- Novo Nordisk Inc. (West Lebanon, IN)
- …of BMS hardware and software Work with PM to support the commission the system , ensuring all devices and systems are correctly connected and functional Work ... with Explorer, Word, PowerPoint, Excel, OneNote, Project, and Teams Requires demonstrated computer skills with data management systems or data bases Ability… more
- BioAgilytix (San Diego, CA)
- …computer systems validationMinimum Preferred Qualifications: SkillsProficiency in Computer System Validation, following GxP regulations and GAMP ... The Laboratory Systems Analyst is responsible for providing support to...IQ/OQ/PQ, etc.) Contributes to the development and revision of Computer System Validation procedures and policies (validations,… more
- Merck & Co. (Rahway, NJ)
- …the device constituent part of a Combination Product.Manage activities within electronic computer systems , eg, Material Management Systems (SAP), Document ... products.Must be able to build relationships within a team environment.Experience using computer systems for Quality Management Systems .Must have working… more
- Merck & Co. (Austin, TX)
- Job DescriptionPosition Summary:We are seeking a senior-level Cybersecurity Systems Automation Engineer to join the Cybersecurity Automation & AI team. This role ... enterprise platforms such as ServiceNow, Microsoft Defender, Azure, and identity systems . You will engineer cross-domain workflows that reduce manual effort,… more
- Aequor (East Syracuse, NY)
- …and understanding of 21 CFR Part 11, GAMP compliance for computer system (hardware, application software and operating system ... may require occasional shift work, weekends, and holidays.ResponsibilitiesResponsible for preparing computer system validation documents to compliance with local… more
- Twist BioScience (South San Francisco, CA)
- …Eudralex Annex 11, and internal quality standards. Oversee and execute comprehensive computer system validation (CSV) activities, including IQ, OQ, PQ protocols ... (SCADA, DCS, PLC, HMI) from a software integration perspective.Expertise in computer system validation (CSV) and GxP documentation practices, particularly for… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …for providing quality oversight over the validation and qualification activities for equipment, systems , computer systems , and processes within a cell ... assessments, technical studies, and any associated documentation in support of computer systems validation, equipment, utilities, and facility qualification,… more
- Merck & Co. (Durham, NC)
- …Calibration Management Software, Calibration of Equipment, Computerized Maintenance Management Systems (CMMS), Computer Literacy, Customer Service Management, ... and when required calibration activities to ensure applicable equipment and systems are maintained in a compliant state.Maintains the integrity of equipment… more
- Novo Nordisk Inc. (Boston, MA)
- …Nordisk within a specified geographic area, engaging with selected health systems , key academic centers, specialists, primary care providers, and other stakeholders. ... Management Assess and adapt sales and promotion strategies to align with health system account practices, care pathway decisions and managed care impact in the… more
- AUROBINDO (Durham, NC)
- …issues on & off site.Avaya IP Phone System , iPhone, etc.Monitor system performance, availability, and security.Update systems with patches and security ... configures, and supports internal and/or external networks. Maintains all systems , applications, security, and network configurations. Troubleshoots network performance.ResponsibilitiesDesktop… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Engineering, Information Technology, or related field - Required Master's Degree in Computer Science, Life Science, Engineering, or Information Systems - ... in overseeing the development, validation, implementation, and integration of GxP-regulated systems across the organization. This position ensures that all global … more
- Aequor (Piscataway, NJ)
- …publishing (eg, Acrobat, DXC Toolbox, authoring templates). Understanding of computer system validation principles and change control processes. ... Manager requisitions are about to go live in the system ; one based in Princeton, NJ, and the other...This role will use eCTD publishing and document management systems to compile high-quality, technically valid submissions and reports… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Qualifications (from an accredited college or university)Bachelor's Degree in Information Systems , Computer Science or business related discipline required ... for the administration and operational support of Daiichi Sankyo's Veeva CRM system within IT. They'll collaborate with various sales and marketing customers to… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …shift work which will include weekends. Qualifications: A Bachelor's degree in Computer Science, Information Systems , or Information Security is required; ... of IT security strategy and serving as a security advisor to ensure IT systems are implemented and maintained to the highest security standards. Individuals in this… more
- Aequor (San Diego, CA)
- …publishing (eg, Acrobat, DXC Toolbox, authoring templates). Understanding of computer system validation principles and change control processes. ... This role will use eCTD publishing and document management systems to compile high-quality, technically valid submissions and reports...manage overall timelines for completion. As needed, work with system business owners, IT, and QA to support … more
- Merck & Co. (Rahway, NJ)
- …clinical and commercial assembly equipment and processes for medical devices/drug delivery systems . Reporting to the Director responsible for this area, you will ... develop robust assembly specifications with sound justification.Understand medical device/delivery system product design, functionality, storage, and handling requirements to… more
- Repligen (Clifton Park, NY)
- …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 ... This role requires in-depth knowledge and experience of manufacturing solutions and systems as well as solves complex problems and takes on new perspectives… more
- Novo Nordisk Inc. (West Lebanon, IN)
- … systems design preferred Knowledge of pharmaceutical manufacturing quality system , including knowledge of FDA requirements preferred Strong project management ... update relational databases required Knowledgeable in GMP processes, Quality Management System (QMS), & standard improvement systems preferred Demonstrated… more
- Aequor (Bothell, WA)
- …working to support, enhance, and maintain compliance for the GxP benchtop systems and instrumentation as well as site and global applications used within ... with experience in Laboratory equipment, benchtop instrumentation, and Quality System disciplines. The candidate needs to understand shop floor activities,… more
- Lovelace Biomedical Research Institute (Albuquerque, NM)
- …experience with Microsoft Office and the ability to learn department-specific computer systems as needed.United States Citizenship or Permanent Residency ... will also be responsible for the oversite of the Institute's physical security system to include maintaining and monitoring alarms, access control systems ,… more
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