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FUJIFILM Diosynth Biotechnologies jobs in Holly Springs, NC - 93 jobs

  • Investigator 2

    Fujifilm Diosynth Biotechnologies 4.0company rating

    Fujifilm Diosynth Biotechnologies job in Holly Springs, NC

    The Investigator 2 is responsible to perform major investigations, identify root and contributing causes, contributes to the creation of effective corrective and preventative actions (CAPA) while ensuring timely closure of assigned investigations. This role also supports senior investigators with complex investigations as needed and provides guidance to junior investigators. 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 Project Phase (Through Mid-2026) * Authors standard operating procedures (SOPs) and work instructions (WIs) to support operational readiness, as needed• Performs "in operations" duties listed below as required prior to routine operations Operations (Starting Mid-2026) * Completes major internal manufacturing investigations to support DSM• Supports senior investigators with complex investigations, as needed• Applies systematic casual analysis methods to identify root and contributing cases for assigned investigations• Documents clear and concise investigation findings and related actions in alignment with Quality Management System requirements• Communicates investigation process to impacted areas, including management, and tracks milestones throughout the investigations• Partners with key stakeholders during the development of CAPAs to support the investigation process• Manages investigation workload to ensure closure of investigations within required timeline• Supports senior investigators during assignment of workload for DSM Deviations Management team, as needed• Contributes to metric reports to prepare presentations for senior leadership• Delivers informative and engaging presentations regarding metrics and other relevant information to required stakeholders, as needed• Provides guidance to junior investigators regarding investigative techniques and best practices• Other duties, as assigned Basic Requirements * High School Diploma/GED with 9 years of related experience (e.g., investigations); OR• Associate's degree in Life Sciences or Engineering with 7 years of related experience (e.g., investigations); OR• Bachelor's degree in Life Sciences or Engineering with 5 years of related experience (e.g., investigations); OR• Equivalent Military experience• Experience in quality or manufacturing operations• Prior experience leading manufacturing investigations Preferred Requirements * Experience with systematic cause analysis methods (e.g., Event & Casual Factor Analysis, Logic Fault Tree, or similar techniques) * Root Cause Analysis (RCA) training WORKING CONDITIONS & PHYSICAL REQUIREMENTS * Will work in environment operating a motor vehicle or Powered Industrial Truck * Ability to discern audible cues * Ability to stand for prolonged periods of time * Ability to sit for prolonged periods of time * 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_****************).
    $97k-146k yearly est. Auto-Apply 60d+ ago
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  • Warehouse Associate 2/ Material Handler level 2

    Fujifilm Diosynth Biotechnologies 4.0company rating

    Fujifilm Diosynth Biotechnologies job in Holly Springs, NC

    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.
    $32k-37k yearly est. Auto-Apply 41d ago
  • Director, QA Drug Substance Operations

    Fujifilm Diosynth Biotechnologies 4.0company rating

    Fujifilm Diosynth Biotechnologies job in Holly Springs, NC

    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_****************).
    $114k-141k yearly est. Auto-Apply 32d ago
  • Internal Event Planner, NC Region

    Fujifilm Diosynth Biotechnologies 4.0company rating

    Fujifilm Diosynth Biotechnologies job in Holly Springs, NC

    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_****************).
    $68k-83k yearly est. Auto-Apply 14d ago
  • Intern, QA Operations DSM

    Fujifilm Diosynth Biotechnologies 4.0company rating

    Fujifilm Diosynth Biotechnologies job in Holly Springs, NC

    The QA Intern is responsible to assist in the Quality oversight of Drug Substance Manufacturing and supporting areas, bridging from site project/startup phase to operational readiness. The QA Intern collaborates within the Drug Substance Quality Operations team as well as with other project teams on site with a focus on consistent policy administration, QA oversight of day-to-day activities and resolution or mitigation of issues occurring during operation. 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: * Supports QA for specific tasks and deliverables within the assigned Quality area * Participates in streamlining and standardizing day to day quality related risks * Maintain detailed schedules via Smartsheet, electronic and physical dashboards, and PowerPoint presentations as applicable * Prepare and coordinate optimization of deliverables with other cross-functional stakeholders and internal customers. * Accomplish assigned intern project tasks on agreed timelines * Design/maintain a communication strategy to provide schedule, task, and status updates to the impacted teams. * 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 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_****************).
    $51k-64k yearly est. Auto-Apply 16h ago
  • Supervisor, Manufacturing Support

