8 jobs found in holly springs

Overview The Head of Process Science will establish and lead our Manufacturing Science, Program Management & Tech Transfer interfaces to drug development partners at our Holly Springs site.  This senior leader will be essential in driving our new customer base as well as ensuring complete end-to-end Process Development and Manufacturing Science as Drug Product capabilities are being built to form an entire Process Science team.  They will function as the key overall customer interface for new products, processes and changes from partners and programs.  All strategic, tactical and operational aspects of the group will support the bulk drug substances and ensure close collaboration with Manufacturing, Global Engineering & Facilities, Quality, Regulatory, CMC, Business Development and Tech Development in meeting the business objectives.  The Head of Process Science will collaborate closely with our Denmark location to ensure alignment across key areas and will...

Overview We are looking for a site senior leadership team member who will join as Head of Product Supply on our journey to establish the largest end-to-end cell culture CDMO facility in North America. As Head of Product Supply, you will be responsible for Drugs Substance Manufacturing, Drug Product & Finished Goods Manufacturing and Supply Chain within the new production facility. You will be responsible for heading up and setting the direction for the manufacturing part of the project. As Head of Product Supply, you will play a major part in setting strategic leadership direction for FDB globally and contribute to new standards within our area by leveraging existing experience within large-scale manufacturing of biologics, medical device assembly, packaging and supply chain management. External US The work we do at FDB has never been more important—and we are looking for talented candidates to join us. We are growing...

Overview We are looking for a Quality Assurance Lead Engineer, Digital Technologies, who wants to participate in our journey to establish the largest end-to-end cell culture CDMO facility in North America. More importantly, someone who wants to be a part of the largest growth journey that we in FUJIFILM have ever entered. As the QA Lead for Digital Technologies, you will have direct impact on the validation of a fully automated $2 billion Greenfield CDMO facility. In the project phase, your main responsibility as the QA Lead for Digital Technologies will be to drive the Quality oversight for the direction of all GxP Manufacturing and IT Computerized Systems as well as oversight of validation documentation for these systems. You will work closely together with other areas within the project, as well as IT/Automation departments at other sites to align strategies and procedures. Once in operations, you will lead the Quality partnership responsible for ensuring...

Overview We are looking for a CIP & Clean Utilities Process DeltaV Automation Engineer who wants to participate in our journey to establish the largest end-to-end cell culture CDMO facility in North America. More importantly, someone who wants to be a part of the largest growth journey that we in FUJIFILM have ever entered. In the project phase, your main responsibility as the CIP & Clean Utilities Process DeltaV Automation Engineer will be to provide Engineering input on the design and implementation of an Emerson DeltaV control system in the areas of Clean-in-Place (CIP), WFI (Water-for-Injection) Generation and Distribution, WPU (Process Water) Generation and Distribution, Clean Steam Generation, and Waste Collection. Once in Operations, you will be responsible for and have ownership of the ongoing support of the control system for the defined process areas. You will report to the Automation Lead for DSM. External US...

Overview You as the Senior Process equipment engineer will ensure that the process equipment deliverables from Fujifilm and from EPCM provider are timely and in the required quality. You will act as driver of the process equipment activities and must be able to, proactively, facilitate cross organizational interaction with external EPCM providers and use your extensive experience from a similar role in large pharma/biotech projects External US Job Responsibilities Part of the process equipment team throughout the project being the main contact to the EPCM provider Secure on time delivery and in right quality from both Fujifilm and EPCM provider Develop and align plans, and in due time propose mitigations if plans are not met Review PI&Ds and other process design documents Provide input to Detailed Design activities in partnership with the EPCM provider Write URSs and support FAT, CQV, Commissioning, and start-up...

Overview We are looking for a Quality Assurance Lead Engineer, Drug Substance Manufacturing (DSM), who wants to participate in our journey to establish the largest end-to-end cell culture CDMO facility in North America. More importantly, someone who wants to be a part of the largest growth journey that we in FUJIFILM have ever entered. As the QA Lead Engineer DSM, you will have direct impact on the validation of a fully automated $2 billion Greenfield CDMO facility. In the project phase, your main responsibility as the QA Lead for DSM will be to drive the Quality oversight for the direction of all Drug Substance Manufacturing processes, as well as oversight of validation documentation for these processes. You will work closely together with other areas within the project, as well as QA departments at other sites to align strategies and procedures. Once in operations, you will lead the Quality partnership responsible for ensuring that all DSM systems and...

Overview We are searching for a Process Support equipment engineer that will ensure that the cleaning, steaming, and ancillary process equipment deliverables from Fujifilm and from EPCM provider are timely and in the required quality. You will act as driver of the process equipment activities and must be able to, proactively, facilitate cross organizational interaction with external EPCM providers and use your extensive experience from a similar role in large pharma/biotech projects. We are looking for someone with positive energy, entrepreneurship, and courage to empower and inspire others. You will join an organization with focus on growth, you will have a steep learning curve but most essential there is a focus on people first and what you can bring to the table. We have a diverse workplace for people driven to make a difference. External US The work we do at FDB has never been more important—and we are looking for...

Supply Chain/Sourcing Analyst Job Description Advance your career with Mindlance! We have been connecting talented IT professionals with world-class companies since 1999. Mindlance is here to help you to find the perfect fit with just the right company. Currently, we are seeking a Supply Chain/Sourcing Analyst for an exciting career growth opportunity. Make your next big career move with the kind of position that will allow you to be genuinely passionate about the work you do! Our recruiters will work closely with you to help you get the edge over the competition. Let Mindlance advocate for you – apply today! Supply Chain Analyst / Sourcing Analyst / Procurement Analyst Job Responsibilities Work schedule: Monday – Friday, 8:00AM – 5.00PM Job Description: · Reporting to the Senior Manager Supply Chain Operations, the key...