Manufacturing Associate 4, Drug Product Filling (1st Shift) at Fujifilm

Position OverviewThe manufacturing associate in Drug Product Manufacturing will have a primary task for operation of filling line including all tasks related. This role will also support projects which influence manufacturing processes for DPM including training of others. This position will also support and assist in scheduling daily manufacturing activities for the team. This manufacturing facility will be 24/7 operational and the role may require to be flexible with working hours or shift rotation.Company OverviewFUJIFILM Biotechnologies is building the future of bioproduction in Holly Springs North Carolina. By end of 2025 well open North Americas largest end-to-end CDMO biopharmaceutical manufacturing facility offering drug substance production fill-finish and packaging under one roof. Were 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 were proud to cultivate a culture that will fuel your purpose energy and drivewhat we call Genki. Ready to shape the future of medicine Lets transform healthcare together! Holly Springs North Carolina combines small-town warmth with proximity to Raleighs thriving tech scene making it the perfect blend of community and opportunity. Fujifilm is globally headquartered in Tokyo with over 70000 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: DescriptionWhat Youll Do During the project phaseParticipate and support testing activities such as FAT PQ etc. as well as other related activitiesSupport and contribute to the preparation of the documentation package as e.g. Standard Operating Procedures Work InstructionsContribute to the preparation for operational readiness related to bulk drug product manufacturing Possible assignments include: Supporting projects related to procedure review and/or creation development or transfer of manufacturing business processes as well as testing and commissioning supportTravel up to 0-25% (international or domestic) may be required during the project phaseIn operations Lead execute and document manufacturing processing steps and/or manufacturing support activities as well as process monitoring and controlPerform operations of the Drug product filling lineExecute validation protocols according to cGMP Standard Operating Procedures (SOPs)Own the establishment of processes and trainings to become a trainer for coworkersMaintain compliance of GMP documents and ensure own training level is complaint and maintainedSupport and/or assist senior level associates or supervisor with scheduling daily activities on drug product manufacturing floor as neededThis role requires shift work (weekend and potential for nights)Perform other duties as assignedBasic RequirementsHigh School Diploma or GED6 years of direct experience in a manufacturing environmentPreferred RequirementsAssociates Degree 4 years of direct experience in a cGMP manufacturing environment ORBA/BS 2 years of direct experience in a cGMP manufacturing environment Equivalent Military training or experience Experience on specific unit operations (ex: Viral Filtration and Bulk Dispensing)Understanding of manufacturing run cadence and order of shift activities Knowledge of cGMP safety and operational proceduresA high degree of knowledge and expertise of the operation of specific production equipmentWORKING CONDITIONS & PHYSICAL REQUIREMENTSBe exposed to an environment that may necessitate respiratory protectionBe exposed to noisy environmentsHave a normal range of visionClimb ladders and stairs of various heightsExperience prolonged sitting standing walking bending stooping and stretching throughout the shift up to 12 hoursUse hand-eye coordination and manual dexterity sufficient to operate a computer keyboard telephone calculator and other office equipment is requiredMay be required to lift up to 50 pounds on occasionTo 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 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 InformationFujifilm is committedto 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 InformationIf 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 ().Required Experience:IC Key Skills Marketing,Quality Assurance,Agile,Product Demos,Analysis Skills,Jira,Project Management,Product Management,Qualitative Analysis,Confluence,Internet Of Things,Product Development Employment Type : Unclear Department / Functional Area: Manufacturing Experience: years Vacancy: 1