    Fujifilm Diosynth Biotechnologies 4.0company rating

    Fujifilm Diosynth Biotechnologies job in Holly Springs, NC

    The Supervisor, Manufacturing Support is responsible for leading the material, training and production scheduling teams within manufacturing support and their associated activities to ensure compliant and reliable production. 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 During the project phase * Provides oversight and leads operational readiness projects including but not limited to leading the creation or transfer, from existing large-scale facility, manufacturing support team business processes to ensure good manufacturing practice (GMP) operational readiness• Leads and builds the process support team through project phase activities• 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.)• Other duties, as assigned In operations * Manages and develops direct reports from support manufacturing team • Oversees and coordinates the tasks of providing materials, training, and production schedule support to manufacturing• 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.)• Oversees the coordination of manufacturing activities (e.g., campaign materials, Kanban, vendor management inventory support, training and curriculum, detailed batch schedules, short flow investigations, and alert and action limits)• Manages manufacturing change controls and corrective and preventive actions (CAPAs)• Ensures continuous improvement, drives escalation and mitigates manufacturing issues• Supports and acts as a secondary lead for regulatory inspection and audits• 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• Other duties, as assigned Basic Requirements * High School diploma/GED with 6 years related experience; OR• Bachelor's Degree in Life Science, Engineering, or related field with 2 years of related experience; OR• Master's Degree in Life Science, Engineering, or related field with no prior experience• Experience directly supporting manufacturing• Experience with regulatory inspections, investigations and change management Preferred Requirements * Experience in pharmaceutical or biological manufacturing operations• Experience leading others in a pharmaceutical or biological manufacturing facility• Experience working in a changing environment within a project driven organization * Lean certification or similar certifications WORKING CONDITIONS & PHYSICAL REQUIREMENTS * Ability to discern audible cues * Ability to stand for prolonged periods of time * Ability to sit for prolonged periods of time * Ability to operate machinery and/or power tools * Ability to conduct work that includes moving objects up to 10 pounds * Will work in warm/cold environments * Will work in outdoor elements such as precipitation and wind 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_****************).
    $95k-116k yearly est. Auto-Apply 40d ago
  • Intern, Sustainability

    Fujifilm Diosynth Biotechnologies 4.0company rating

    Fujifilm Diosynth Biotechnologies job in Holly Springs, NC

    Interested in making a difference in the world and influencing the long-term environmental impact of a $2 Billion-dollar mega pharmaceutical project striving to be THE most sustainable biopharmaceutical CDMO in the US? Fujifilm Diosynth Biotechnologies is offering a Sustainability internship for college students majoring in Environmental, Health, Safety, Sustainability or Engineering. This position will reside within the EHS and Sustainability Department and report to the Head of EHS and Sustainability. This unique opportunity will interface with industry leading professionals from both Fujifilm and our global engineering partners to provide direct support in the development and execution of sustainability initiatives across the areas of carbon neutrality, water minimization, zero to landfill, green buildings, and low impact development. Specific focus areas will include support of life cycle impact modelling (carbon, energy, water, biodiversity), research of industry best practices and development of business cases for integration into the program. In addition, this role will support development of a portfolio of industry best practices that will be leveraged for integration in future expansion projects around the world. You will gain real-world, hands-on experience with some of the top professionals in the world. You will be exposed to cutting edge technologies and a culture of caring. You will be given the freedom to explore innovative opportunities which have yet to be implemented in the US. This role requires out of the box thinking, development of concepts into viable solution and ability to present complex concepts to a diverse audience. Are you ready for the opportunity of your life that could kickstart your career? 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 * Support LEED execution team to ensure Gold Certification process requirements are met * Investigate opportunities to minimize traffic impact during construction and into operations * Collaborate with architectural team to ensure alignment to Fit-Well/Well criterial through design * Assess prospective chemicals and impacts to wastewater discharge through treatability/environmental fate analysis 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 with a Environmental, Health, Safety, or Sustainability focus• 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_****************).
    $67k-89k yearly est. Auto-Apply 3d ago
  • Supervisor, Maintenance

