LFB USA jobs - 71 jobs

The Building Information Modeling (BIM) Services Administrator plays a crucial role in managing and optimizing the use of Computer Aided Design (CAD) and BIM technologies. This position is responsible for maintaining and managing central models, facilitating collaboration among stakeholders, and ensuring that all CAD and BIM processes align with organizational standards. This role works closely with project teams to streamline workflows, enhance data integrity, and support the successful execution of projects. Additionally, this role utilizes a proactive approach to problem-solving in a fast-paced environment while leveraging strong technical knowledge in CAD and BIM technologies from prior experiences. Job Description What You'll Do * Collaborates with IT to implement CAD and BIM systems, manages Autodesk license compliance and availability for users while ensuring timely updates and software availability for specific Autodesk products• Ensures BIM deliverables comply with Good Manufacturing Practice (GMP) documentation and validation requirements• Establishes clear audit trails for all model and data changes• Develops and maintains Client Information Requirements (CIR) with a GMP focus• Enforces compliance with site-specific digital procedures• Audits supply chain BIM Execution Plans (BEPs) to confirm their ability and effectiveness to address critical systems• Oversees Common Data Environment (CDE) ensuring secure, validated, and access-controlled information flows• Confirms metadata includes equipment identification, materials, cleaning validation requirements, and other regulated attributes• Acts as the client representative with design teams, contractors, and validation engineers• Assigns equipment tags, line numbers, and drawing number sin accordance to standards• Reviews change control processes ensuring that any digital model or data change is reflected in GMP documentation• Organizes, develops, and maintains engineering and facility documentation and drawings• Provides CAD and BIM support to engineering, maintenance, and facility projects regarding the creation, revision, and handling of drawing and valve lists, line schedules, work orders, and other activities• Creates and revises BIM documentation for both GMP and non-GMP requests• Trains CAD and BIM team members on core application skills and standards and BIM serves users on procedures• Collaborates with other FUJIFILM sites to ensure alignment across the company, as needed• Performs other duties, as assigned Minimum Requirements: * Bachelor's degree in engineering or related field with 5 years of experience in the AEC industry; or• Associate's degree within a technical discipline or drafting and design with 7 years of experience in the AEC industry; or• High School Diploma/GED with 9 years of experience in the AEC industry• 3+ years in a BIM coordinator, specialist or similar role• Experience with Revit, AutoCAD, and Navisworks for modeling, clash detection and coordination• Prior experience training or mentoring project teams on BIM workflows Preferred Requirements: * Bachelor's degree in engineering• 5 years in a BIM coordinator or similar role• Prior client-facing experience, including leading coordination meetings and delivering BIM-related presentations Working Conditions & Physical Requirements: * Ability to discern audible cues * Ability to inspect or perform a task with 20/20 corrected vision, visual acuity, including distinguishing color. * Ability to stand for prolonged periods of time, up to 30 minutes * Ability to sit for prolonged periods of time, up to 30 minutes * Ability to conduct activities using repetitive motions that include writs, hands and/or fingers To all agencies: Please, no phone calls or emails to any employee of FUJIFILM about this requisition. All resumes submitted by search firms/employment agencies to any employee at FUJIFILM via-email, the internet or in any form and/or method will be deemed the sole property of FUJIFILM, unless such search firms/employment agencies were engaged by FUJIFILM for this requisition and a valid agreement with FUJIFILM is in place. In the event a candidate who was submitted outside of the FUJIFILM agency engagement process is hired, no fee or payment of any kind will be paid.

Director, QA Drug Substance Operations Are you a strategic leader with expertise in managing teams of QA professionals and collaborating seamlessly with manufacturing and support functions? If you are motivated and possess strong operational excellence skills, we have an exceptional opportunity for you to lead and grow in a world-class Quality organization as the Director, QA Drug Substance Operations. In this role, you will oversee our Quality Product and Validation teams, along with the batch review and release teams. Your responsibilities will include ensuring that all released batches are manufactured and tested in strict compliance with Good Manufacturing Practices (GMP) regulations. You will maintain quality systems that align with CGMP, GDP, and other regulatory standards, ensuring product compliance through robust quality systems. You will play a crucial part in fostering a strong Quality Culture within the Quality function and amongst supporting teams. As a member of the site Quality leadership team, you will contribute to the cohesive implementation of quality systems across the Holly Springs, NC site, ensuring alignment with organizational goals and regulatory requirements. Join us and take your career to the next level in our dynamic and innovative environment. Company Overview FUJIFILM Biotechnologies is building the future of bioproduction in Holly Springs, North Carolina. By end of 2025, we'll open North America's largest end-to-end CDMO biopharmaceutical manufacturing facility, offering drug substance production, fill-finish, and packaging under one roof. We're looking for passionate, mission-driven people to help us realize this exciting vision and deliver the next vaccine, cure, or therapy. We offer a dynamic work environment and we're proud to cultivate a culture that will fuel your purpose, energy, and drive-what we call Genki. Ready to shape the future of medicine? Let's transform healthcare together! Holly Springs, North Carolina, combines small-town warmth with proximity to Raleigh's thriving tech scene, making it the perfect blend of community and opportunity. Fujifilm is globally headquartered in Tokyo with over 70,000 employees across four key business segments of healthcare, electronics, business innovation, and imaging. We are guided and united by our Group Purpose of "giving our world more smiles." Visit: *************************************************** Job Description What You'll Do * Develops strategic plans for QA team operations, sets measurable goals, and oversees the supervision, development, and performance of personnel to foster a high-performing team environment * Leads and manages the QA DSM Operations teams, including the Batch Review and Release teams and the Quality Engineering/Validation team, ensuring alignment with organizational goals and regulatory requirements * Ensures effective resource allocation and capacity planning to meet operational demands while maintaining compliance with quality standards * Provides comprehensive QA oversight and support for manufacturing operations and associated support functions such as Process Science, Engineering Science, Process Engineering, Validation, and Automation * Ensures the quality assurance (QA) review and approval of exceptions and CAPAs, while also facilitating the timely review and approval of process performance qualification (PPQ) protocols and reports, continuous process monitoring protocols and reports, risk assessments, changeover processes, equipment release, and sample plans. Additionally, approves drug substance (DS) retain requests as necessary * Establishes robust QA processes to ensure adherence to cGMP regulations and alignment with client Quality Agreements * Assesses the impact of system and process modifications, ensuring effective oversight of change management processes to maintain validated states of manufacturing systems throughout their lifecycle * Ensures Quality batch Disposition and collaborates with partners, external stakeholders and other parts in the Quality function, as needed * Oversees validation activities during startup and commercial operations to ensure compliance with regulatory standards * Approves critical lifecycle documentation, including risk assessments, product/process/equipment specifications, functional specifications, traceability matrices, qualification protocols, validation plans, and validation summary reports * Ensures documentation is accurate, complete, and compliant with regulatory expectations to support operational readiness * Drives a robust Quality Culture across the site by fostering collaboration within the operational peer network and embedding quality principles into daily activities * Acts as a key advocate for quality excellence across all levels of the organization * Generates, reviews, and approves QA documentation, procedures, and processes to support operational readiness objectives in a CGMP-regulated facility * Oversees the preparation of trend reports for process performance and environmental monitoring to ensure continuous improvement. * Collaborates with other FUJIFILM Diosynth Biotechnologies sites to harmonize processes, share best practices, and maximize efficiency across the network * Actively participates in cross-functional initiatives to align global quality strategies * Partners with internal stakeholders and clients to define functional specifications and process together with monitoring of Quality metrics for GMP Operations * Works with internal teams and clients to manage data used for continuous manufacturing, validation activities, continuous improvement initiatives, and regulatory commitments * Drives the team's efforts in curating critical knowledge and developing best practices in Quality and Operations disciplines * Serves as a key stakeholder in business development efforts while defining the future large-scale operations model, including contributing to the site's digital roadmap for GxP process data management * Mentors employees and oversees their development to ensure the team is positioned for long-term growth and success * Partners with HR, Talent Acquisition, and other stakeholders to attract top talent while developing effective retention strategies * Evaluates team performance regularly, implements measures to improve productivity and engagement levels, and identifies high-potential employees for further development opportunities * Performs other duties, as assigned Minimum Requirements: * Bachelor's degree in engineering, life sciences with 13+ years of related experience OR• Master's degree in engineering, life sciences with 11+ years of related experience OR• Ph.D. in engineering, life sciences with 9+ years of related experience• 10+ years of people management, leadership, and team management experience• Experience in cGMP manufacturing operations and/or Quality role in an FDA/EMA regulated facility.• Experience and working knowledge of ICHQ7 and 21CFR part 820 and part 11 and EU GMP vol 4 including ALCOA+ guidelines.• Experience collaborating and interacting with a global team. * Training and/or familiarity with Quality Risk Management principles Preferred Requirements: * 10+ years' experience in a GMP quality assurance (QA) role in commercial biopharmaceutical facility • Experience in other GMP functions (manufacturing, MSAT, Engineering)• Strong track record of driving operational excellence• Experience with the following processes such as,TrackWise, Veeva, SAP, Syncade Physical and Work Environment Requirements: Ability to discern audible cues. Ability to stand for prolonged periods of time up to 120 minutes Ability to sit for prolonged periods of time up to 120 minutes Ability to conduct activities using repetitive motions that include writs, hands and/or fingers. Ability to conduct work that includes moving objects up to 10 pounds. To all agencies: Please, no phone calls or emails to any employee of FUJIFILM about this requisition. All resumes submitted by search firms/employment agencies to any employee at FUJIFILM via-email, the internet or in any form and/or method will be deemed the sole property of FUJIFILM, unless such search firms/employment agencies were engaged by FUJIFILM for this requisition and a valid agreement with FUJIFILM is in place. In the event a candidate who was submitted outside of the FUJIFILM agency engagement process is hired, no fee or payment of any kind will be paid. EEO Information Fujifilm is committed to providing equal opportunities in hiring, promotion and advancement, compensation, benefits, and training regardless of nationality, age, gender, sexual orientation or gender identity, race, ethnicity, religion, political creed, ideology, national, or social origin, disability, veteran status, etc. ADA Information If you require reasonable accommodation in completing this application, interviewing, completing any pre-employment testing, or otherwise participating in the employee selection process, please direct your inquiries to our HR Department (FDBN_****************).

