- Novo Nordisk Inc. (Durham, NC)
- …implement the necessary changes to the automation/IT-related specifications & maintenance plans System assessments & testing of operating systems , software, & ... hardware Perform system assessments & testing of operating systems , software, & hardware Perform automation/IT validation activities in accordance with Novo… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …, configuration and associated validation activities of Daiichi Sankyo Pharmacovigilance Safety systems , and fulfillment of data change requests. ... and process improvements.Provide oversight, Manage Implementation and documentation of PV Safety systems Change Request supporting documents and evidenceReview… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …Nordisk and FDA requirements Understands PSP operations, including program business rules, SOPs, systems used (including CRM, Safety system and PSP ... correct systems Quality monitoring activities to include CRM system case evaluation, Safety system case evaluation, retroactive call listening, call… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionThe Global Regulatory Affairs and Clinical Safety Global Process Lead is responsible for overseeing and managing Global Regulatory Affairs & Clinical ... Safety global business processes. This includes defining and optimizing...process for their respective global business processes (eg, enabling systems , upstream and downstream transfer of information and assets).Accountable… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …protocols and the Clinical Study Oversight Plan, day-to-day management of DS Safety Notification Letter (SNL) System and oversee TMF activities. This ... DMP, SOWs, PVAs, Clinical Study Oversight Plans, day-to-day management of DS Safety Notification Letter (SNL) System and presentations and documents.Electronic… more
- Lovelace Biomedical Research Institute (Albuquerque, NM)
- …EH&S Technician II will support the institute in the areas of environmental safety and health ensuring compliance with city, state and federal regulations. The EH&S ... conduct radiation training for employees. Performs noise surveys and laboratory safety inspections. Collects, analyzes, ships and packs samples. The ES&H Technician… more
- Merck & Co. (Rahway, NJ)
- …in some 150 markets.Primary Responsibilities: Accountable for all environmental, health, and safety (EHS) program execution and compliance at a portion of our ... engagement and success.Demonstrate accountability and responsibility for Environment, Health, Safety and Sustainability (EHS&S) performance and compliance through active… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …agreements including, but not limited to, Master Service Agreements (MSAs), Safety Data Exchange Agreements (SDEAs) and Statement of Works (SOWs). The ... to the contractual and budgetary aspects of contracting with health care systems , health care professionals and organizations Maintains a deep understanding of CMR… more
- Merck & Co. (Durham, NC)
- …a member of the Automation team responsible for the support of process control systems used in manufacturing operations located in Durham, NC.- We use a variety of ... responsible for problem resolution, administration and monitoring of process control systems , data collection & analytics, and troubleshooting. They will actively… more
- Merck & Co. (Durham, NC)
- … Systems , Water for Injection (WFI), and Clean Steam (CS)) Automated Systems (eg Distributed Control System (DCS), Programmable Logic Controllers (PLC), ... Matter expert for LOTO and permit writing for maintenance activities, Safety Management Information Systems (SMIS) transactions Knowledge of… more
- Merck & Co. (Durham, NC)
- …chromatography columns)-Support Equipment (eg washers, autoclaves, tube welders/sealers)- Automated Systems (eg Distributed Control System (DCS), Programmable ... unitsAssisting in the identification, development, and implementation of new systems which enhances the operation and/or engineering processesAdapts and implements… more
- Merck & Co. (Lower Gwynedd, PA)
- …of a variety of automated processing and operational and informational technology systems .Apply deep expertise in the computer system validation process of ... staff while building and maintaining strong working relationships.Serve as a system administrator of equipment applications, temperature monitoring systems , and… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …gathering, and technical feasibility and delivery. The role supports all phases of systems development for global informatics systems , ETL and integrations. The ... Tech Lead must develop and implement informatics systems and programs to support the business functions of Daiichi Sankyo (DS) in the US, EU, Japan, and other global… 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
- Exela Pharma Sciences, LLC (Lenoir, NC)
- …priorities, forecasting, and identifying resources needed to make improvement to existing systems as needed. This role is the site Subject Matter Expert (SME) ... for site GMP Clean Utilities infrastructure and systems (WFI, Clean Steam, Pharmaceutical/Oil-Free Compressed Air, Process Gases, HVAC, etc.) and applications in… more
- Exela Pharma Sciences, LLC (Lenoir, NC)
- …The maintenance technician, utilities will maintain facilities, production supporting equipment/ systems and quality, in a GMP regulated manufacturing environment, ... ensuring mechanical equipment/ systems and production operate efficiently. Job Responsibilities: Independently perform repairs/maintenance of facilities, utilities,… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …is an inspection ready state.Perform tasks in a manner consistent with the safety policies, quality systems and cGMP requirements.RequirementsA minimum of a ... planning and execution of internal audits for all quality system areas for the manufacturing site; write audit reports,...users for audit process, and control access to any systems used to support audits/inspections.Provide support to quality … more
- Merck & Co. (Baton Rouge, LA)
- …Animal Health Intelligence North American Facilities. Responsibilities include system upgrades, troubleshooting issues, identifying trends, process monitoring, ... with senior leadership. SPECIFIC RESPONSIBILITIES: Evaluates automated and information technology systems and develops strategies to optimize and ensure quality and… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …in the face of complexity or disagreement Utilizes and enhances procurement and sourcing systems and tools: Follows up on system usage and proactively ensures ... future capabilities. We're responsible for regulating accounting, upholding workplace safety , managing our supply chain and sampling, supporting technological and… more
- Merck & Co. (Durham, NC)
- …be responsible for aligning maintenance projects with the business objectives around Safety , Compliance and Cost.- The Mechanical Services Engineer must be able to ... and maintenance activities are completed in accordance with established safety , GMP, and calibration/maintenance procedures.Work with the Operations, Technology,… more
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