    Fujifilm Diosynth Biotechnologies 4.0company rating

    Fujifilm Diosynth Biotechnologies job in Holly Springs, NC

    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!
    $85k-104k yearly est. Auto-Apply 32d ago
  • Intern, MSAT Lab

    Fujifilm Diosynth Biotechnologies 4.0company rating

    Fujifilm Diosynth Biotechnologies job in Holly Springs, NC

    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_****************).
    $27k-36k yearly est. Auto-Apply 6d ago
  • Intern, Program Management

    Fujifilm Diosynth Biotechnologies 4.0company rating

    Fujifilm Diosynth Biotechnologies job in Holly Springs, NC

    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_****************).
    $33k-40k yearly est. Auto-Apply 6d ago
  • Intern, Health & Safety

    Fujifilm Diosynth Biotechnologies 4.0company rating

    Fujifilm Diosynth Biotechnologies job in Holly Springs, NC

    Interested in making a difference in the world and influencing the long-term environmental impact of a $2 Billion-dollar mega pharmaceutical project striving to be THE most sustainable biopharmaceutical CDMO in the US? Fujifilm Diosynth Biotechnologies is offering a Health and Safety internship for college students majoring in Environmental, Health, Safety, Sustainability or Engineering. This position will reside within the EHS and Sustainability Department and report to the Head of EHS and Sustainability. This unique opportunity will interface with industry leading professionals from both Fujifilm and our global engineering partners to provide direct support in the development and execution of safety initiatives across the areas of design, construction, start-up and operations. Specific focus areas will include use of predictive leading indicators to minimize risk of injury, 3D design reviews and development of operational programs. You will gain real-world, hands-on experience with some of the top professionals in the world. You will be exposed to cutting edge technologies and a culture of caring. You will be given the freedom to explore innovative opportunities which have yet to be implemented in the US. This role requires out of the box thinking, development of concepts into viable solution and ability to present complex concepts to a diverse audience. Are you ready for the opportunity of your life that could kickstart your career? 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 * Support of Black Belt project focused on use of predictive, leading indicators to minimize risk of serious injury * Develop operational Health and Safety standard operating procedures including confined space, lockout\tagout, fall protection, etc * Conduct field inspections and corrective action closure 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 with a Environmental, Health, Safety, or Sustainability focus• 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_****************).
    $27k-33k yearly est. Auto-Apply 3d ago
  • Sr. Oncology Sales Representative - Knoxville, TN

