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The Team Lead for Authoring Support Group will be part of the Global Regulatory Operations group and will develop and manage the authoring support group within Regulatory Affairs (RA) to ensure timely and high-quality document delivery to the Regulatory Publishing Group.
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Reporting to the Senior Director, Supply Chain, US Warehouse and Logistics, the Manager, US Warehouse and Logistics will oversee the 3PL warehouse operation and supports Genmab’s Qualification and Validation activities.
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A Wafer Fab Process Engineer supporting the Deposition process area is required by the Microcircuit Emulation Center at SRI International (formerly Sarnoff Corporation) to support the manufacturing of microcircuits (integrated circuits.
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Manufacturing, Validation, Site Automation, Engineer, Quality Control, and Global Technical Operations (GTS) associates. Employee will be required to work closely with Manufacturing, Validation, Site Automation, Engineer, Quality Control, and Global Technical Operations (GTS) associates.
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A Utility Plant Engineer (UPE) must be able to operate and understand each individual piece of equipment and systems in all the University’s energy plants in a safe, reliable, and economical manner.
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In this role, you will define, implement and maintain the validation program for the site, ensuring compliance to the company quality guideline, FDA regulatory requirements, and cGMP regulations.
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Client) is seeking a Site/Civil Project Engineer/Manager with land development focus to join its collaborative team in Princeton, NJ. Valid Professional Engineer license; Ability to interact well with coworkers, clients, and regulatory agencies.
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Additional areas of support include Drug Safety and Pharmacovigilance, Computer System Validation and Good Laboratory Practices (GLP). Work in close collaboration with colleagues in R&D Quality Management, operational units in Drug Development (Clinical Development, Clinical Operations, Data Management, Manufacturing, Medical Affairs, Laboratories, Pharmacovigilance, Regulatory Affairs, Translational Medicine, vendors (CSPs) and partners in GMP QA.
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In the absence of the Director, the Assistant Chief Engineer will assume the administrative, financial and operating aspects of the hotel as they relate to engineering. Location: Graduate Princeton - Princeton, NJ Overview: The Assistant Chief Engineer is responsible for the day-to-day operations of the hotel's engineering department.
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DSDH DSSPE - Real World and Multi-Omics Data Engineering, Solutions and Pipelines Johnson & Johnson - Innovative Medicine R&D is recruiting for Senior Data Science, Bioinformatics / Senior Data Engineer to join the R&D Data Science, Solutions, Privacy and Ethics (DSSP) department.
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HDR NJ Transportation Group is seeking to hire a Senior Bridge Engineer to work on bridge projects. The Sr. Bridge Engineer will also participate in business development and contribute to the growth of the bridge group.
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Proficiency with drug safety databases (i.e., Argus), electronic data capture (EDC) systems, Medical Dictionary for Regulatory Activities (MedDRA) and World Health Organization (WHO) Drug dictionary coding.
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Ability to interact successfully with internal and external stakeholders including Clinical Development, Regulatory Affairs , Drug Safety and Pharmacovigilance, Legal , Commercial, Sales and Marketing, etc.
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Serve as subject matter expert for residual DNA by qPCR, host cell protein ELISA, Residual Protein An ELISA, binding activity ELISA, Capillary Electrophoresis (CE), and capillary isoelectric focusing electrophoresis(cIEF), including qualification, assay validation and transfer activities.
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We are seeking a highly skilled Project Engineer with a focus on Site Design, who will play a pivotal role in managing and developing a variety of civil projects. Familiarity with relevant regulatory standards and permitting processes.
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validation engineer regulatory jobs in Princeton, NJ
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