The Production Technician 1 assists with the execution of manufacturing processing steps and activities in a Current Good Manufacturing Practice (CGMP) environment. Flexibility with working hours and shift rotation is essential to effectively support the 24/7 manufacturing facility. Company Overview At FUJIFILM Biotechnologies, we're leading the charge in advancing tomorrow's medicines. If you want to be a part of life-impacting projects alongside today's most innovative biopharmaceutical companies, FUJIFILM Biotechnologies could be the right place for you. From our Bioprocess Innovation Center to our cGMP-compliant manufacturing site, we thrive on collaboration, creativity, and purpose. Whether your expertise lies in research, manufacturing, or production, you'll find a home here where your efforts directly improve patients' lives. Together, let's shape the future of healthcare. Situated at the cross-section of Morrisville and Research Triangle Park (RTP), North Carolina, our site is at the heart of a booming biotech hub surrounded by top universities, vibrant communities, and various outdoor opportunities. Fujifilm is globally headquartered in Tokyo with over 70,000 employees across four key business segments of healthcare, electronics, business innovation, and imaging. We are guided and united by our Group Purpose of "giving our world more smiles." Visit: *************************************************** Job Description Major Accountabilities: * Assists in the execution of validation protocols according to CGMP standard operating procedures (SOPs) * Maintains training to performs all required activities * Executes and documents manufacturing processing steps or support activities, process monitoring and control under supervision of qualified trainers in at least one functional or support function (with minimal supervision) * Performs in-process sampling and testing (e.g., pH, conductivity, visual inspection) under supervision * Performs other duties, as assigned Knowledge, Skills & Abilities: * Ability to follow technical instruction, perform tasks, and document accurately * Basic understanding of CGMP, safety, and operational procedures * Willingness to work in a team environment Minimum Education and Experience Requirements: * High School Diploma/GED with 1-2 years of related experience; or * Associate degree in life science with no prior experience Preferred Education and Experience Requirements: * 1+ years of experience in a cGMP manufacturing environment * BioWorks Certificate Physical Demands: * Will work in environment which may necessitate respiratory protection. * Ability to discern audible cues. * Ability to inspect or perform a task with 20/20 corrected vision, visual acuity, including distinguishing color. * Ability to ascend or descend ladders, scaffolding, ramps, etc. * Ability to stand for prolonged periods of time up to 240 minutes. * Ability to sit for prolonged periods of time up to 240 minutes. * Ability to conduct activities using repetitive motions that include wrists, hands and/or fingers. * Ability to conduct work that includes moving objects up to 33 pounds. * Ability to bend, push or pull, reach to retrieve materials from 18" to 60" in height, and use twisting motions. * Will work in warm/cold environments (0-100F) To all agencies: Please, no phone calls or emails to any employee of FUJIFILM about this requisition. All resumes submitted by search firms/employment agencies to any employee at FUJIFILM via-email, the internet or in any form and/or method will be deemed the sole property of FUJIFILM, unless such search firms/employment agencies were engaged by FUJIFILM for this requisition and a valid agreement with FUJIFILM is in place. In the event a candidate who was submitted outside of the FUJIFILM agency engagement process is hired, no fee or payment of any kind will be paid. * #LI-Onsite EEO Information Fujifilm is committed to providing equal opportunities in hiring, promotion and advancement, compensation, benefits, and training regardless of nationality, age, gender, sexual orientation or gender identity, race, ethnicity, religion, political creed, ideology, national, or social origin, disability, veteran status, etc. ADA Information If you require reasonable accommodation in completing this application, interviewing, completing any pre-employment testing, or otherwise participating in the employee selection process, please direct your inquiries to our HR Department (HR_*****************).

The Warehouse Associate 2 position is responsible for storage, handling, and distribution of materials and products. This role supports Warehouse operations in receiving, shipping, and/or logistics throughout FDBN and works with multiple functions to support operations (e.g., Manufacturing, Quality, Process Sciences), The Warehouse Associate 2 uses Systems Applications and Products (SAP) ERP system for inventory management, cycle counting, and shipping activities while operating in a good manufacturing practice (GMP) facility with standard operating procedures (SOPs). Job Description What You'll Do * Supports Warehouse Operations to include unloading/loading materials in both receiving and shipping dock areas, and sample shipments• Supports production operations with materials and product movements for manufacturing areas: Drug Substance, Drug Product, Finished Goods, Weigh/Dispense and Raw Material Sampling• Uses SAP ERP system to perform goods issuance, receipts, picking, and shipping• Executes document warehouse activities using standard operating procedures (SOPs), work instructions, and other applicable documentation in GxP operations• Uses SAP ERP system to conduct inventory management by performing cycle counts, bin checks, and materials management• Maintains current training to perform all required activities with Warehouse operations• Uses a variety of powered industrial trucks (PIT) (e.g., electric pallet jack, forklift), sometimes at heights of over 30 feet• Attends and participates in department GEMBA and safety walks• Assists and supports the execution of qualification activities and validation protocols periodically for temperature-controlled units, and all controlled environments in the Warehouse area (e.g., Ambient, Cold, Freezers, Hazardous/Flammable)• Interfaces with Raw Material Sampling and Weigh and Dispense, management and outside departments• Travels up to 10%, as required• Performs other duties, as assigned Basic Requirements * High School Diploma or GED with 4+ years related experience in a manufacturing environment; OR• Associate's degree in Life sciences or similar area with 2+ years related experience in a manufacturing environment; OR• Equivalent Military training and experience Preferred Requirements * 2 years + direct experience in a cGMP manufacturing environment * Bioworks or BTEC Capstone cGMP coursework• Forklift certification WORKING CONDITIONS & PHYSICAL REQUIREMENTS * Will work in environment operating a motor vehicle or Powered Industrial Truck * Ability to ascend or descend ladders, scaffolding, ramps, etc. * Ability to stand for prolonged periods of time - Up to 240 Minutes * Ability to sit for prolonged periods of time - Up to 240 Minutes * Ability to conduct activities using repetitive motions that include wrists, hands and/or fingers. * Ability to operate machinery and/or power tools. * Ability to conduct work that includes moving objects up to 33 pounds * Ability to bend, push or pull, reach to retrieve materials from 18" to 60" in height, and use twisting motions. * Will work in warm/cold environments * Will work in heights greater than 4 feet.

The Internal Event Planner leads the planning and execution of site wide company events both small and large sizes. This role manages end to end planning and execution of events along with managing a wide range of internal- and potentially external relationships and stakeholders. This role as internal event planner is pivotal in creating an engaging environment for all employees. The role requires a people-focused, self-motivated, and collaborative professional who is organized, detail-oriented, able to multitask, and hands-on. Company Overview FUJIFILM Biotechnologies is building the future of bioproduction in Holly Springs, North Carolina. By end of 2025, we'll open North America's largest end-to-end CDMO biopharmaceutical manufacturing facility, offering drug substance production, fill-finish, and packaging under one roof. We're looking for passionate, mission-driven people to help us realize this exciting vision and deliver the next vaccine, cure, or therapy. We offer a dynamic work environment and we're proud to cultivate a culture that will fuel your purpose, energy, and drive-what we call Genki. Ready to shape the future of medicine? Let's transform healthcare together! Holly Springs, North Carolina, combines small-town warmth with proximity to Raleigh's thriving tech scene, making it the perfect blend of community and opportunity. Fujifilm is globally headquartered in Tokyo with over 70,000 employees across four key business segments of healthcare, electronics, business innovation, and imaging. We are guided and united by our Group Purpose of "giving our world more smiles." Visit: *************************************************** Job Description What You'll Do * Plans and organizes internal events, which includes, but is not limited to researching and hiring vendors, aligning agendas and speakers, booking venues, planning transportation, inviting participants, planning activities, packing event materials and creating name badges and signage. • Communicates directly with stakeholders throughout the event planning process to provide updates, align on event goals, coordinate guest list and vendor specifications, and ensure all parties understand relevant information and details. • Collaborates and coordinates / project manage extensively across our many functions to execute evets, including but not limited to: Internal Communications, Facilities, Safety (EHS), Procurement, our People First Committee, External Relations, our Executive Assistants and key stakeholders. • Meets with leaders and executives as necessary to discuss and plan event specifications such as scope, format, budget, administrative details, and special requirements. • Negotiates contracts with venue personnel, caterers, A/V providers, and other vendors to acquire necessary services and activities for events while meeting budgetary objectives. • Plans, Monitors, Host and executes events from preparation and set-up through teardown / clean-up to ensure adherence to planned format, compliance with regulations, resolution of issues, and overall satisfaction of participants. • Performs post-event tasks promptly such as evaluating with stakeholders to ensure satisfaction, reviewing invoices and bills, approving payments, and documenting issues and resolutions. • Evaluates potential locations, providers, vendors, and other professionals frequently to determine viability for future events and build a personal knowledge base to better serve stakeholders. • Performs other duties, as assigned Basic Requirements * High School Diploma or GED with 9 years of progressively responsible experience OR• Bachelor's degree in communications or other related area with 5 years of experience in event management or related field• 3+ years of experience in corporate events, events management, or at event agency • Previous onsite event experience Preferred Requirements * Experience working with all levels of management, including executives • Experience managing a high volume of projects, events and vendors • Experience supporting multiple events of varying sizes at any one time • Prior experience in fast-paced environment with competing deadlines • Experience in project management and proven ability to drive events from idea to execution involving a number of collaborators. WORKING CONDITIONS & PHYSICAL REQUIREMENTS * Ability to stand for prolonged periods of time * Ability to sit for prolonged periods of time * Ability to conduct activities using repetitive motions that include writs, hands and/or fingers * Ability to conduct work that includes moving objects up to 10 pounds To all agencies: Please, no phone calls or emails to any employee of FUJIFILM about this requisition. All resumes submitted by search firms/employment agencies to any employee at FUJIFILM via-email, the internet or in any form and/or method will be deemed the sole property of FUJIFILM, unless such search firms/employment agencies were engaged by FUJIFILM for this requisition and a valid agreement with FUJIFILM is in place. In the event a candidate who was submitted outside of the FUJIFILM agency engagement process is hired, no fee or payment of any kind will be paid. EEO Information Fujifilm is committed to providing equal opportunities in hiring, promotion and advancement, compensation, benefits, and training regardless of nationality, age, gender, sexual orientation or gender identity, race, ethnicity, religion, political creed, ideology, national, or social origin, disability, veteran status, etc. ADA Information If you require reasonable accommodation in completing this application, interviewing, completing any pre-employment testing, or otherwise participating in the employee selection process, please direct your inquiries to our HR Department (FDBN_****************).