    Merck 4.6company rating

    Raleigh, NC job

    Our Sales team support our customers by providing clinical information about products, educational information, clinical training programs and resources. We support healthcare providers and healthcare systems meet the goals of the patients in their communities. Our Company's Oncology organization is dedicated to delivering breakthrough innovations that extend and improve the lives of cancer patients worldwide. Our team of dauntless, forward-thinking individuals achieves this through an unwavering commitment to supporting accessibility to medicine, providing new therapeutic procedures, and collaborating with governments and payers to ensure that people who need medicines have access to them. At our company, our focus is on innovation and launch execution excellence; we translate breakthrough science into innovative medicines that help people with cancer across the globe. As we continue to grow and define the Oncology market of the future, we are looking for dynamic, entrepreneurial individuals who thrive in a team environment and are driven to succeed. The Oncology Sales Specialist is a key member of our customer facing organization and is responsible for partnering with customers to address identified needs, educating key stakeholders about our leading immunotherapy compound, and communicating our vision to the larger Oncology community. + This is a field based sales position that will cover the **Knoxville, TN** territory. **This territory also includes Chattanooga, TN** . + The selected candidate must reside within the territory. + Overnight travel may be required about 25% of the time. + Travel (%) varies based on candidate's location within the geography. **General Responsibilities:** + Demonstrate in-depth knowledge of how to create a compelling and logical rationale for the value of products and how to contrast, compare, and position our company brand(s) versus competition using appropriate resources in informed discussions about products with HCP customers - knowing when/how to seek and provide additional information + Act as primary point of contact for customer. Meet with key customers/personnel to understand practice structure, business model, and key influencers. + Possess knowledge of cancer staging and possible treatment options and dosing schedules associated with different tumors/diseases, with comprehensive understanding of the impact of those options on the patient. Must understand impact and use of clinical trials in multiple tumor types/therapies, both in impact on promoted products and in practice behavior of the account. + Ability to analyze and identify trends in a complex buying environment. This includes the multiple channels of drug distribution, Oncology GPO's, wholesalers and specialty pharmacies. Review and evaluate patterns for products purchased and prescribed, outpatient vs in-patient infusion, as part of hospital contract, etc. + Demonstrate ability to understand complex account interdependencies in order to develop both short- and long-term account plans in conjunction with a wide array of stakeholders, proactively working with the account team and supervisor (known as the Customer Team Leader) to effectively execute the account plan. Share learnings and best-practices from one customer to help other customers meet their needs. + Influence beyond their specific geography or product area demonstrate advanced ability to ask strategic, insightful questions to obtain information on customer needs from all stakeholders in oncology accounts, using the insights to position our company Oncology brands and collaborate with customers on a customized strategy. + Collaborate and communicate effectively with extended "in-scope" customer team to ensure a consistent customer experience across our company's divisions and functional areas; ensure integration with the Key Account Manager, Nurse Educator, Field Reimbursement Associate, Medicare Account Executive, and other key stakeholders to share key customer learnings and support customer needs. **Position Qualifications** **:** **Minimum Requirements:** + Bachelor's degree with 6-8 years Sales experience OR a minimum of high school diploma with at least 10 years of equivalent experience + Equivalent experience can be: Professional sales experience, work experience in the healthcare/scientific field (including pharmaceutical, biotech, or medical devices) that is not sales related, professional marketing experience, or military experience + 2+ years of oncology field sales experience + Valid driver's license and ability to drive a motor vehicle + Travel the amount of time the role requires **Preferred Experience and Skills:** + Documented history of strong performance in a sales / marketing or oncology clinical role + Clinical oncology experience across multiple solid tumors (Women's cancer - Breast, Ovarian, and Cervical) MSJR oncosales **Required Skills:** Account Management, Account Management, Account Planning, Adaptability, Biodesign, Biopharmaceutical Industry, Cancer Diagnosis, Clinical Experience, Customer-Focused, Customer Handling, Customer Service, Digital Analytics, Healthcare