance and accounting activities.  You will manage a project from start to finish, and culminate your summer experience by presenting your results to leadership.

Start Date: This internship is set to begin on May 26th 2026 for an 11-week duration ending on August 7th 2026.

Relocation: Please note this Internship Opportunity is designed to be 100% Onsite, 40 hours/week and a relocation/housing stipend is not provided.

The Intern (Drug Substance Manufacturing (DSM) Support and Campaign Lifecycle Management) is part of the DSM support team tasked for preparing Campaign Readiness for Good Manufacturing Practice operations (GMP) in the manufacturing areas DSM 1 and DSM 2. As part of the CLM team, the intern gains hands-on experience with production schedule planning, project management planning and tools, as well as gaining knowledge of process equipment, flows, and execution. 

Start Date: This internship is set to begin on May 26th 2026 for an 11-week duration ending on August 7th 2026.

Relocation: Please note this Internship Opportunity is designed to be 100% Onsite, 40 hours/week and a relocation/housing stipend is not provided.

Position Description

We are hiring a Powder Milling & Cleaning Tech. The Powder Milling & Cleaning Tech will be responsible for the milling of powdered media and cleaning of powder media equipment.

1st Shift: 5am - 1:30pm

The Sr. Analyst 1, QC Microbiology is responsible for leading key operational aspects of the QC Microbiology laboratory. The Sr. Analyst 1, QC Microbiology performs and trains other team members on the microbial testing of all in-process drug substance, drug product, EM/UM, and raw materials samples. This role is responsible for all activities associated with testing in accordance with written procedures. This role primarily works independently with minimal supervision as needed, consults with management on key decisions.

The QC Analyst is responsible for the key operational aspects of the QC Microbiology laboratory. Incumbent will perform microbial testing of all in -process drug substance, drug product, EM/UM, and raw materials samples. Incumbent will be responsible for all associated activities associated with this testing in accordance with written procedures. This position primarily works under minimal supervision as needed. This position will initially be involved in the commissioning activities involved in the construction of a new Biopharmaceutical manufacturing facility and laboratory. Flexibility in job roles and assignments will be required. This may include writing or assisting with document preparation and review, managing project timelines, conducting qualification and validation protocols, and assisting management with training and on-boarding of new staff as needed and in addition to regular work duties and assignments.