The Manufacturing Associate 3, Drug product is responsible for Component/Parts Preparation, Thawing and Formulation of Drug Substance, Sterile Filling and Visually Inspecting of Drug Product (DP). This role supports projects which influence manufacturing processes for Drug Product Manufacturing including training of new colleagues. Maintains compliance of cGMP documents and to assist in qualification of equipment and all aspects of startup of the DPFG facility. This manufacturing facility will be 24/7 operational and the role may require to be flexible with working hours and shift rotation Company Overview FUJIFILM Biotechnologies is building the future of bioproduction in Holly Springs, North Carolina. By end of 2025, we'll open North America's largest end-to-end CDMO biopharmaceutical manufacturing facility, offering drug substance production, fill-finish, and packaging under one roof. We're looking for passionate, mission-driven people to help us realize this exciting vision and deliver the next vaccine, cure, or therapy. We offer a dynamic work environment and we're proud to cultivate a culture that will fuel your purpose, energy, and drive-what we call Genki. Ready to shape the future of medicine? Let's transform healthcare together! Holly Springs, North Carolina, combines small-town warmth with proximity to Raleigh's thriving tech scene, making it the perfect blend of community and opportunity. Fujifilm is globally headquartered in Tokyo with over 70,000 employees across four key business segments of healthcare, electronics, business innovation, and imaging. We are guided and united by our Group Purpose of "giving our world more smiles." Visit: *************************************************** Job Description What You'll Do * Leads, executes and documents manufacturing processing steps and/or manufacturing support activities, process monitoring and control• Performs in-process testing (pH, conductivity, visual inspection)• Executes validation protocols according to cGMP Standard Operating Procedures (SOPs)• Maintains training to perform all required manufacturing activities• Assists and/or lead cycle counts and manage materials for the assigned manufacturing functional area• Performs Operations for all aspects of Drug Product (e.g., Parts Washer, Autoclave, Formulation, Filling, and Visual Inspection)• Assists the lead with tasks in manufacturing activities• Assists with the coordination of daily shift activities• This role may require shift work (weekend and potential for nights)• Performs other duties as assigned Basic Requirements * High School Diploma or GED with 4+ years of direct experience in cGMP manufacturing environment• Associate's Degree + 2 years direct experience in cGMP manufacturing environment OR• Bachelor's Degree, preferably Life Sciences or Engineering OR• Equivalent Military training or experience Preferred Requirements * Qualified Experience on unit operation (e.g., Parts Washer, Autoclave Operation, Compounding/Formulation, Filling with Isolator Technology, or Manual/Automated Visual Inspection) * BioWorks or BTEC Capstone cGMP coursework preferred WORKING CONDITIONS & PHYSICAL REQUIREMENTS * Be exposed to an environment that may necessitate respiratory protection * May work in Mechanical/Production spaces that may require hearing protection and enrollment in a hearing conservation program * Will work in environment operating a motor vehicle or Powered Industrial Truck * Ability to discern audible cues * Ability to inspect or perform a task with 20/20 corrected vision, visual acuity, including distinguishing color * Ability to ascend or descend ladders, scaffolding, ramps, etc * Ability to stand for prolonged periods of time * Ability to sit for prolonged periods of time * Ability to conduct activities using repetitive motions that include wrist, hands and/or fingers * Ability to operate machinery and/or power tools * Ability to conduct work that includes moving objects up to 33 pounds * Ability to bend, push or pull, reach to retrieve materials from 18" to 60" in height, and use twisting motions * Will work in heights greater than 4 feet To all agencies: Please, no phone calls or emails to any employee of FUJIFILM about this requisition. All resumes submitted by search firms/employment agencies to any employee at FUJIFILM via-email, the internet or in any form and/or method will be deemed the sole property of FUJIFILM, unless such search firms/employment agencies were engaged by FUJIFILM for this requisition and a valid agreement with FUJIFILM is in place. In the event a candidate who was submitted outside of the FUJIFILM agency engagement process is hired, no fee or payment of any kind will be paid. EEO Information Fujifilm is committed to providing equal opportunities in hiring, promotion and advancement, compensation, benefits, and training regardless of nationality, age, gender, sexual orientation or gender identity, race, ethnicity, religion, political creed, ideology, national, or social origin, disability, veteran status, etc. ADA Information If you require reasonable accommodation in completing this application, interviewing, completing any pre-employment testing, or otherwise participating in the employee selection process, please direct your inquiries to our HR Department (FDBN_****************).

The Supervisor, Maintenance is responsible for overseeing and coordinating the operations of maintenance systems and the team of process maintenance technicians within assigned area to support Drug Product (DP) or Drug Substance Manufacturing (DSM) 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 provides training, technical support, and leadership to the process maintenance team. Multiple openings across day and night shifts Job Description What You'll Do * Supervises a team of maintenance technicians within assigned area (DP/DSM) fostering a culture of continuous learning and development•Manages and oversees the performance of preventative maintenance and repairs on equipment within assigned area (DP/DSM), including viral skids, bioreactors, pressure vessels, pumps, centrifuges, clean-in-place skids, chrome columns, or filling line, automation inspection line, formulation and isolation equipment•Troubleshoots DP/DSM system issues, coordinates timely repairs to minimize downtown while adhering to compliance and safety standards•Performs routine inspections and analysis to identify areas for improvement and implements energy-saving measures to minimize operational costs and environmental impact•Responds to equipment failures and emergencies promptly to ensure continuous operations•Assists in recovering DP/DSM systems for emergencies, including power outages, fire alarms, and adverse weather events•Ensures compliance with GMP, Occupational Safety and Health Administration (OSHA), and other regulatory standards•Maintains accurate records of maintenance activities and work orders, documents incidents reported by technicians, and updates standard operating procedures (SOPs), as needed•Participates in cross-departmental meetings to provide technical expertise•Supports and assists with implementing process improvement initiatives•Supports site operations and handles emergency work orders outside regular working hours, as needed•Collaborates on the development and implementation of safety procedures and risk assessments•Enforces all company policies (e.g., time off, shift work, inclement weather) that directly impact employees•Completes required administrative tasks (e.g., timecard approvals, time off requests, expense reports, etc.)•Participates in the recruitment process and retention strategies to attract and retain talent•Addresses performance gaps, employee questions and concerns, and partners with HR as needed for resolution•Performs other duties, as assigned. Knowledge & Skills * Advanced knowledge of mechanical, electrical, and control systems•Effective communication, both written and oral•Ability to work in a team environment•Willingness to coach, lead, and develop a team•Demonstrated knowledge of Computerized Maintenance Management System (CMMS) or other data tracking software•Ability to present information to others•Knowledge of Lean Six Sigma methodologies or other continuous improvement techniques•Must be able to support 24/7 manufacturing facility, including shift, on-call and weekends, as needed Basic Requirements •High School Diploma/GED with 8+ years of experience in maintenance within a DP/DSM operations or related field; or•Associate's degree in mechanical, electrical, applied engineering, or industrial technology with 6+ years of experience in maintenance within a DP/DSM operations or related field•Previous experience leading, supervising, or managing others•Prior experience working in a GMP environment•Experience using Microsoft Office (e.g., Word, Excel, Outlook, etc.) Preferred Requirements •Associate's degree in mechanical, electrical, applied engineering, or industrial technology•1+ years of people management experience and leading cross-functional teams•Experience in large pharma / biotech operations or project•Experience in manufacturing or biological products, DP/DSM equipment, or pharmaceutical manufacturing•Experience developing and implementing preventative maintenance systems PHYSICAL REQUIREMENTSPHYSICAL DEMANDSWill work in environment which may necessitate respiratory protection. No X YesMay work in Mechanical/Production spaces that may require hearing protection and enrollment in a hearing conservation program. No X YesWill work in environment operating a motor vehicle or Powered Industrial Truck. No Yes XAbility to discern audible cues. No X YesAbility to inspect or perform a task with 20/20 corrected vision, visual acuity, including distinguishing color. No X YesWORKING ENVIRONMENTPHYSICAL DEMANDSAbility to ascend or descend ladders, scaffolding, ramps, etc. No X YesAbility to stand for prolonged periods of time. No X Yes 240 minutes (If yes, may specify frequency/duration: up to 15, 30, 120, 240 minutes) Ability to sit for prolonged periods of time. No X Yes 240 minutes (If yes, may specify frequency/duration: up to 15, 30, 120, 240 minutes) Ability to conduct activities using repetitive motions that include writs, hands and/or fingers. No X YesAbility to operate machinery and/or power tools. No X YesAbility to conduct work that includes moving objects up to X pounds. No X Yes If yes, 10 lbs. X 33 lbs.Ability to bend, push or pull, reach to retrieve materials from 18" to 60" in height, and use twisting motions. No X Yes ENVIRONMENTAL CONDITIONSWill work in warm/cold environments. No X Yes 0-115F Range (If yes, specify approximate temperature ranges.) Will work in outdoor elements such as precipitation and wind. No X YesWill work in small and/or enclosed spaces. No X YesWill work in heights greater than 4 feet. No X Yes Our programs are designed to focus on maintaining and enhancing all pillars of health with a robust benefits package including medical, dental, vision and prescription drug coverage with the option of a Health Savings Account with company contributions. In addition, we offer an industry leading 401(k) savings plan, insurance coverage, employee assistance programs and various wellness incentives. We support life-work balance with paid vacation time, sick time, and company holidays. Explore a supportive environment that enriches both your personal and professional growth!