Innovation, Healthcare Sales, Interpersonal Relationships, IS Audit, Lead Generation, Lead Generation Management, Market Access, Market Analysis, Medical Devices, Oncology Sales, Pharmacology, Product Knowledge, Proven Commitment {+ 5 more} **Preferred Skills:** Current Employees apply HERE (***************************************************** Current Contingent Workers apply HERE (***************************************************** **US and Puerto Rico Residents Only:** Our company is committed to inclusion, ensuring that candidates can engage in a hiring process that exhibits their true capabilities. Please click here (*************************************** if you need an accommodation during the application or hiring process. As an Equal Employment Opportunity Employer, we provide equal opportunities to all employees and applicants for employment and prohibit discrimination on the basis of race, color, age, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or other applicable legally protected characteristics. As a federal contractor, we comply with all affirmative action requirements for protected veterans and individuals with disabilities. For more information about personal rights under the U.S. Equal Opportunity Employment laws, visit: EEOC Know Your Rights (****************************************************************************************** EEOC GINA Supplement We are proud to be a company that embraces the value of bringing together, talented, and committed people with diverse experiences, perspectives, skills and backgrounds. The fastest way to breakthrough innovation is when people with diverse ideas, broad experiences, backgrounds, and skills come together in an inclusive environment. We encourage our colleagues to respectfully challenge one another's thinking and approach problems collectively. Learn more about your rights, including under California, Colorado and other US State Acts (********************************************** **U.S. Hybrid Work Model** Effective September 5, 2023, employees in office-based positions in the U.S. will be working a Hybrid work consisting of three total days on-site per week, Monday - Thursday, although the specific days may vary by site or organization, with Friday designated as a remote-working day, unless business critical tasks require an on-site presence.This Hybrid work model does not apply to, and daily in-person attendance is required for, field-based positions; facility-based, manufacturing-based, or research-based positions where the work to be performed is located at a Company site; positions covered by a collective-bargaining agreement (unless the agreement provides for hybrid work); or any other position for which the Company has determined the job requirements cannot be reasonably met working remotely. Please note, this Hybrid work model guidance also does not apply to roles that have been designated as "remote". The salary range for this role is $156,900.00 - $247,000.00 This is the lowest to highest salary we in good faith believe we would pay for this role at the time of this posting. An employee's position within the salary range will be based on several factors including, but not limited to relevant education, qualifications, certifications, experience, skills, geographic location, government requirements, and business or organizational needs. The successful candidate will be eligible for annual bonus and long-term incentive, if applicable. We offer a comprehensive package of benefits. Available benefits include medical, dental, vision healthcare and other insurance benefits (for employee and family), retirement benefits, including 401(k), paid holidays, vacation, and compassionate and sick days. More information about benefits is available at ****************************************************** . You can apply for this role through **************************** (or via the Workday Jobs Hub if you are a current employee). The application deadline for this position is stated on this posting. **San Francisco Residents Only:** We will consider qualified applicants with arrest and conviction records for employment in compliance with the San Francisco Fair Chance Ordinance **Los Angeles Residents Only:** We will consider for employment all qualified applicants, including those with criminal histories, in a manner consistent with the requirements of applicable state and local laws, including the City of Los Angeles' Fair Chance Initiative for Hiring Ordinance **Search Firm Representatives Please Read Carefully** Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails. **Employee Status:** Regular **Relocation:** No relocation **VISA Sponsorship:** No **Travel Requirements:** 25% **Flexible Work Arrangements:** Remote **Shift:** Not Indicated **Valid Driving License:** Yes **Hazardous Material(s):** N/A **Job Posting End Date:** 01/17/2026 ***A job posting is effective until 11:59:59PM on the day** **BEFORE** **the listed job posting end date. Please ensure you apply to a job posting no later than the day** **BEFORE** **the job posting end date.** **Requisition ID:** R379851
    $156.9k-247k yearly 6d ago
  • Engineer 2, Material Science

