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Experience with Microsoft Office, Smartsheet and laboratory LIMS. 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.
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JIRA, Confluence, Smartsheet, Adobe Photoshop, Adobe Acrobat, and DAMs. Drive the production roadmap for mastering and localization processes accounting for global campaign needs including translation, subtitling, and voice over.
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Identify opportunities to leverage technology to improve ability to compile, analyze, and report item creation and data (e.g. smartsheet, access, excel, JDE, Cantor, AQ, etc.) We have a broad product offering with a well-regarded brand portfolio including the #1 position in windows; vinyl siding; metal accessories; metal roofing and wall systems; and insulated metal panels.
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Ability to utilize Microsoft Excel, Word, PowerPoint, SharePoint, Smartsheet, and various database querying tools. When completed, the Amgen FleX Batch facility will combine the latest in disposable technologies with traditional stainless-steel equipment to allow for maximum flexibility in operations.
Full-timeExpandApply NowActive JobUpdated 3 days ago - UpvoteDownvoteShare Job
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Proficient user of software applications (Smartsheet, Tableau, Miro) Establish and optimize planning standards that articulate the run rate, plant changeover, and product re-introduction capabilities as well as plant shutdown duration and frequency.
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Experience with ERP software (JDE, Oracle, or OneStream) and/or DB tools (Access / SQL) and Microsoft Office suite (Excel, PowerPoint, Word). Implement data governance processes for item master data maintenance.
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Working knowledge of ASTM E2500, Smartsheet, Trackwise, MasterControl and/or Kneat validation software. 3+ years of experience in GMP Quality Assurance and/or similar role. Understanding of cell culture, upstream processes, large scale recovery and/or downstream processes.
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Good understanding of CMMS systems (Maximo, SAP, Blue Mountain, ETC.) Work with System Owners to ensure compliance in construction of Job Descriptions, Spare Parts (ASL), and Data Sheets (Calibration Requirements.
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Associate Maintenance Planner. The FleX Batch facility will not only feature the best in-class drug substance manufacturing technologies with embedded industry 4.0 capabilities, but it will also integrate sustainability innovations to reduce carbon and waste, as part of Amgen's plan to be a carbon-neutral company by 2027.
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Prior experience with Smartsheet and electronic validation software (e.g. Kneat). Understanding of one or more of the following processes preferred:GxP systemsSerialization Infrastructure (IT and/or OT related)Manufacturing Execution Systems (MES) Process Control Systems (PCS) and Building Management Systems (BMS)PI HistorianPHYSICAL DEMANDSAbility to stand for prolonged periods of time up to 30 minutesAbility to sit for prolonged periods of time up to 120 minutesFDBN is an Equal Opportunity Employer.
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Produce and distribute regular training reports and Smartsheet dashboards as required to support management and leadership team in operations. Knowledge of Smartsheet programs. Produce and distribute regular training reports and Smartsheet dashboards as required to support management and leadership team in operations.
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Hiring #urgenthiring #PMjobs #projectmanagementjobs #projectcoordinator #technicalwriting #documentation #supplychain #LMS #learningmanagementsystem #ANC #SOP #JHA #CDOCS #NCjobs #northcarolinajobs #remotejobs #hybridjobs #CTHjobs #W2jobs #USC #GC.
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