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. Company Overview FUJIFILM Biotechnologies is building the future of bioproduction in Holly Springs, North Carolina. By end of 2025, we'll open North America's largest end-to-end CDMO biopharmaceutical manufacturing facility, offering drug substance production, fill-finish, and packaging under one roof. We're looking for passionate, mission-driven people to help us realize this exciting vision and deliver the next vaccine, cure, or therapy. We offer a dynamic work environment and we're proud to cultivate a culture that will fuel your purpose, energy, and drive-what we call Genki. Ready to shape the future of medicine? Let's transform healthcare together! Holly Springs, North Carolina, combines small-town warmth with proximity to Raleigh's thriving tech scene, making it the perfect blend of community and opportunity. Fujifilm is globally headquartered in Tokyo with over 70,000 employees across four key business segments of healthcare, electronics, business innovation, and imaging. We are guided and united by our Group Purpose of "giving our world more smiles." Visit: *************************************************** Job Description What You'll Do * Performs non-routine complex testing, identifies requirements and executes actions as part of change control process. Assists and guides others in the lab with routine testing * Performs high throughput, right-first time work to meet production schedules and project milestones with minimal/no supervision * Leads qualification and study directed testing activities * Reviews and evaluates advanced lab testing results * Acts as a qualified trainer and Subject Matter Expert (SME) of multiple tests * Authors, reviews, and edits documents and study protocols • Supports intermediate investigations of OOS assays and events * Ensures compliance with cGMP and participates in audits and inspections * Supports laboratory management and mentors' others on the team, as needed * Leads LEAN lab and six sigma principles and applies them to laboratory processes * Acts as project leader for projects in the lab and department * Leads audit readiness and participates/supports for the team * Performs other duties, as assigned Minimum Requirements: * Bachelor's degree in chemistry, Biochemistry, Microbiology or other relevant scientific discipline with 5+ years' experience OR * Master's degree in chemistry, Biochemistry, Microbiology or other relevant scientific discipline with 3+ years' experience OR * PhD with 1+ years of applicable industry experience * 3+ years of experience working in a regulated GMP environment * Expert understanding of GMP, GLP, GDP requirements * Experience and proficient knowledge in Microbiology theory * Experience and proficient knowledge of Microbiology testing and laboratory experience, specific to both Drug product manufacturing support and raw materials testing * Advanced LIMS experience * Advanced experience with document control including writing and editing technical documents and presentations Preferred Requirements: * SME level knowledge in Microbiology theory * SME level knowledge of Microbiology testing and laboratory experience, specific to both Drug product manufacturing support and raw materials testing * Investigations training (Trackwise or similar) * LEAN/6S certification * Familiarity with global regulatory guidelines and testing implications Physical and Work Environment Requirements: Will work in environment which may necessitate respiratory protection X No Yes May work in Mechanical/Production spaces that may require hearing protection and enrollment in a hearing conservation program. X No Yes Will work in environment operating a motor vehicle or Powered Industrial Truck. X No Yes Ability to discern audible cues. No X Yes Ability to inspect or perform a task with 20/20 corrected vision, visual acuity, including distinguishing color. No X Yes Ability to ascend or descend ladders, scaffolding, ramps, etc. x No Yes Ability to stand for prolonged periods of time. No X Yes Daily up to 60 minutes (If yes, may specify frequency/duration: up to 15, 30, 120, 240 minutes) Ability to sit for prolonged periods of time. No X Yes Daily up to 60 minutes (If yes, may specify frequency/duration: up to 15, 30, 120, 240 minutes) Ability to conduct activities using repetitive motions that include writs, hands and/or fingers. No X Yes Ability to operate machinery and/or power tools. X No Yes Ability to conduct work that includes moving objects up to X pounds. No X Yes If yes, X 10 lbs. 33 lbs. Ability to bend, push or pull, reach to retrieve materials from 18" to 60" in height, and use twisting motions. No X Yes Will work in warm/cold environments X No Yes Range (If yes, specify approximate temperature ranges.) Will work in outdoor elements such as precipitation and wind. X No Yes Will work in small and/or enclosed spaces. No X Yes Will work in heights greater than 4 feet. No X Yes * -- To all agencies: Please, no phone calls or emails to any employee of FUJIFILM about this requisition. All resumes submitted by search firms/employment agencies to any employee at FUJIFILM via-email, the internet or in any form and/or method will be deemed the sole property of FUJIFILM, unless such search firms/employment agencies were engaged by FUJIFILM for this requisition and a valid agreement with FUJIFILM is in place. In the event a candidate who was submitted outside of the FUJIFILM agency engagement process is hired, no fee or payment of any kind will be paid. EEO Information Fujifilm is committed to providing equal opportunities in hiring, promotion and advancement, compensation, benefits, and training regardless of nationality, age, gender, sexual orientation or gender identity, race, ethnicity, religion, political creed, ideology, national, or social origin, disability, veteran status, etc. ADA Information If you require reasonable accommodation in completing this application, interviewing, completing any pre-employment testing, or otherwise participating in the employee selection process, please direct your inquiries to our HR Department (FDBN_****************).

Have you ever found yourself asking what really matters in a high performing operations facility? Here at Fujifilm Biotechnologies we believe the secret is in our ability to turn good intentions into consistent, scalable results. When organizations commit to disciplined processes and continuous improvement, they see tangible benefits across performance, customers, and people. Sound easy? It's not - it takes not only discipline, processes and metrics but a strong cultural foundation and belief in the value that Operational Excellence can provide not only to a site overall, but for each personal individually. It has to be embedded in everything we do - not just because we say so but because each of us should want to. Bottom line: Operational excellence is the engine that converts strategy into consistent, scalable performance-reducing costs, delighting customers, empowering teams, and strengthening long-term resilience. At the site, we have been looking for months for the perfect Director, Operational Excellence and we have not landed on THE candidate yet. This person will be responsible for defining what Operational Excellence looks like for this site as part of the Fujifilm Biotechnologies network, build a ridiculously strong team to support and embedding the team within the business functions and operations to really drive continuous improvement across the site in a consistent way. The leader for this team needs to be passionate about what they do, why it is important and be able to make Operational Excellence spread across the site in an organic, fast paced way that delivers results. We foundationally believe having the right leader and team in this space will be what sets us up for success and sets us apart from the others. If this kind of challenge, autonomy and passion is what gets you to jump out of bed in the morning - this role might just be for you. If you join the Fujifilm Biotechnologies site in Holly Springs, you will find quickly that this is a site that is not looking to be 'okay' or 'average' - we are looking to set the bar for others to follow and to demonstrate why we are the chosen partner for biopharmaceutical manufacturing at a large scale. Company Overview FUJIFILM Biotechnologies is building the future of bioproduction in Holly Springs, North Carolina. By end of 2025, we'll open North America's largest end-to-end CDMO biopharmaceutical manufacturing facility, offering drug substance production, fill-finish, and packaging under one roof. We're looking for passionate, mission-driven people to help us realize this exciting vision and deliver the next vaccine, cure, or therapy. We offer a dynamic work environment and we're proud to cultivate a culture that will fuel your purpose, energy, and drive-what we call Genki. Ready to shape the future of medicine? Let's transform healthcare together! Holly Springs, North Carolina, combines small-town warmth with proximity to Raleigh's thriving tech scene, making it the perfect blend of community and opportunity. Fujifilm is globally headquartered in Tokyo with over 70,000 employees across four key business segments of healthcare, electronics, business innovation, and imaging. We are guided and united by our Group Purpose of "giving our world more smiles." Visit: *************************************************** Job Description Company Overview FUJIFILM Biotechnologies is building the future of bioproduction in Holly Springs, North Carolina. By end of 2025, we'll open North America's largest end-to-end CDMO biopharmaceutical manufacturing facility, offering drug substance production, fill-finish, and packaging under one roof.We're looking for passionate, mission-driven people to help us realize this exciting vision and deliver the next vaccine, cure, or therapy. We offer a dynamic work environment and we're proud to cultivate a culture that will fuel your purpose, energy, and drive-what we call Genki. Ready to shape the future of medicine? Let's transform healthcare together! Holly Springs, North Carolina, combines small-town warmth with proximity to Raleigh's thriving tech scene, making it the perfect blend of community and opportunity. Fujifilm is globally headquartered in Tokyo with over 70,000 employees across four key business segments of healthcare, electronics, business innovation, and imaging. We are guided and united by our Group Purpose of "giving our world more smiles." Visit: *************************************************** What You'll Do * Defines and leads creation of program to be deployed for Operational Excellence principles through the manufacturing facility, including use of tools such as DMAIC, Value Stream Mapping, Kaizen, GEMBAs, 5S.Hires, Manages, Coaches and develops a strong team of Lean Sigma experts for the site * Defines organization vision and mission, providing a goal for the organization to drive Six Sigma at all levels * Maintains knowledge of industry trends and best practices in Lean Six Sigma methodologies * Partners with cross-functional teams to identify areas for improvement and develop action plans and collaborate to implement process enhancements * Establishes and monitors KPIs to track success of Lean Sigma * Ensures the improvement are standardized and maintained over time through use of visual mgmt., standard work procedures and ongoing audits * Creates and manages processes for sustaining improvements and ensuring that gains are sustained long term * Develops and maintains documentation for process improvement initiatives * Designs and delivers training sessions on Lean Sigma tools for employees at all levels, ensuring understanding and practical application * Acts as Subject Matter Expert (SME) for Lean Sigma methodologies, providing guidance and support as necessary * Mentors and trains staff at all levels on Lean Sigma principles and practices to foster a culture of continuous improvement * Facilitates workshops and meetings to drive continuous improvement efforts * Supports change management processes during the introduction of Lean Sigma tools, methods and initiatives * Overcomes resistance to change by demonstrating the value of process improvements and engaging employees in the transformation journey * Monitors project progress and ensure alignment with organizational goals * Reports on project outcomes and key performance indicators to stakeholder * Prioritizes and manages multiple projects simultaneously, ensuring that timelines, budgets and resources ae effectively aligned with the facility's operational goals * Develops and implements strategies for eliminating bottlenecks, reducing cycle times and improving throughput * Works closely with department leaders to identify critical areas for improvement and implement actionable solutions * Analyzes data to identify trends, root causes, and improvement opportunities * Creates an environment which enables success including goals, measures, coaching, and communication, among others * Completes required administrative tasks (e.g., timecard approvals, time off approvals, expense reports etc.) * Addresses performance gaps, employee questions and concerns, and partners with HR as needed for resolution * Performs other duties, as assigned Minimum Requirements: * Master's degree in related field with 11+ years of experience; ORBachelor's degree with 13+ years of experience;Lean Belt Certification * 10+ years of people management, leadership & team management experience3 years Lean Sigma leadership experience5 years' experience in GMP manufacturing Experience in process improvement and project management.Experience in a similar role, preferably within GMP manufacturing environment Working knowledge of Lean management principles and Six Sigma methodologies Experience and proven track record for designing and implementing a Lean Sigma program. * Strong analytical skills with proficiency in statistical software. Preferred Requirements: * Proven track record of successful process improvement initiatives * Experience in leading cross-functional teams Physical and Work Environment Requirements: Will work in environment which may necessitate respiratory protection. May work in Mechanical/Production spaces that may require hearing protection and enrollment in a hearing conservation program. Ability to discern audible cues. Ability to stand for prolonged periods of time up to 60 minutes. Ability to sit for prolonged periods of time up to 240 minutes. Ability to conduct activities using repetitive motions that include wrists, hands and/or fingers. Ability to conduct work that includes moving objects up to 10 pounds. To all agencies: Please, no phone calls or emails to any employee of FUJIFILM about this requisition. All resumes submitted by search firms/employment agencies to any employee at FUJIFILM via-email, the internet or in any form and/or method will be deemed the sole property of FUJIFILM, unless such search firms/employment agencies were engaged by FUJIFILM for this requisition and a valid agreement with FUJIFILM is in place. In the event a candidate who was submitted outside of the FUJIFILM agency engagement process is hired, no fee or payment of any kind will be paid. EEO Information Fujifilm is committed to providing equal opportunities in hiring, promotion and advancement, compensation, benefits, and training regardless of nationality, age, gender, sexual orientation or gender identity, race, ethnicity, religion, political creed, ideology, national, or social origin, disability, veteran status, etc. ADA Information If you require reasonable accommodation in completing this application, interviewing, completing any pre-employment testing, or otherwise participating in the employee selection process, please direct your inquiries to our HR Department (FDBN_****************).