    Fujifilm Diosynth Biotechnologies 4.0company rating

    Fujifilm Diosynth Biotechnologies job in Holly Springs, NC

    The Engineer or Scientist 2, Material Science supports the design of new single-use consumables in conjunction with our manufacturing teams. This role assists the leachable and extractables program, that includes facilitation of testing based on products evaluated. This role also supports manufacturing investigations involving material science (e.g., raw material variability and concerns, consumable issues and particle sources). The role writes investigation reports and leachable and extractable reports. Job Description What You'll Do * Supports the team with the introduction of new raw materials, and associated document requirements * Assesses vendor change notifications, and provides input on raw materials related matters * Supports change requests for introduction, modification, and discontinuation of raw materials * Provides support between Quality Control (QC), Supply Chain, Manufacturing, and Quality to assess material and supplier risks (e.g., supplier technical evaluations, risk assessments, raw material evaluation and qualification, and new product introductions) * Support troubleshooting, process impact assessments, and facilitation of root cause analysis (RCA) and corrective and preventive action (CAPA) in response to critical deviations related to materials used in manufacturing, as needed * Delivers documentation for internal and external use, such as comprehensive written protocols and reports, summarizing investigations and impact assessments, studies and projects * Supports process sub-teams throughout the phases of technology transfer (TT) * Supports TT stage gate reviews on incoming processes and manufacturing readiness (e.g., acceptable process material evaluations, risk assessments, mitigation, and robust supporting data for the proposed changes) * Provides comprehensive written manufacturing reports summarizing investigations, studies and projects * Supports generation of sampling plans for process validation reports (PVRs) and investigations * Collaborates with the Manufacturing department to support commercial and clinical manufacturing campaigns, investigate materials issues, and implement necessary changes * Assists continuous improvement projects, in partnership with Manufacturing, Quality, Engineering, and global teams to improve manufacturability, reliability, yield and cost * Assists in solutions in selecting methods, evaluating, adapting of complex techniques to obtaining results consistent with departmental objectives * Other duties, as assigned Knowledge and Skills * Builds connections with key contacts within the department and outside specialty * Communicates effectively within the team * Engages in important conversations with cross-functional team members * Develops basic hypotheses for projects * Possesses fundamental project management skills. Effectively communicates information to others * Thinks critically and self-directed with minimal oversight * Understands basic project management and quality systems (e.g., Change Control, document management system) * Strong communication and teamwork skills * Solid grasp of material investigation methods Stays informed about regulatory and quality requirements in manufacturing * Knowledgeable of material investigation principles and techniques Basic Requirements * Bachelor's degree in Engineering, Life Science or Chemical Engineering with 2 years of applicable industry experience; OR * Master's degree in Engineering, Life Science or Chemical Engineering with no relevant experience * Experience working in a Good Manufacturing Practices (GMP) environment Preferred Requirements * Prior drug substance or manufacturing experience, including process validation, transfer and commercialization, and manufacturing support and troubleshooting * Experience supporting the following:o Writing portions of regulatory filings and regulatory auditso New product launches and validation of processo Global or multi-site validation programs WORKING CONDITIONS & PHYSICAL REQUIREMENTS * Ability to discern audible cues. 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.
    $81k-103k yearly est. Auto-Apply 3d ago
  • Intern, Supply Chain Operations

    Fujifilm Diosynth Biotechnologies 4.0company rating

    Fujifilm Diosynth Biotechnologies job in Holly Springs, NC

    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_****************).
    $76k-95k yearly est. Auto-Apply 6d ago
  • Raw Material Sampler 3

    Fujifilm Diosynth Biotechnologies 4.0company rating

    Fujifilm Diosynth Biotechnologies job in Holly Springs, NC

    The Raw Material Sampler 3 position is responsible for sampling of materials and products at the Holly Springs FDBN large scale manufacturing facility, which produces Drug Substance (DS), Drug Product (DP), and Finished Goods (FG) products. This role works with multiple functions to support operations: Warehouse, Supply Chain, Quality Control (QC), and other customers, as needed. The Raw Material Sampler 3 uses Systems and Applications Production (SAP) Enterprise Resource Planning (ERP) system for inventory management and Laboratory Information Management System (LIMS) for sample management while operating in a good manufacturing practice (GMP) facility with standard operating procedures (SOPs). 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 Project Phase:•Assists in the preparation for operational readiness including but not limited to creating and implementing new SOPs, development or transfer of warehouse business processes, testing and commissioning support with validation, and start-up activities with SAP ERP•Completes interim responsibilities (e.g., attending Integrated Working Team (IWT) meetings, owning IWT milestones, ordering supplies and owner equipment, supporting CQV activities) for operational readiness at the FDBN large scale greenfield site•Travels up to 25% (international or domestic) Operations:•Transfers materials into and out of Raw Material Sampling using powered or manual industrial trucks (PIT)•Performs Grade D gowning and material transfers•Performs sampling operations per material specifications•Interfaces with Warehouse, supervision, Supply Chain and QC•Identifies issues and suggests resolutions•Uses analytical and bench top scales in sampling booths•Interfaces with warehouse and supervision•Identifies issues operations, equipment, systems, procedures, and initiates corrective action for resolution•Executes cycle counting material in Raw Material Sampling•Identifies and maintains inventory levels for efficient sample throughput and scheduling•Troubleshoots inventory discrepancies•Trains lower-level associates on Raw Material Sampling operations•Leads department GEMBA and safety walks•Fills in for Lead Associate, as needed•Acts as the Subject Matter Expert (SME) for Raw Material Sampling operations, as defined by leadership•Leads departmental continuous improvement efforts, as directed•Other duties, as assigned Knowledge, Skills * Ability to use respiratory and required PPE for dispensing•Knowledge of GMP and good distribution practice (GDP)•Intermediate knowledge of SAP material transactions and reports•Intermediate knowledge of LIMS and sample management•Intermediate understanding of cold chain and hazardous material handling•Knowledge of ERP for ordering and receiving warehouse materials•Intermediate understanding of sampling specifications• Ability to work shift work or weekend hours to support 24/7 operations and/or required to fulfill on-call responsibilities, as needed Basic Requirements * High School Diploma or GED with 6 years related experience in a manufacturing environment; or•Associate's Degree in Life Sciences or similar area with 4 years of related experience in a manufacturing environment; or•Bachelor's Degree with 2 years related experience in a manufacturing environment or Military experience of equivalence•Experience with analytical and bench top scales * Previous weigh and dispense or raw material sampling experience Preferred Requirements * Prior experience operating industrial trucks•Experience with ERPs and LIMS, SAP and Labware•Previous GMP experience in a QC or sampling role•Experience training other associates * Bioworks or BTEC Capstone cGMP coursework WORKING CONDITIONS & PHYSICAL REQUIREMENTS * Will work in environment which may necessitate respiratory protection * 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 * Ability to sit for prolonged periods of time * 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 outdoor elements such as precipitation and wind 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_****************).
    $74k-104k yearly est. Auto-Apply 54d ago
  • Sr Analyst 1, QC Microbiology

