Summary:  Under general direction, the Logistics Specialist II is responsible for the accurate receiving, packing, shipping, and external distribution of cGMP (current Good Manufacturing Practices) and non-GMP materials in support of company operations.

The Manufacturing Supervisor may be assigned to work directly with Upstream, Downstream or Buffer Preparation Unit Operations. This individual will supervise a team of employees directly or indirectly in these production process units.

  The purpose of this job is to provide comprehensive instrument and electrical (I&E) maintenance support throughout the FUJIFILM New Castle Site, ensuring reliable operation of manufacturing plants, labs, and warehouses. Responsibilities include handling I&E maintenance through daily work orders, carrying out preventative maintenance activities, conducting routine inspections and calibrations and progressing emergency repairs under the direction of the Maintenance and Facilities Manager....

The Sr. Engineer, Supplier Quality provides supplier oversight to ensure that suppliers of services or materials to Fujifilm Diosynth Biotechnologies are of the highest quality while conforming to pre-established requirements including cGMPs. This role primarily focuses on supplier quality, working with suppliers to maintain supplier approvals. This role plays a key role in establishing the Supplier Quality System including but not limited to SOP and Specification development, Quality Agreements, Risk Assessments, Supplier Auditing and Supplier Change Notifications.

The Supervisor, Utility Maintenance is responsible for overseeing and coordinating the operations of utility systems and the team of utility maintenance for clean and black utilities to ensure smooth and efficient operations. This role focuses on maintaining and managing equipment, vendors, and daily operational activities while ensuring compliance with safety, regulatory, and Good Manufacturing Practices (GMP) standards. Additionally, this role also provides training, technical support, and leadership to the utility operations maintenance team.

The Quality Assurance (QA) Analyst I, under direct supervision, will be responsible for assisting with the review and/or approval of basic and technical documentation; Drafting and reviewing of internal Quality policies and procedures; Assisting with product related activities; Assisting with Quality audit functions; Identifying process and Quality System improvements.   Reports to     ...

Who We Are   FUJIFILM Electronic Materials, U.S.A., Inc., is a global leader in chemical solutions which enable the semiconductor industry and the digital universe. We have an exciting opportunity at our Mesa, Arizona facility for a Metrology R&D Chemist!  

The Associate 2, EHS is responsible for supporting the development and execution of Environmental, Health, Safety and Sustainability programs. This includes compliance with applicable regulations (Federal, State, Local), codes and standards. As a single point of contact, this position will represent EHS and collaborate with assigned functional operations areas to instill a world class culture of EHS. Additional responsibilities include support of EHS engagement programs (EHS observations, GEMBA), training, audits, inspections, investigations, and collaboration with EHS personnel across the organization.

The Associate 2, EHS is responsible for supporting the development and execution of Environmental, Health, Safety and Sustainability programs. This includes compliance with applicable regulations (Federal, State, Local), codes and standards. As a single point of contact, this position will represent EHS and collaborate with assigned functional operations areas to instill a world class culture of EHS. Additional responsibilities include support of EHS engagement programs (EHS observations, GEMBA), training, audits, inspections, investigations, and collaboration with EHS personnel across the organization.

The Associate Director, EHS drives the implementation and enhancement of FUJIFILM Diosynth Biotechnologies world-class Environment, Health, Safety and Sustainability (EHS) programs. This role is pivotal in fostering a culture that prioritizes employee well-being and safety across all operational facets. The AD, EHS is responsible for ensuring compliance with regulatory standards while nurturing a proactive safety culture that emphasizes the importance of putting people and the planet first in all engagements.

The Cybersecurity Analyst will report to the Manager, Cybersecurity and will conduct initial triage and analysis on cybersecurity alerts and threats which have been detected, threat hunting activities to proactively identify vulnerabilities in company applications, systems and networks, investigate and work with IT Operations members to remediates security vulnerabilities and threats.   The incumbent ensures corporate security measures are effective in mitigating threats and risks and provides consultation on security issues to IT delivery team and local...

The QC Analyst, Bioassay, with direction from manager, executes QC cell- and plate-based analytical methods including protein binding assays, cell-based potency assays, cell culture routine maintenance, and residual testing for DNA, Host Cell Protein (HCP), Protein A/G. The QC Analyst, Bioassay adheres to GMP compliant laboratory operations in accordance with regulatory guidelines. This role generates analytical results and identify laboratory exceptions, invalid assays, deviations, change controls and corrective and preventative actions (CAPAs). The QC Analyst, Bioassay is primarily responsible for executing routine analytical methods in support of manufacturing, and as needed supporting laboratory execution of analytical method transfers...

The Analyst, QC Virology is responsible for supporting QC analytical methods including cell culture, viral infectivity assays, growth and purification of viral stocks, viral titer, and qPCR-based methods. This role supports bioassay methods, including cell- and plate-based methods such as residual DNA, HCP, and protein binding assays. The Analyst, QC Virology generates and reviews Good  Manufacturing Practices (GMP) testing results and assists in identifying laboratory exceptions, invalid assays, deviations, and corrective and preventative actions and identifies areas for laboratory improvement.

The Sr. Analyst 1, QC Virology works with limited direction to execute QC analytical methods requiring aseptic technique, including viral infectivity assays, mammalian cell culture, growth and purification of viral stocks, titering of viral stocks, and PCR-based methods. The Sr. Analyst 1, QC Virology 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 Sr. Analyst 1, QC Virology is primarily responsible for executing routine Virology methods in support of manufacturing, supporting laboratory execution of method qualifications, maintaining cell banks and...

The QA Specialist, Supplier Quality is responsible for the day-to-day activities of administering Supplier Quality activities. This role acts as a point of contact for supplier quality and maintains supplier quality agreements, familiarity with audit programs, and vendor management processes. The QA Specialist, Supplier Quality administers approved supplier lists for the Holly Springs, NC site. This role collaborates internally with multiple QA teams, including Supplier Quality and site-based customers Supply Chain teams to manage and provide updates to suppliers.

We are hiring a Liquid Packaging Technician. The Liquid Packaging Technician will be responsible for product inspection, labeling, case packaging, accountability and quarantine of sterile filled product.   2nd Shift

The Utility Maintenance Apprentice role is an active position aimed at aiding the Utility Maintenance team in maintaining, troubleshooting, and repairing crucial equipment within a pharmaceutical manufacturing setting. Working under the supervision or guidance of experienced technicians and engineers, the apprentice gains expertise in ensuring the dependable operation of utilities such as HVAC, water purification, compressed air, steam, and other vital systems required for pharmaceutical production. This apprenticeship program offers thorough training and skill enhancement in technical areas vital to Utility Operations in the biotech pharmaceutical industry.

The Utility Maintenance Apprentice role is an engaging, hands-on position focused on assisting the Utility Maintenance and Maintenance team with the upkeep, troubleshooting, and repair of Good Manufacturing Practice (GMP) equipment. Under the supervision of management or senior technicians and engineers, the apprentice acquires knowledge of the critical dependencies necessary for the smooth operation of equipment, ensuring pharmaceutical processes are conducted efficiently and meet strict quality standards. The apprenticeship program offers thorough training and skill development in technical domains and GMP standards within a highly regulated environment.

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 and or Advanced Therapies. 

We are hiring for a Manufacturing Technician. This position reports to Production Supervisor. Responsible for operating, cleaning, and general maintenance of the Quicksnap production lines.