The Program Management intern will have the opportunity to work with the Program Management team and other functions to further develop our ways of working and leveraging the good practices from our sister site in Denmark as we transition from startup to operations. Within Program Management, we are building the processes and tools that will support planning and delivery of customer programs from the point of contract signature through program closure. The program management department works to ensure first class customer service, aligning our contracted commitment to clients with our company vision/mission. 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. Company Overview FUJIFILM Biotechnologies is building the future of bioproduction in Holly Springs, North Carolina. By end of 2025, we'll open North America's largest end-to-end CDMO biopharmaceutical manufacturing facility, offering drug substance production, fill-finish, and packaging under one roof. We're looking for passionate, mission-driven people to help us realize this exciting vision and deliver the next vaccine, cure, or therapy. We offer a dynamic work environment and we're proud to cultivate a culture that will fuel your purpose, energy, and drive-what we call Genki. Ready to shape the future of medicine? Let's transform healthcare together! Holly Springs, North Carolina, combines small-town warmth with proximity to Raleigh's thriving tech scene, making it the perfect blend of community and opportunity. Fujifilm is globally headquartered in Tokyo with over 70,000 employees across four key business segments of healthcare, electronics, business innovation, and imaging. We are guided and united by our Group Purpose of "giving our world more smiles." Visit: *************************************************** Job Description What You'll Do Under the direct supervision, support and guidance of the manager: * Development of Program Management processes for transitioning Programs from Tech Transfer to Commercial phase and routine manufacture * Development of metrics and dashboards to support status and updates on commercial program delivery, drug product program delivery, handoff/transition of customer relationship from commercial team to Program Mangement * Build framework to enhance communication and partnership across Program Management organization with Denmark site * Performs other duties as assigned Basic Requirements * Currently enrolled in an Associate's Degree program with a Life Science or Business focus OR• Currently enrolled in an Business or Scientific Undergraduate or Master's degree Program• Proficient in Microsoft Word, Excel, and PowerPoint Preferred Requirements * Prior experience in Pharma/Biotech/Chemical Industry WORKING CONDITIONS & PHYSICAL REQUIREMENTS * Ability to discern audible cues * Ability to ascend or descend ladders, scaffolding, ramps, etc * Ability to stand for prolonged periods of time - up to 60 minutes * Ability to sit for prolonged periods of time - up to 240 minutes * Ability to conduct activities using repetitive motions that include writs, hands and/or fingers * Ability to conduct work that includes moving objects up to 10 pounds To all agencies: Please, no phone calls or emails to any employee of FUJIFILM about this requisition. All resumes submitted by search firms/employment agencies to any employee at FUJIFILM via-email, the internet or in any form and/or method will be deemed the sole property of FUJIFILM, unless such search firms/employment agencies were engaged by FUJIFILM for this requisition and a valid agreement with FUJIFILM is in place. In the event a candidate who was submitted outside of the FUJIFILM agency engagement process is hired, no fee or payment of any kind will be paid. EEO Information Fujifilm is committed to providing equal opportunities in hiring, promotion and advancement, compensation, benefits, and training regardless of nationality, age, gender, sexual orientation or gender identity, race, ethnicity, religion, political creed, ideology, national, or social origin, disability, veteran status, etc. ADA Information If you require reasonable accommodation in completing this application, interviewing, completing any pre-employment testing, or otherwise participating in the employee selection process, please direct your inquiries to our HR Department (FDBN_****************).

The Manufacturing Lead executes and leads manufacturing processing steps, associated activities, and assists the supervisor/manager, as needed. The Lead adheres to and helps ensures all activities performed within the designed shift comply with Current Good Manufacturing Practice (CGMP) and other safety or quality standards. Flexibility with working hours and shift rotation is essential to effectively support the 24/7 manufacturing facility. Company Overview At FUJIFILM Biotechnologies, we're leading the charge in advancing tomorrow's medicines. If you want to be a part of life-impacting projects alongside today's most innovative biopharmaceutical companies, FUJIFILM Biotechnologies could be the right place for you. From our Bioprocess Innovation Center to our cGMP-compliant manufacturing site, we thrive on collaboration, creativity, and purpose. Whether your expertise lies in research, manufacturing, or production, you'll find a home here where your efforts directly improve patients' lives. Together, let's shape the future of healthcare. Situated at the cross-section of Morrisville and Research Triangle Park (RTP), North Carolina, our site is at the heart of a booming biotech hub surrounded by top universities, vibrant communities, and various outdoor opportunities. Fujifilm is globally headquartered in Tokyo with over 70,000 employees across four key business segments of healthcare, electronics, business innovation, and imaging. We are guided and united by our Group Purpose of "giving our world more smiles." Visit: *************************************************** Job Description Responsibilities: * Adheres to strict safety protocols and contributes to building a culture of safety within the manufacturing environment * Leads, executes, and documents manufacturing processing steps or support activities, process monitoring and control within a functional area, ensuring compliance with standard operating procedures (SOPs) and Current Good Manufacturing Practice (CGMP) regulations * Oversees, leads, or performs in-process sampling and testing (e.g., pH, conductivity, visual inspection) * Executes validation protocols according to CGMP SOPs and provides approval as a back-up for the supervisor/manager, as needed * Trains and mentors junior associates to enhance team capabilities * Supports scheduling daily activities on the manufacturing floor and serves as a back-up for the supervisor, as needed * Leads troubleshooting for operational issues * Assists the supervisor with shift huddles and tier escalations, investigations, and continuous improvement projects * Serves as the functional lead for manufacturing execution responsibilities * Contributes to manufacturing continuous improvement efforts * Serves as the subject matter expert (SME) in at least two core responsibilities for manufacturing assigned area * Maintains training to perform all required activities * Performs other duties, assigned Requirements: * High School Diploma/GED with 8+ years of experience in a CGMP manufacturing environment; or * Associate's degree in life science with 6+ years of experience in a CGMP manufacturing environment; or * Bachelor's degree in life science with 4+ years of experience in a CGMP environment; or * Equivalent Military training or experience Preferred Requirements: * Experience with multiple unit operation (e.g., Cell Culture, Fermentation, etc.) and fully qualified in at least one functional area Physical Demands: * Ability to ascend or descend ladders, scaffolding, ramps, etc. * Will work in environment which may necessitate respiratory protection. * Ability to inspect or perform a task with 20/20 corrected vision, visual acuity, including distinguishing color. * Ability to stand for prolonged periods of time up to 240 minutes * Ability to sit for prolonged periods of time up to 240 minutes. * Ability to conduct activities using repetitive motions that include wrists, hands and/or fingers. * Ability to conduct work that includes moving objects up to 33 pounds. * Ability to bend, push or pull, reach to retrieve materials from 18" to 60" in height, and use twisting motions Environmental Conditions: * Will work in warm/cold environments (0-100F). To all agencies: Please, no phone calls or emails to any employee of FUJIFILM about this requisition. All resumes submitted by search firms/employment agencies to any employee at FUJIFILM via-email, the internet or in any form and/or method will be deemed the sole property of FUJIFILM, unless such search firms/employment agencies were engaged by FUJIFILM for this requisition and a valid agreement with FUJIFILM is in place. In the event a candidate who was submitted outside of the FUJIFILM agency engagement process is hired, no fee or payment of any kind will be paid. * #LI-Onsite EEO Information Fujifilm is committed to providing equal opportunities in hiring, promotion and advancement, compensation, benefits, and training regardless of nationality, age, gender, sexual orientation or gender identity, race, ethnicity, religion, political creed, ideology, national, or social origin, disability, veteran status, etc. ADA Information If you require reasonable accommodation in completing this application, interviewing, completing any pre-employment testing, or otherwise participating in the employee selection process, please direct your inquiries to our HR Department (HR_*****************).