    Fujifilm Diosynth Biotechnologies 4.0company rating

    Fujifilm Diosynth Biotechnologies job in Holly Springs, NC

    The Sr. Analyst 1, QC Microbiology is responsible for leading key operational aspects of the QC Microbiology laboratory. The Sr. Analyst 1, QC Microbiology performs and trains other team members on the microbial testing of all in-process drug substance, drug product, EM/UM, and raw materials samples. This role is responsible for all activities associated with testing in accordance with written procedures. This role primarily works independently with minimal supervision as needed, consults with management on key decisions. 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 About This Role * Executes advanced lab testing and support for all laboratory assays for all samples, and acts as a Subject Matter Expert (SME) and qualified trainer of at least one test * Leads sample collection and manages sample logistics for testing * Supports testing for all qualification and study directed testing * Supports investigation of routine OOS assays and events * Conducts qualification and validation protocols * Leads sterility testing * Reviews intermediate lab testing results * Troubleshoots complex assays * Writes and assists with document preparation and review * Manages project timelines * Assists management with training and on-boarding of new staff as needed * Embraces LEAN lab and six sigma principles and applies them to laboratory processes * Champions projects and project management as assigned * Performs other duties, as assigned Minimum Qualifications * Bachelor's with 2+ years of relevant Microbiology experience OR * Master's with 0 years of experience • Experience with aseptic production & support * 1-3 years in a GMP environment • Advanced understanding of GMP, GLP, GDP requirements * Advanced knowledge in Microbiology theory * Advanced knowledge of Microbiology testing and laboratory experience * LIMS experience * Experience with document control including reviewing and editing technical documents * LEAN lab and Six Sigma training and/or certification * Intermediate familiarity with fundamental statistical tools to analyze data in relation to trends results * Intermediate LIMS software training * Knowledge or training of FDA regulations (cGMP, cGLP, cGDP) Preferred Qualifications * Master's with 1+ years of experience * 4+ years of previous experience working within QC Microbiology or with GXP or quality systems is an advantage * Advanced experience in a GMP QC Microbiology Laboratory, advanced knowledge of all compendial test methods (Bioburden, Endotoxin, Sterility testing) * Advanced experience with microbial ID systems, ability to troubleshoot complex equipment and instrumentation (MALDI, MicroSeq) * Advanced LIMS / Trackwise software training * Experience working within a QC laboratory environment, commissioning Pharmaceutical and/or laboratory facilities WORKING CONDITIONS & PHYSICAL REQUIREMENTS PHYSICAL REQUIREMENTS PHYSICAL DEMANDS 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 WORKING ENVIRONMENT PHYSICAL DEMANDS Ability to ascend or descend ladders, scaffolding, ramps, etc. No X 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 ENVIRONMENTAL CONDITIONS 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 * ---- FDBN is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability, protected veteran status, sexual orientation, gender identify or any other protected class. If an accommodation to the application process is needed, please email FDBN_****************. 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_****************).
    $103k-124k yearly est. Auto-Apply 14d ago
  • Senior Database Administrator / Developer

