- Daiichi Sankyo, Inc. (Bernards, NJ)
- … - Preferred Experience10+ years of experience in GxP-regulated IT system implementation , validation, and compliance in pharma/biotech/medical device industry ... Services Lead plays a key role in overseeing the development, validation, implementation , and integration of GxP-regulated systems across the organization. This… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- … development. Act as R programming SME and functional representative of R systems and infrastructure to identify system and technology development needs and ... to provide statistical programming technical support related to R programming, R related system and technology. Develop and drive R programming, package, and R shiny… more
- Merck & Co. (San Francisco, CA)
- Job Description Position Description: Associate Director, DSCS Digital Implementation Project ManagerWithin the Development Sciences and Clinical Supply (DSCS) ... of the -include:Project Management: help develop and maintain a comprehensive implementation plan for each use-case, inclusive of timelines, milestones, and… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …process as well as oversight of the MES team to ensure smooth implementation of system enhancement activities.Accurately and reliably gauge task effort and ... of Manufacturing Excellence team reporting to the Manufacturing Execution Systems Lead and will be responsible for EBR development...and interface with IT to drive the design and implementation of new system updates for cell… more
- Aequor (Devers, TX)
- …skilled and experienced contractor to lead the Direct Materials Sourcing initiatives and the implementation of a new ERP system (SAP) at multiple Client sites. ... etc. Vendor Setup: Manage vendor setup from one ERP System to another ERP Systems (ie, Oracle...medical device industry Min 4 yrs exp with Procurement UAT, Training others on ERP systems , and implementation… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …Individuals in this position will also have additional duties assisting with the implementation of IT security strategy and serving as a security advisor to ensure ... IT systems are implemented and maintained to the highest security...performing technical risk and vulnerability assessments at the network, system , and application level. Some responsibilities developing and implementing… more
- Twist BioScience (South San Francisco, CA)
- …Execution System (MES) Director to lead the strategic development, implementation , and optimization of our custom, in-house developed MES solutions across our ... system validation (CSV) and GxP documentation practices, particularly for custom-built systems .Experience with system integration (eg, ERP, LIMS, QMS) using… more
- Merck & Co. (Durham, NC)
- …Skills:Building Automation Systems , Computerized Maintenance Management Systems (CMMS), Electrical System Troubleshooting, Equipment Maintenance, ... troubleshooting using the Problem Solving Application (PSA) tool.Support CAPA implementation .Liaison between Mechanical Service Engineer (MSE) and Operations.Review work… more
- Merck & Co. (Durham, NC)
- …steam generators, Water-For-Injection generation/distribution, reverse osmosis skids, compressed gas systems )Automated Systems (eg Distributed Control System ... problems that cross into inter-related unitsAssist in the identification, development, and implementation of new systems which enhances the operation and/or… more
- Merck & Co. (Durham, NC)
- …of the Site Automation team responsible for the assigned process control systems in support of manufacturing operations located in Durham, NC.This Individual will ... be-responsible for problem resolution, implementation of process control, data collection techniques, and troubleshooting in compliance with SDLC, GMP, safety, and… more
- Repligen (Clifton Park, NY)
- …techniques of Lean Manufacturing and incorporate it into the culture.Lead the implementation of the Repligen Performance System (RPS) throughout Engineering.Lead ... single-use state-of-the-art single use components and innovative storage and transfer systems that optimize fluid transfer and reduces the number of connections… more
- Merck & Co. (Rahway, NJ)
- …performs audits of batch documentation, data, information, procedures, equipment and systems , and/or facilities to ensure the compliance with Standard Operating ... ensure practices are accurately reflected. Assist in SOP and quality-related system document approval. Support metrics by summarizing findings during documentation… more
- Merck & Co. (Durham, NC)
- …CMMS system platforms and route engineering change requests through CMMS system .Expand knowledge into other systems , capable of managing change in the ... Data stewardship and assisting with successful shutdown planning and implementation with associated department(s).- General Profile: Individual contributor role… more
- Novo Nordisk Inc. (Durham, NC)
- … systems and associated applications required Proven expertise in system interfacing and integration required Experience in Project Management, Batch Reporting, ... development & initiative to understand the site process control systems , data management systems , and differing data...on risk management & mitigation Lead the training & implementation of effective change management Lead Support Corporate, PS… more
- Aequor (Thousand Oaks, CA)
- …plates. Working in a laminar flow hood. Work with Laboratory Information Management System (LIMS) and/ or SmartLab (LMES) with efficiency and accuracy. Job Summary ... sample requirements against SOPs and enter results in a laboratory information management system (LIMS) and/ or SmartLab (LMES). This position will work in a team… more
- Twist BioScience (South San Francisco, CA)
- …and ensure seamless data flow between Sales, Data, and Marketing Clouds. Implementation & IntegrationOversee technical implementation with developers, admins, and ... third-party vendors.Guide integration between Salesforce and other enterprise systems (eg, ERP, Order Management Systems , external data sources).Provide… more
- Eisai, Inc (Nutley, NJ)
- …and CDISC standards. The role will require excellent technical skills in SAS systems and application development and experience. The Associate Director must be a ... in designing and developing programs in Eisai Clinical Computing Environment Implementation of new programs, enhancements & support of Eisai Clinical Computing… more
- Merck & Co. (North Wales, PA)
- …the guidance of an Executive Director, within the Value and Implementation , Outcomes Research the incumbent has the following responsibilities:1.) development of ... developmental drugs and/or vaccines on a worldwide basis and 3.) development and implementation of Outcomes Research (OR) and Real World evidence programs to meet… more
- Merck & Co. (Rahway, NJ)
- …drug product with device constituent part.Lead/ support the development, implementation and continuous improvement of Device Development and Device Technical ... is preferred):BS/ BA degree in Mechanical Engineering, Biomedical Engineering, Industrial and System Engineering, or other types of engineering with a minimum of 20… more
- Eisai, Inc (Nutley, NJ)
- …area Strong analytical skills and report writing skills Experience with GxP systems including computer system validation and associated regulations, recommended. ... including audit and inspection management and oversight of the Quality management system . This role is responsible for Good Clinical Practice (GCP) oversight, and… more
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