This position is intended to test and support the software in order to provide a competitive product to the company. In addition, you will use manual and tool assisted testing of new and existing features in medical device software systems. Company Overview At FUJIFILM Healthcare Americas Corporation, we're on a mission to innovate for a healthier world, and we need passionate, driven people like you to help us get there. Our cutting-edge healthcare solutions span diagnostic imaging, enterprise imaging, endoscopic and surgical imaging, as well as in-vitro diagnostics. But we don't stop at healthcare; our Non-Destructive Testing (NDT) team harnesses advanced radiography solutions to keep transportation infrastructure, aerospace, and oil and gas assets safe and running smoothly. Ready to innovate, collaborate, and make a difference? Join us and bring your big ideas to life while working in a dynamic, flexible environment that fuels your creativity and drive. Our headquarters is in Lexington, Massachusetts, an inspiring healthcare research hub in a historic town. Fujifilm is globally headquartered in Tokyo with over 70,000 employees across four key business segments of healthcare, electronics, business innovation, and imaging. We are guided and united by our Group Purpose of "giving our world more smiles." Visit: *************************************************** Job Description Duties and Responsibilities: * Create and maintain automation framework for UI tests. * Create CI tools to increase team efficiency. * Strong manual testing skill. * Create test cases within the prescribed architecture and coding standards using C#, JavaScript or other advanced coding language. * Investigate and debug test failures, updating tests or reporting bugs as necessary and provide test coverage analysis based on automation results. * Create and execute performance tests on web application. * Produce clear and effective reports for various performance metrics. * Good knowledge of performance testing and performance testing best practices. * Analyze product performance and scalability across the entire hardware and software system to develop solutions to improve. * Study customer behavior to predict real world user scenarios. * Be motivated, proactive, and detail oriented. * Comply with all applicable U.S. Food and Drug Administration (U.S. FDA) medical device regulatory requirements, applicable ISO 13485 standard requirements and all other applicable laws, regulations, and standards. Qualifications: Experience: * Zero to two years of experience with Web Development, Web Performance testing tools. * Basic Experience in C#, JavaScript, and PowerShell. * Experience in .NET, Microsoft Team Foundation Server (TFS), and Microsoft Test Manager (MTM), and knowledge in Jenkins is a plus. * Familiarity with Web application and REST APIs. * Familiar with concepts of Continuous integration and Continuous Delivery. * Selenium Webdriver is a plus. Education: * Graduate of an approved school of Radiologic Technology or other diagnostic imaging discipline. BS degree preferred. Master's Degree desired. Special Skills or Other Job Requirements: * Works well in multiple projects at once with a high degree of attention to detail.• Ability to collaborate and thrive in a cross-functional, fast-paced, team environment. Physical Requirements: The position requires the ability to perform the following physical demands and/or have the listed capabilities: * The ability to sit up 75-100% of applicable work time. * The ability to use your hands and fingers to feel and manipulate items, including keyboards, up to 100% of applicable work time. * The ability to stand, talk, and hear for 75% of applicable work time. * The ability to lift and carry up to ten pounds up to 20% of applicable work time. * Close Vision: The ability to see clearly at twenty inches or less. Travel: * Occasional (up to 10%) travel may be required based on business need. In the event that COVID-19 vaccine mandates issued by the federal government, or by state or local government become effective and enforceable, the Company will require that the successful candidate hired for positions covered under relevant government vaccine mandate(s) be fully vaccinated against COVID-19, absent being granted an accommodation due to medical or sincerely held religious belief or other legally required exemption. Applicants to positions where vendor credentialing or other similar requirements exist to enter facilities will be required to comply with the credentialing requirements of the facilities, including complying with vaccine requirements. For all positions, the Company encourages vaccination against COVID-19 and requires that the successful candidate hired be willing to test for the COVID-19 virus periodically and wear a face covering indoors as required, absent being granted an accommodation due to medical or sincerely held religious belief or other legally required exemption EEO Information Fujifilm is committed to providing equal opportunities in hiring, promotion and advancement, compensation, benefits, and training regardless of nationality, age, gender, sexual orientation or gender identity, race, ethnicity, religion, political creed, ideology, national, or social origin, disability, veteran status, etc. ADA Information If you require reasonable accommodation in completing this application, interviewing, completing any pre-employment testing, or otherwise participating in the employee selection process, please direct your inquiries to our HR Department (****************************** or ***************.

The internship role is to support basic and routine laboratory activities in MSAT lab at Fujifilm Biotechnologies in Holly Springs. This role provides ad-hoc support to laboratory scientists in the execution of experiments in support of large-scale manufacturing (Drug Substance Manufacturing - DSM) and tech transfers. 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. Company Overview FUJIFILM Biotechnologies is building the future of bioproduction in Holly Springs, North Carolina. By end of 2025, we'll open North America's largest end-to-end CDMO biopharmaceutical manufacturing facility, offering drug substance production, fill-finish, and packaging under one roof. We're looking for passionate, mission-driven people to help us realize this exciting vision and deliver the next vaccine, cure, or therapy. We offer a dynamic work environment and we're proud to cultivate a culture that will fuel your purpose, energy, and drive-what we call Genki. Ready to shape the future of medicine? Let's transform healthcare together! Holly Springs, North Carolina, combines small-town warmth with proximity to Raleigh's thriving tech scene, making it the perfect blend of community and opportunity. Fujifilm is globally headquartered in Tokyo with over 70,000 employees across four key business segments of healthcare, electronics, business innovation, and imaging. We are guided and united by our Group Purpose of "giving our world more smiles." Visit: *************************************************** Job Description What You'll Do Under the direct supervision, support and guidance of the manager: * Preparation of buffers for Downstream operations and media for Upstream cell culture operations * Set-up of laboratory equipment (bioreactors, filtration units) * Picking samples up from DSM (admittance to DSM requires that the intern does not have make-up or permanent visible jewelry) * Sampling of bioreactors * Raw material sourcing including ordering and inventory control * Housekeeping in the lab (operating dishwasher, staging waste for collection, general lab clean up). Basic Requirements * Currently enrolled in an Associate's Degree program with a Life Sciences focus OR• Currently enrolled in an Engineering or Scientific Undergraduate or Master's degree Program• Proficient in Microsoft Word, Excel, and PowerPoint Preferred Requirements * Prior experience in Pharma/Biotech/Chemical Industry• Prior hands-on technical experience (in a laboratory or manufacturing environment) WORKING CONDITIONS & PHYSICAL REQUIREMENTS * Ability to discern audible cues * Ability to ascend or descend ladders, scaffolding, ramps, etc * Ability to stand for prolonged periods of time - up to 60 minutes * Ability to sit for prolonged periods of time - up to 240 minutes * Ability to conduct activities using repetitive motions that include writs, hands and/or fingers * Ability to conduct work that includes moving objects up to 10 pounds To all agencies: Please, no phone calls or emails to any employee of FUJIFILM about this requisition. All resumes submitted by search firms/employment agencies to any employee at FUJIFILM via-email, the internet or in any form and/or method will be deemed the sole property of FUJIFILM, unless such search firms/employment agencies were engaged by FUJIFILM for this requisition and a valid agreement with FUJIFILM is in place. In the event a candidate who was submitted outside of the FUJIFILM agency engagement process is hired, no fee or payment of any kind will be paid. EEO Information Fujifilm is committed to providing equal opportunities in hiring, promotion and advancement, compensation, benefits, and training regardless of nationality, age, gender, sexual orientation or gender identity, race, ethnicity, religion, political creed, ideology, national, or social origin, disability, veteran status, etc. ADA Information If you require reasonable accommodation in completing this application, interviewing, completing any pre-employment testing, or otherwise participating in the employee selection process, please direct your inquiries to our HR Department (FDBN_****************).

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. Company Overview FUJIFILM Biotechnologies is building the future of bioproduction in Holly Springs, North Carolina. By end of 2025, we'll open North America's largest end-to-end CDMO biopharmaceutical manufacturing facility, offering drug substance production, fill-finish, and packaging under one roof. We're looking for passionate, mission-driven people to help us realize this exciting vision and deliver the next vaccine, cure, or therapy. We offer a dynamic work environment and we're proud to cultivate a culture that will fuel your purpose, energy, and drive-what we call Genki. Ready to shape the future of medicine? Let's transform healthcare together! Holly Springs, North Carolina, combines small-town warmth with proximity to Raleigh's thriving tech scene, making it the perfect blend of community and opportunity. Fujifilm is globally headquartered in Tokyo with over 70,000 employees across four key business segments of healthcare, electronics, business innovation, and imaging. We are guided and united by our Group Purpose of "giving our world more smiles." Visit: *************************************************** Job Description What You'll Do Under the direct supervision, support and guidance of the manager: * Work closely to support the department in development and implementation of processes * Conduct research, ask questions, gather, and analyze data * Prepare and/or review documents, reports and/or presentations * Work closely with supervisor to determine internship project and achieve project goals * Final presentation of assigned project at the conclusion of the internship * Search for opportunities for continuous improvement * Interact with department, cross-functional groups, and senior leadership * Attend social and professional networking events * Analyze budgets against actuals and forecast * Assist in process optimization efforts to achieve more effective and efficient processes * Engage with a variety of stakeholders across the organization for improving financial processes * Establish internal controls for mitigation of risk * Participates in risk review and analysis processes, including assistance with reporting * Ad hoc management reporting requests * Prepare and analyze various financial data sets Basic Requirements * Currently enrolled in an Associate's Degree program with a Business Focus OR• Currently enrolled in a Business Focused Undergraduate or Master's degree Program• Proficient in Microsoft Word, Excel, and PowerPoint Preferred Requirements * Prior experience in Pharma/Biotech/Chemical Industry• Prior hands-on technical experience (in a laboratory or manufacturing environment) WORKING CONDITIONS & PHYSICAL REQUIREMENTS * Ability to discern audible cues * Ability to ascend or descend ladders, scaffolding, ramps, etc * Ability to stand for prolonged periods of time - up to 60 minutes * Ability to sit for prolonged periods of time - up to 240 minutes * Ability to conduct activities using repetitive motions that include writs, hands and/or fingers * Ability to conduct work that includes moving objects up to 10 pounds To all agencies: Please, no phone calls or emails to any employee of FUJIFILM about this requisition. All resumes submitted by search firms/employment agencies to any employee at FUJIFILM via-email, the internet or in any form and/or method will be deemed the sole property of FUJIFILM, unless such search firms/employment agencies were engaged by FUJIFILM for this requisition and a valid agreement with FUJIFILM is in place. In the event a candidate who was submitted outside of the FUJIFILM agency engagement process is hired, no fee or payment of any kind will be paid. EEO Information Fujifilm is committed to providing equal opportunities in hiring, promotion and advancement, compensation, benefits, and training regardless of nationality, age, gender, sexual orientation or gender identity, race, ethnicity, religion, political creed, ideology, national, or social origin, disability, veteran status, etc. ADA Information If you require reasonable accommodation in completing this application, interviewing, completing any pre-employment testing, or otherwise participating in the employee selection process, please direct your inquiries to our HR Department (FDBN_****************).