    Fujifilm Diosynth Biotechnologies 4.0company rating

    Fujifilm Diosynth Biotechnologies job in Durham, NC

    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 ***************.
    $100k-120k yearly est. Auto-Apply 42d ago
  • Intern, Finance

    Fujifilm Diosynth Biotechnologies 4.0company rating

    Fujifilm Diosynth Biotechnologies job in Holly Springs, NC

    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_****************).
    $51k-65k yearly est. Auto-Apply 6d ago
  • Engineer 1/2, Clean Utilities

    Fujifilm Diosynth Biotechnologies 4.0company rating

    Fujifilm Diosynth Biotechnologies job in Holly Springs, NC

    The Clean Utilities Engineer provides engineering support to field personnel in the performance of maintenance and operational tasks associated with Clean Utilities, including reverse osmosis/electrodeionization (RO/EDI) skids, water for injection (WFI), purified water (WPU), Clean gasses and applicable waste systems. This role works directly with other Utility Engineers ensuring applicable safety and regulatory standards are maintained, identifies process improvements, and assists with troubleshooting equipment issues to maintain overall plant reliability. Additional responsibilities includes supporting deviation investigations and documentation for associated system deficiencies. Job Description What You'll Do * Coordinates with Senior Utility Engineers within assigned discipline to ensure project deliverables (e.g., specification review, Factory Acceptance Tests (FATs) and visits, equipment installation, and issue resolution) are performed to the company standards•Assists in the development of Project Change Controls (PCCs) to document specific changes to the design of systems within assigned discipline•Assists with deviations and change control resolutions and closures, as needed•Under the direction of a Senior Engineer or manager, performs reviews of submittals, installation, and testing of equipment within assigned discipline across all buildings on site•Assists other engineers with field walkdowns with Utility Engineering and Construction personnel to ensure systems are installed per approved standards and drawings•Provides routine engineering technical support for all plant utilities and systems (e.g., plant steam boilers, cooling systems, compressed air, etc.), as needed•Partners with other Engineers to review and approve Preventative Maintenance templates for equipment within assigned discipline•Collaborates with Utility Operators and Maintenance Technicians to resolve operational issues•Supports other engineers in the development of User Requirement Specs, Standard Operating Procedures (SOPs) and equipment maintenance and troubleshooting•Provides support for the implementation of maintenance strategies to maximize equipment reliability in conjunction with Senior Engineers•Performs simple troubleshooting for equipment challenges•Collaborates with other departments (e.g., Utility Operations, Maintenance, Facilities, Environmental Health, and Safety)•Other duties, as assigned Knowledge & Skills * Effective communication, both written and verbal•Proficient in Microsoft Office (e.g., Word, Excel, PowerPoint, SharePoint)•Ability to utilize other software programs related to job responsibilities•Ability to analyze and troubleshoot system and component related issues•Ability to effectively present information to others Required Skills * Bachelor's Degree in Engineering with 0-1 years of experience with process utility related components and systems Preferred Skills * Bachelor's Degree in Engineering with 2 years of experience with process utility related components and systems * Experience working in a Good Manufacturing Practices (GMP) or other highly regulated environment Working Conditions & Physical Requirements:PHYSICAL 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 X YesAbility 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 30 minutes Ability to sit for prolonged periods of time. No X Yes 120 minutes Ability to conduct activities using repetitive motions that include writs, hands and/or fingers. X No YesAbility to operate machinery and/or power tools. X No 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. X No Yes 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
    $68k-106k yearly est. Auto-Apply 32d ago
  • Intern: DPFG MSAT Process Engineer

    Fujifilm Diosynth Biotechnologies 4.0company rating

    Fujifilm Diosynth Biotechnologies job in Holly Springs, NC

    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_****************).
    $35k-45k yearly est. Auto-Apply 21d ago

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