Manufacturing Associates - Multiple Openings
FUJIFILM - Holly Springs, NC
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Follow Your Genki to North America's largest, state-of-the-art Life Science Manufacturing Facility & CDMOThe work we do at FDB has never been more important—and we are looking for talented candidates to join us. We are growing our locations, our capabilities, and our teams, and looking for passionate, mission-driven people like you who want to make a real difference in people’s lives. Join FDB and help manufacture the next vaccine, cure, or gene therapy in partnership with some of the most innovative biopharma companies across the globe. We are proud to cultivate a culture that will fuel your passion, energy and drive - what we call Genki.Join usWe are growing our locations and are investing more than $2 billion into establishing a new"¯large-scale manufacturing site for biopharmaceuticals in the United States to accelerate the growth of our Bio CDMO (Contract and Development Manufacturing Organization) business. This will be the largest end-to-end cell culture CDMO provider in North America.The new site will offer end-to-end solutions"¯to our customers looking to manufacture biopharmaceuticals in the US. In addition to drug substance manufacture, it will also"¯provide"¯automated fill-finish and assembly, packaging, and labeling services. The new state-of-the-art facility is located in Holly Springs, North Carolina, United States.*** Please note that this posting represents multiple openings ***About These RolesWe have opportunities for Manufacturing Associates at several levels within our Drug Substance, Drug Product / Finished Goods and Weigh and Dispense production teams.These roles will execute manufacturing processing steps and associated activities. You will also assist in scheduling daily manufacturing activities for the team. Our brand-new facility will be 24/7 operational and your role may require flexibility with working hours and/or shift.While in project phase, your schedule will be Monday-Friday, during normal business hours."¯ Upon transitioning to operations, you will be assigned to a day or night shift that will be defined prior to going into operations.What You’ll DoDuring the project phase, you may:Participate and support testing activities, such as: FAT, PQ etc.Support and contribute in the preparation of the documentation package (i.e. Standard Operating Procedures and Work Instructions)Contribute to the preparation for operational readiness related to Weigh and Dispense, bulk Drug Substance or Drug Product manufacturingPossible assignments include, supporting projects related to procedure review and/or creation, development or transfer of manufacturing business processes, testing and commissioning supportPossible travel up to 0"25% (international or domestic) may be required during the project phaseOnce we are operational, you may:Lead, execute and document manufacturing processing steps and/or manufacturing support activities, process monitoring and controlPerform operations of functional areaExecute validation protocols according to cGMP Standard Operating Procedures (SOPs)Own or establish processes and trainings to become a trainer for coworkersMaintain compliance of GMP documents and ensure your own training level is compliant and maintainedSupport and/or assist senior level associates or supervisor with scheduling daily activities for your functional area, as neededThis role requires shift work (weekend and potential for nights)Perform other duties as assignedWho You AreTo be successful, you will have:An understanding of manufacturing run cadence and order of shift activitiesOperational experience within Upstream, Downstream, Weigh and Dispense, or Drug Product areasStrong troubleshooting abilityStrong verbal and written communication skillsStrong time management skillsAbility to adapt in a fast"paced changing environment, pivot and adjust plans accordinglyAbility to think critically and have superior problem"solving skillsA team-based attitude and ability to work in a global team environment, build relationships, and communicate effectively with othersBasic RequirementsManufacturing Associate 2High School Diploma or GED2 years of Related ExperienceManufacturing Associate 3High School Diploma or GED4 years of related experience in a cGMP Manufacturing EnvironmentManufacturing Associate 4High School Diploma or GED + 6 years of experience in Life Science’s Manufacturing ORAssociate degree + 4 years’ experience in Life Science’s Manufacturing ORBA/BS + 2 years of experience in Life Science’s Manufacturing OREquivalent Military training/experienceManufacturing Associate 5High School Diploma or GED with 8 years’ experience in a life sciences manufacturing environment ORAssociate Degree with 6 years’ experience in a life sciences manufacturing environment ORBA/BS, preferably in Life Sciences/Engineering with 4 years of experience in Life Science’s Manufacturing OREquivalent Military ExperiencePreferred RequirementsManufacturing Associate 2Associate Degree, preferably in Life Sciences or similar2 Years of direct experience in a cGMP Manufacturing EnvironmentInternal or After Training: Qualified on a Support Area (i.e. Formulation Buffer Prep, Media Prep or DSM Buffer Prep).BioWorks or BTEC Capstone cGMP coursework preferredManufacturing Associate 3Associate’s + 2 Years of related experience in a cGMP Manufacturing Environment ORBA/BS Degree, preferably in Life Sciences/Engineering OREquivalent Military Training or ExperienceQualified Experience on Unit Operation (DPFG Filler or Cell Culture - Seed Train)BioWorks or BTEC Capstone cGMP coursework preferredManufacturing Associate 4Internal and after training: Experience on specific unit operations (Ex: Viral Filtration and Bulk Dispensing)Understanding of manufacturing run cadence and order of shift activitiesKnowledge in cGMP, Safety and Operational ProceduresA high degree of knowledge and expertise of the operation of specific production equipmentBioWork or BTEC Capstone cGMP Coursework PreferredManufacturing Associate 5Proficient understanding of cGMP regulations and pharmaceutical industry standardsFully Qualified in a Functional Area (Ex: Drug Product Formulation and Filling, Weigh and Dispense, Cell Culture, or Purification) while also acting as an SME on all unit operations within that functional area (i.e. Inoc, Seed Train and Production Bioreactor).BioWorks CertificationWORKING CONDITIONS & PHYSICAL REQUIREMENTSBe exposed to an environment that may necessitate respiratory protection.Be exposed to noisy environments.Have a normal range of visionClimb ladders and stairs of various heights.Experience prolonged sitting, standing, walking, bending, stooping and stretching throughout the shift, up to 12 hours.Use hand-eye coordination and manual dexterity sufficient to operate a computer keyboard, telephone, calculator, and other office equipment is required.May be required to lift up to 50 pounds on occasion.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 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.
Created: 2024-09-07