The Intern (Supply Chain) supports the Warehouse, Raw Material Sampling, and Weigh & Dispense operations tasked with assisting with operational projects and new business processes including working with third party logistics providers (3PLs), visual management implementation, document management. As part of the Supply Chain team, the Intern gains firsthand experience with supporting incoming material receipt, material movement and identification, and collaborating between supply chain and other teams. 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. Company Overview FUJIFILM Biotechnologies is building the future of bioproduction in Holly Springs, North Carolina. By end of 2025, we'll open North America's largest end-to-end CDMO biopharmaceutical manufacturing facility, offering drug substance production, fill-finish, and packaging under one roof. We're looking for passionate, mission-driven people to help us realize this exciting vision and deliver the next vaccine, cure, or therapy. We offer a dynamic work environment and we're proud to cultivate a culture that will fuel your purpose, energy, and drive-what we call Genki. Ready to shape the future of medicine? Let's transform healthcare together! Holly Springs, North Carolina, combines small-town warmth with proximity to Raleigh's thriving tech scene, making it the perfect blend of community and opportunity. Fujifilm is globally headquartered in Tokyo with over 70,000 employees across four key business segments of healthcare, electronics, business innovation, and imaging. We are guided and united by our Group Purpose of "giving our world more smiles." Visit: *************************************************** Job Description What You'll Do Under the direct supervision, support and guidance of the manager: * Collaborates with experienced Supply Chain team members on identified project(s). * Creates and delivers presentation on identified project to Site Leadership Team at the conclusion of internship. * Documents and updates operational procedures * Provides suggestions to improve business processes for operational efficiencies * Gowns into classified for visual management implementation and to gain process knowledge, as needed * Assists with development of material pack guide for 3PL * Assists with ensuring procedures and practices are accurate and are documented * Performs other duties, as assigned Basic Requirements * Currently enrolled in an Associate's Degree program with a Life Sciences focus OR• Currently enrolled in an Engineering or Scientific or Supply Chain Undergraduate or Master's degree Program• Proficient in Microsoft Word, Excel, and PowerPoint Preferred Requirements * Prior experience in Pharma/Biotech/Chemical Industry• Prior hands-on technical experience (in a laboratory or manufacturing environment) WORKING CONDITIONS & PHYSICAL REQUIREMENTS * Ability to discern audible cues * Ability to ascend or descend ladders, scaffolding, ramps, etc * Ability to stand for prolonged periods of time - up to 60 minutes * Ability to sit for prolonged periods of time - up to 240 minutes * Ability to conduct activities using repetitive motions that include writs, hands and/or fingers * Ability to conduct work that includes moving objects up to 10 pounds To all agencies: Please, no phone calls or emails to any employee of FUJIFILM about this requisition. All resumes submitted by search firms/employment agencies to any employee at FUJIFILM via-email, the internet or in any form and/or method will be deemed the sole property of FUJIFILM, unless such search firms/employment agencies were engaged by FUJIFILM for this requisition and a valid agreement with FUJIFILM is in place. In the event a candidate who was submitted outside of the FUJIFILM agency engagement process is hired, no fee or payment of any kind will be paid. EEO Information Fujifilm is committed to providing equal opportunities in hiring, promotion and advancement, compensation, benefits, and training regardless of nationality, age, gender, sexual orientation or gender identity, race, ethnicity, religion, political creed, ideology, national, or social origin, disability, veteran status, etc. ADA Information If you require reasonable accommodation in completing this application, interviewing, completing any pre-employment testing, or otherwise participating in the employee selection process, please direct your inquiries to our HR Department (FDBN_****************).

The Drug Product and Finished Goods (DPFG) MSAT Intern will help setup the framework and systems of manufacturing process development and bioprocess data at FDBN. 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. Company Overview FUJIFILM Biotechnologies is building the future of bioproduction in Holly Springs, North Carolina. By end of 2025, we'll open North America's largest end-to-end CDMO biopharmaceutical manufacturing facility, offering drug substance production, fill-finish, and packaging under one roof. We're looking for passionate, mission-driven people to help us realize this exciting vision and deliver the next vaccine, cure, or therapy. We offer a dynamic work environment and we're proud to cultivate a culture that will fuel your purpose, energy, and drive-what we call Genki. Ready to shape the future of medicine? Let's transform healthcare together! Holly Springs, North Carolina, combines small-town warmth with proximity to Raleigh's thriving tech scene, making it the perfect blend of community and opportunity. Fujifilm is globally headquartered in Tokyo with over 70,000 employees across four key business segments of healthcare, electronics, business innovation, and imaging. We are guided and united by our Group Purpose of "giving our world more smiles." Visit: *************************************************** Job Description What You'll Do Under the direct supervision, support and guidance of the manager: * Collaborates with experienced engineers on identified project(s). Creates and delivers presentation on identified project to Site Leadership Team at the conclusion of internship.• Builds up understanding of drug product and finished goods processes via daily process monitoring, in process control trending and data analysis • Assists in the optimization of equipment and manufacturing processes • Supports process issues and deviation investigations • Supports the system and logistics for MSAT samples (for process comparability, stability studies and investigation) • Ensures that all work is accurate, precise, properly documented, and compliant with SOPs and FDA cGMP guidelines• Assists MSAT process engineers/experts in supporting drug product and finished goods manufacturing operations, as applicable• Performs other duties, as assigned Basic Requirements * Currently enrolled in an Associate's Degree program with a Life Sciences focus OR• Rising Junior or above and enrolled in an Engineering or Scientific Undergraduate or Master's degree Program• Proficient in Microsoft Word, Excel, and PowerPoint Preferred Requirements * Prior experience in Pharma/Biotech/Chemical Industry is preferred• Prior hands-on technical experience (in a laboratory or manufacturing environment) WORKING CONDITIONS & PHYSICAL REQUIREMENTS * Ability to discern audible cues * Ability to ascend or descend ladders, scaffolding, ramps, etc * Ability to stand for prolonged periods of time - up to 60 minutes * Ability to sit for prolonged periods of time - up to 240 minutes * Ability to conduct activities using repetitive motions that include writs, hands and/or fingers * Ability to conduct work that includes moving objects up to 10 pounds To all agencies: Please, no phone calls or emails to any employee of FUJIFILM about this requisition. All resumes submitted by search firms/employment agencies to any employee at FUJIFILM via-email, the internet or in any form and/or method will be deemed the sole property of FUJIFILM, unless such search firms/employment agencies were engaged by FUJIFILM for this requisition and a valid agreement with FUJIFILM is in place. In the event a candidate who was submitted outside of the FUJIFILM agency engagement process is hired, no fee or payment of any kind will be paid. EEO Information Fujifilm is committed to providing equal opportunities in hiring, promotion and advancement, compensation, benefits, and training regardless of nationality, age, gender, sexual orientation or gender identity, race, ethnicity, religion, political creed, ideology, national, or social origin, disability, veteran status, etc. ADA Information If you require reasonable accommodation in completing this application, interviewing, completing any pre-employment testing, or otherwise participating in the employee selection process, please direct your inquiries to our HR Department (FDBN_****************).

As a team member of the software development team, you will be developing product features from internal and external customer requirements and clinical feedback. Internally known as "Senior Database Administrator." At FUJIFILM Healthcare Americas Corporation, we're on a mission to innovate for a healthier world, and we need passionate, driven people like you to help us get there. Our cutting-edge healthcare solutions span diagnostic imaging, enterprise imaging, endoscopic and surgical imaging, as well as in-vitro diagnostics. But we don't stop at healthcare; our Non-Destructive Testing (NDT) team harnesses advanced radiography solutions to keep transportation infrastructure, aerospace, and oil and gas assets safe and running smoothly. Ready to innovate, collaborate, and make a difference? Join us and bring your big ideas to life while working in a dynamic, flexible environment that fuels your creativity and drive. Our headquarters is in Lexington, Massachusetts, an inspiring healthcare research hub in a historic town. Fujifilm is globally headquartered in Tokyo with over 70,000 employees across four key business segments of healthcare, electronics, business innovation, and imaging. We are guided and united by our Group Purpose of "giving our world more smiles." Visit: *************************************************** Job Description Duties and Responsibilities: * Complete the application of standard database technologies to software design, implementation, and testing. * Working closely with other team members to coordinate assignments and communicate progress and/or difficulties. * Interact with database vendor and support customer site databases as required. * Application of standard database technologies to software design, implementation, and testing. * Interact with database vendor and support customer site databases as required. * Develop Oracle Stored procedures/Functions. * Develop specialized data correction scripts. * Develop mechanisms to resize the database based on customer needs * Investigate Database performance bottlenecks using vendor provided tools * Develop Database installation scripts using SQL, PL/SQL, PowerShell, and windows scripting host. * Develop database automated backup and recovery scripts per database vendor's guidelines. * Develop database upgrade scripts. * Experience with converting Oracle databases to a post GreSQL DB. * Develop mechanisms to ensure that the database meets its high availability goals. * Review Oracle software releases like CPU patches. * Develop Oracle silent installation scripts and integrate with the installation scripts. * Review and implement various Oracle add-on options like Advanced Security, Encryption. * Performing with other duties as assigned. * Comply with all applicable U.S. Food and Drug Administration (U.S. FDA) medical device regulatory requirements, applicable ISO 13485 standard requirements and all other applicable laws, regulations, and standards. Qualifications Essential * BS or BE in Computer Science or related field. * Excellent verbal and written communication skills. * Proven problem-solving skills. * Strong Database development discipline with a keen inclination to database security and maintaining database uptime. * At least 7 years real-world database development experience that must include: * In-depth database design, such as entity relationship modeling * Working and complying within the overall product architecture, with a focus on database performance. * Being a pragmatic team player who can demonstrate initiative. * Having the ability to work independently and meet deadlines. * Expertise in developing software that runs on Windows Server platform (2019, 2022, 2025) using the latest Oracle (12c, 19c, 23ai) database, with a focus on Oracle installation, backup and recovery, High Availability * From a technology perspective, must be: * An expert in Oracle PL/SQL and related Oracle technologies. * Experienced dealing with Oracle Support and resolving time critical issues with various Oracle support tier members. * Experienced in Oracle 19c, 23ai, Active Data Guard, Oracle Real Application Clusters(RAC). * Experienced in identifying and tracking Oracle performance bottlenecks within the application - dbms_monitor, SQL monitoring, AWR, EM, Tkprof. * Experienced in Oracle RMAN backup and recovery, Oracle Universal Installer * Good working knowledge of Oracle options like Advanced Security, Encryption, Compression, etc. * Good knowledge with Database access layers - ODP.NET, SQLNET, Oracle Network and security layers (SSL, etc.) * Familiar with web technologies - Microsoft IIS, nodejs. * Familiar with other development tools - Microsoft VS, TFS * Minimal experience with non-Oracle Database technologies like SQL Server or any open source database like PostGres. Desired * Certified on Oracle products * Nice to have exposure to: * Agile/scrum development. * Non-Oracle technologies - PostGres, Mango, MySQL * Experience with one or more general purpose programming languages including but not limited to: C/C++, C#, JavaScript, HTML, CSS, PL/SQL, SQL Plus * Previous experience in back-end PACS development * Familiar with cloud technology, cloud databases Physical requirements: The position requires the ability to perform the following physical demands and/or have the listed capabilities: * The ability to sit 75-100% of applicable work time. * The ability to use your hands and fingers to feel and manipulate items, including keyboards, up to 100% of applicable work time. * The ability to stand, talk, and hear for 25% of applicable work time. * The ability to lift and carry up to ten pounds up to 20% of applicable work time. * Close Vision: The ability to see clearly at twenty inches or less. Travel: * Occasional (up to 10%) travel may be required based on business need. In the event that COVID-19 vaccine mandates issued by the federal government, or by state or local government become effective and enforceable, the Company will require that the successful candidate hired for positions covered under relevant government vaccine mandate(s) be fully vaccinated against COVID-19, absent being granted an accommodation due to medical or sincerely held religious belief or other legally required exemption. Applicants to positions where vendor credentialing or other similar requirements exist to enter facilities will be required to comply with the credentialing requirements of the facilities, including complying with vaccine requirements. For all positions, the Company encourages vaccination against COVID-19 and requires that the successful candidate hired be willing to test for the COVID-19 virus periodically and wear a face covering indoors as required, absent being granted an accommodation due to medical or sincerely held religious belief or other legally required exemption EEO Information Fujifilm is committed to providing equal opportunities in hiring, promotion and advancement, compensation, benefits, and training regardless of nationality, age, gender, sexual orientation or gender identity, race, ethnicity, religion, political creed, ideology, national, or social origin, disability, veteran status, etc. ADA Information If you require reasonable accommodation in completing this application, interviewing, completing any pre-employment testing, or otherwise participating in the employee selection process, please direct your inquiries to our HR Department (****************************** or ***************.

