- Marchionda & Associates, L..P. (Stoneham, MA)
- Experienced Civil Engineer Project Manager JOB DESCRIPTION: Marchionda & Associates, LP, is a highly regarded full services land surveying and civil engineering ... We have a career opportunity with unlimited growth potential for a civil engineer/project manager experienced with grading, storm water and infrastructure design… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …OverviewThis position will be responsible for maintenance support and mechanical system operations for cGMP Clinical and Commercial Cell Therapy Manufacturing on ... pipefitting, and millwright activities associated with the related mechanical systems , utilities, and process equipmentPerform minor upgrades and installations of… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …will be part of Manufacturing Excellence team reporting to the Manufacturing Execution Systems Lead and will be responsible for EBR development and administration at ... This individual will support electronic batch record (EBR) updates and system improvements, support applicable process and facility updates, and support… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …environment. This role will ensure compliance within the document management system , document storage and retention, and document issuance and reconciliation.Key ... documents to ensure compliance with global and site proceduresSupport Document Management system users with workflow handling and electronic system usageManage… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …be responsible for providing engineering support for building automation and controls systems in the cGMP Clinical and Commercial Cell Therapy Manufacturing plant. ... issues, deviations, corrections, remediation and improvement efforts of automation and controls systems for facility, equipment, systems and processes in support… more
- Hawkeye Community College (Waterloo, IA)
- …Diesel Tech, HVAC, Sustainable Construction, Welding, CNC Machining, Civil and Construction Engineering, Electronics Engineering and Industrial Automation ... program accessibility, and alternative and advanced technological educational delivery systems . Demonstrated knowledge and understanding of accreditation in higher… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …process.Support the planning and execution of internal audits for all quality system areas for the manufacturing site; write audit reports, issue audit observations ... data for the monthly CRB & quarterly QSMR presentations.Fulfills the Quality System audit module site key user responsibilities - represent the Raritan site… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …, MES (Manufacturing Electronic Batch Record), and a Learning Management System .Electronic Batch Record), and a Learning Management System .Strong interpersonal ... identity or expression, age, disability, national origin, marital or domestic/ civil partnership status, genetic information, citizenship status, uniformed service… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …remediation and improvement efforts within the plant of all computerized systems .Conducts site-specific computerized system data management monitoring including ... will be responsible for providing support to implement and maintain computerized systems in the cGMP Clinical and Commercial Cell Therapy Manufacturing plant. This… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …to identify root cause and appropriate corrective actions for equipment system problemsSupport and maintain the optimization of calibration frequencies through a ... provide start-up, commissioning, and qualification/validation support of instrumentation and systems including on-the-floor troubleshooting of equipmentPromote a collaborative work… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …the QC laboratories.Perform peer review/approval of laboratory data. Utilize electronic systems (LIMS) for execution and documentation of testing.Create, review and ... WI's.Perform tasks in a manner consistent with the safety policies, quality systems and cGMP requirements.Job duties performed routinely require exposure to and… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …Quality Control. The ideal candidate will manage and maintain our automated scheduling system , ensuring that all tasks and assignments are executed on time and ... Testing Scheduling Management: Configure, monitor, and maintain job scheduling systems (eg Smart QC, BINOC)Automation: Design and implement automated testing… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …monitoring program.Perform peer review/approval of laboratory data.Utilize electronic systems (LIMS) for execution and documentation of testing.Perform tasks ... in a manner consistent with the safety policies, quality systems and cGMP requirements.Other duties will be assigned, as necessary. RequirementsA minimum of a… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …management, issues, deviations, corrections and remediation efforts for facility, equipment, systems and processes in support of personalized cell therapy production ... CAR-T manufacturing or cell processing.Ability to identify/remediate gaps in processes or systems .Experience with ICH and/or 21 CFR parts 210, 211, 1271 is required… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …therapy manufacturing process design qualification, vendor evaluation, and enterprise system interface engineering support for GMP manufacturing of engineered ... identity or expression, age, disability, national origin, marital or domestic/ civil partnership status, genetic information, citizenship status, uniformed service… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …and collaboration across relevant cross functional groups to enable robust systems training program for advancement of Raritan CAR-T Operators.Key Responsibilities ... aseptic manufacturing facility, preferably in training, project management, learning management systems , or quality systems .Knowledge of cGMP regulations and… more
- Legend Biotech USA, Inc. (Iowa City, IA)
- …reporting call activity and customer information into the appropriate call reporting system in a timely manner, submitting expenses, etc.Reports adverse events to ... identity or expression, age, disability, national origin, marital or domestic/ civil partnership status, genetic information, citizenship status, uniformed service… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …team, in a manner consistent with safety policies, quality systems , and cGMP requirements.Support manufacturing investigations, create/revise operational procedures, ... identity or expression, age, disability, national origin, marital or domestic/ civil partnership status, genetic information, citizenship status, uniformed service… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …manufacturingMaintenance and facilities managementComputerized maintenance management systems (CMMS)Quality Management knowledge, including Change control, ... identity or expression, age, disability, national origin, marital or domestic/ civil partnership status, genetic information, citizenship status, uniformed service… more
- Legend Biotech USA, Inc. (Piscataway, NJ)
- …of genome editing 2+ years hands-on experience using next generation CRISPR systems (eg Prime or Base editors)Strong expertise in immunotherapy and cell therapy ... identity or expression, age, disability, national origin, marital or domestic/ civil partnership status, genetic information, citizenship status, uniformed service… more
