- Eisai, Inc (Chicago, IL)
- …of contact between Eisai and formulary decision-makers within identified Health Systems representing Eisai's product portfolio.The Health System Account ... for creating access to Eisai's product portfolio in identified Health Systems while building a strong corporate presence with formulary decision-makers and… more
- BioAgilytix (San Diego, CA)
- … Systems Analyst is responsible for providing support to projects related to validated computerized systems and the overall corporate infrastructure.Essential ... less than three (3) years' direct hands-on experience with computer systems validationMinimum Preferred Qualifications: SkillsProficiency in Computer System … more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …an immunotherapy in the treatment of multiple myeloma.Legend Biotech is seeking a Quality Systems Lead as part of the Quality team based in Raritan, NJ. Role ... OverviewThe Quality Systems Lead role is an exempt level position with...assurance, manufacturing compliance, clinical quality, or cell therapy.GxP Quality System knowledge, including relevant regulations and guidances (eg 21… more
- Merck & Co. (Rahway, NJ)
- …efficiency, and compliance.Lead root cause analysis and corrective/preventive actions (CAPA) related to HVAC system failures or deviations.Monitor and ensure ... and developing a team that supports HVAC operations and system infrastructure at the Rahway (RY) NJ Campus. -...Rahway (RY) NJ Campus. - This role ensures HVAC systems comply with regulatory standards (eg, FDA, cGMP), maintain… more
- Merck & Co. (Rahway, NJ)
- …BS/BA or an equivalent certification/experience in science, engineering, IT or related discipline with functional working experience in System ... will include:Project support for System Development, Maintenance, Enhancement and System Monitoring related initiatives.Serve as a liaison between the Global… more
- Merck & Co. (Durham, NC)
- …Skills:Building Automation Systems , Computerized Maintenance Management Systems (CMMS), Electrical System Troubleshooting, Equipment Maintenance, ... holidays.Key Responsibilities:Must have knowledge installing, repairing, and maintaining mechanical related equipment throughout a Manufacturing environment to include:Utility equipment… more
- Merck & Co. (Rahway, NJ)
- …SOPs to ensure practices are accurately reflected. Assist in SOP and quality- related system document approval. Support metrics by summarizing findings during ... performs audits of batch documentation, data, information, procedures, equipment and systems , and/or facilities to ensure the compliance with Standard Operating… more
- Merck & Co. (Durham, NC)
- …steam generators, Water-For-Injection generation/distribution, reverse osmosis skids, compressed gas systems )Automated Systems (eg Distributed Control System ... overtime, as needed.Preferred Experience and Skills:Associate Degree in Industrial Systems , Mechanical, Electronics, Electrical or InstrumentationSAP experience related… more
- Aequor (Vacaville, CA)
- …of bio-tech related analytical methods and practices Experience with analytical systems , data analysis, and troubleshooting Knowledge of SAP system is a ... be primarily accountable for ensuring your assigned Process Analytical Technology (PAT) Systems deployed on the manufacturing floor are fit for purpose and ready… more
- Twist BioScience (South San Francisco, CA)
- …RoleWe are seeking an experienced Staff Engineer specializing in Salesforce (SFDC) and systems integrations to join our technology team locally at the South San ... product lines and deep understanding of integration to eCommerce and ERP systems to ensure scalable, robust, and flexible cross-functional solutions that support our… more
- Merck & Co. (Durham, NC)
- …Must have knowledge installing, repairing, and maintaining mechanical related equipment throughout a Manufacturing environment to include:Utility equipment ... osmosis skids, vapor compression stills, compressed gas systemsGMP production related equipment (eg Autoclaves, Fillers, Lyophilizers, Cappers and Automated… more
- Merck & Co. (Rahway, NJ)
- …participate in Quality Notification (QN) reporting, investigations, and any related corrective action/preventive action (CAPA).- Facilitate equipment/ system ... and developmental supplies for sterile products, including critical program needs related to new products undergoing process development, new products undergoing… more
- Repligen (San Diego, CA)
- …technical assistance and expertise to the CTI/Repligen sales force and customers related to the laboratory instrumentation its sells and supports. The laboratory ... by CTI/Repligen includes variable path length UV/Vis spectroscopy instrumentation. The systems are sold primarily into the pharmaceutical and biotech industry and… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …responsible for end-to-end GxP relevant audit activities that encompasses the internal systems and processes of the Daiichi Sankyo's GxP group.Together with regional ... management teams plans, will support, conducts and reports internal systems and process audits across the organization as appropriate for the area of GxP audits… more
- Aequor (Athens, GA)
- …P&ID's. Assists the team with maintaining an up-to-date working spare parts inventory system for equipment/ systems . Completes all work in accordance with CFRs, ... and Clean Utilities including: plumbing, mechanical, electrical, HVAC, high purity water systems , clean steam, cold storage, fire systems and compressed air.… more
- Merck & Co. (Rahway, NJ)
- …least 3 years of relevant experience in automation, data analysis, or a related field.Experience developing and maintaining Building Management Systems (BMS) and ... through statistical techniquesDeveloping and implementing data analyses, data collection systems and other strategies that-optimize-statistical efficiency and quality.Develop and-maintain-Site… 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
- Legend Biotech USA, Inc. (Raritan, NJ)
- …protocols, reports).Review and approve periodic review documentation for qualified equipment/ systems (audit trails, user groups, system administration)Provide ... systems .Assist in the development of validation and qualification related policies, procedures, templates, formsProvides quality oversight on data integrity of… more
- Twist BioScience (South San Francisco, CA)
- …system validation (CSV) and GxP documentation practices, particularly for custom-built systems .Experience with system integration (eg, ERP, LIMS, QMS) using ... Sr. Director, Manufacturing Execution System (MES) (Hybrid in South San Francisco)Job DescriptionWe are seeking an experienced and highly motivated Manufacturing… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …room HVAC, refrigeration, pipefitting, and millwright activities associated with the related mechanical systems , utilities, and process equipmentPerform minor ... OverviewThis position will be responsible for maintenance support and mechanical system operations for cGMP Clinical and Commercial Cell Therapy Manufacturing on… more