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. Job Description What You'll Do * Spearheads technical assessments and process design for equipment and facility integration * Develops and executes departmental vision and strategy, overseeing the Engineering Science team * Participates in Request for Proposal (RFP) processes, leading the facility fit assessments, offering technical specifications, feasibility studies, and risk management * Ensures facilities are well-suited for client programs, focusing on technology integration, scalability, and quality assurance * Fosters long-term client relationships by ensuring successful project proposals and executions * Departmental budget adherence * Manages assessments and feasibility studies for prospective new and expanded process equipment and technology capabilities * Responsible for technical leadership in the assessment and process design / fits for new process equipment, facility and operational capabilities needed for new client programs, with focus on Drug Substance Biologics production * Represents Engineering Science as a first point of contact on technical assessments and engineering studies, including technical support for safety assessments * Actively identifies gaps and suggest/drive implementation of improvements of Drug Substance Biologics production and Drug Product manufacturing capability * Performs process simulation to optimize throughput and identify potential bottlenecks * Collaborates with senior internal and external personnel on significant matters often requiring coordination between organizational units * May act or direct team as technical support lead for Process management of safety incidents investigation * Manages and develops direct reports * Administers company policies such as time off, shift work, and inclement weather that directly impact employees * Completes required administrative tasks (e.g., timecard approvals, time off approvals, expense reports etc.) * Coaches and guides direct reports to foster professional development * Participates in the recruitment process and retention strategies to attract and retain talent, as needed * Addresses performance gaps, employee questions and concerns, and partners with HR as needed for resolution * Performs other duties, as assigned Minimum Requirements * Bachelor's degree in Pharmaceutical, Biotech Manufacturing, Engineering or related field with 10+ years of experience; OR * Master's degree in Pharmaceutical, Biotech Manufacturing, Engineering or related field with 8+ years of experience * 6+ years of people management, leadership & team management experience Preferred Requirements * Bachelor's/Master's degree in Biochemical or Chemical Engineering * Direct experience in Large Scale (20KL Cell Culture Scale) Biologics Drug Substance manufacturing Working & Physical Conditions Ability to stand for prolonged periods of time up to 60 minutes.Ability to sit for prolonged periods of time up to 60 minutes. Ability to conduct activities using repetitive motions that include wrists, hands and/or fingers. To all agencies: Please, no phone calls or emails to any employee of FUJIFILM about this requisition. All resumes submitted by search firms/employment agencies to any employee at FUJIFILM via-email, the internet or in any form and/or method will be deemed the sole property of FUJIFILM, unless such search firms/employment agencies were engaged by FUJIFILM for this requisition and a valid agreement with FUJIFILM is in place. In the event a candidate who was submitted outside of the FUJIFILM agency engagement process is hired, no fee or payment of any kind will be paid.

The Senior Specialist 1, Quality Control Technical Transfer(TT) and Sample Support (SS) provides technical support through effective project management of the QC Sample Plans and QC Specifications in close collaboration with relevant stakeholders, including customers. The Sr Specialist 1, TT/SS interfaces with customers to scope QC Sample Plans and QC Specifications. This role participates in collaborations with cross-functional teams as a representative of QC. This role supports the timely completion of project milestones and deliverables. This role supports Good Manufacturing Practices (GMP) compliant laboratory operations in accordance with regulatory guidelines and participates in audits and inspections. Company Overview FUJIFILM Biotechnologies is building the future of bioproduction in Holly Springs, North Carolina. By end of 2025, we'll open North America's largest end-to-end CDMO biopharmaceutical manufacturing facility, offering drug substance production, fill-finish, and packaging under one roof. We're looking for passionate, mission-driven people to help us realize this exciting vision and deliver the next vaccine, cure, or therapy. We offer a dynamic work environment and we're proud to cultivate a culture that will fuel your purpose, energy, and drive-what we call Genki. Ready to shape the future of medicine? Let's transform healthcare together! Holly Springs, North Carolina, combines small-town warmth with proximity to Raleigh's thriving tech scene, making it the perfect blend of community and opportunity. Fujifilm is globally headquartered in Tokyo with over 70,000 employees across four key business segments of healthcare, electronics, business innovation, and imaging. We are guided and united by our Group Purpose of "giving our world more smiles." Visit: *************************************************** Job Description Responsibilities: * Collaborates with customers and stakeholders from QC and DS Manufacturing (DSM) to support tech transfers of new customer projects as they relate to QC Sample Plans and DS/DP Specifications * Participates in updates of controlled GMP documents related to QC Sample Plans and QC Specifications * Participates in writing and review of change controls of QC Sample Plans for both internal and external changes together with relevant stakeholders, including communication with customers as applicable * Manages continuous improvement of QC Sample Plans and QC Specifications as needed * Applies holistic quality system approach through identifying and solving technical and compliance gaps. * Identifies areas for improvement or remediation related to quality or process and leads through completion and sustainable implementation * Participates in team compliance activities including writing, changing, and maintaining GMP documents in collaboration with relevant stakeholders and QA * Ensures compliance with platform, procedures, and global QC vision. Supports management in training compliance with policies and inspections. Supports regulatory requests, audits, and inspections * Collaborates with the LIMS team and IT department to build DS/DP sample plan and specification functions that meet end-user and customer requirements * Performs other duties as assigned Required Skills: * Excellent verbal and written communication skills and attention to detail * Ability to lead improvement projects * Ability to analyze and present data and technical information to others outside of the team * Ability to solve complex challenges and assist others as needed * Ability to think strategically, plan, and implement improvements * Primary contact for clients in the laboratory and eagerness for enhancing customer satisfaction * Self-driven and dedicated with excellent time management skills * Flexible with a positive attitude and positive energy; seeks challenges and opportunities * Ability to work cross-functionally with a diverse team * Must be flexible to support 24/7 manufacturing facility Education/Experience Required: * Bachelors in Biological Sciences, Engineering, or related science field with 2+ years of relevant experience OR * Masters in Biological Sciences, Engineering, or related science field with 0 years of relevant experience * Prior experience with project management in biotechnology, Pharma, Contract Research Organization (CRO), or Contract Laboratory Organization (CLO) * 1-3 years' experience in a GMP environment. * Prior experience in leading technical writing initiatives. Education/Experience Preferred: * Masters in Biological Sciences, Engineering, or related science field with 1 year of relevant experience * Experience with Customer Relationship Management * Prior drug substance or manufacturing experience, including process validation, transfer, commercialization, and manufacturing support and troubleshooting. * Experience using quality systems (e.g., deviation management system, change control, corrective and preventive action (CAPA), document management system) * Prior experience in participating in project improvement management. * LEAN/6S certification Physical Requirements/Working Environment: * Ability to discern audible cues. * Ability to inspect or perform a task with 20/20 corrected vision, visual acuity, including distinguishing color. * Ability to ascend or descend ladders, scaffolding, ramps, etc. * Ability to stand for prolonged periods of time up to 60 minutes. * Ability to sit for prolonged periods of time up to 60 minutes. * Ability to conduct activities using repetitive motions that include writs, hands and/or fingers. * Ability to conduct work that includes moving objects up to 10 pounds. * Ability to bend, push or pull, reach to retrieve materials from 18" to 60" in height, and use twisting motions. * Will work in small and/or enclosed spaces. * Will work in heights greater than 4 feet. To all agencies: Please, no phone calls or emails to any employee of FUJIFILM about this requisition. All resumes submitted by search firms/employment agencies to any employee at FUJIFILM via-email, the internet or in any form and/or method will be deemed the sole property of FUJIFILM, unless such search firms/employment agencies were engaged by FUJIFILM for this requisition and a valid agreement with FUJIFILM is in place. In the event a candidate who was submitted outside of the FUJIFILM agency engagement process is hired, no fee or payment of any kind will be paid. * #LI-Onsite EEO Information Fujifilm is committed to providing equal opportunities in hiring, promotion and advancement, compensation, benefits, and training regardless of nationality, age, gender, sexual orientation or gender identity, race, ethnicity, religion, political creed, ideology, national, or social origin, disability, veteran status, etc. ADA Information If you require reasonable accommodation in completing this application, interviewing, completing any pre-employment testing, or otherwise participating in the employee selection process, please direct your inquiries to our HR Department (FDBN_****************).