- Legend Biotech USA, Inc. (Raritan, NJ)
- …issues.Perform tasks in a manner consistent with the safety policies, quality systems and cGMP requirements .Require minimal direction to complete tasks, know ... treatment of multiple myeloma.Legend Biotech is seeking a Quality Systems Lead as part of the Quality team based...therapy manufacturing facility to support both clinical and commercial requirements in a sterile GMP environment. This role will… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …actions.Perform tasks in a manner consistent with the safety policies, quality systems , and cGMP requirements .Drive continuous improvementOther duties may be ... providing quality oversight over the validation and qualification activities for equipment, systems , computer systems , and processes within a cell therapy… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …security of common threats, vulnerabilities, and exposures applicable to IT systems Physical Requirements : 5% overnight travel required. **This position ... 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
- BioAgilytix (San Diego, CA)
- The Laboratory Systems Analyst is responsible for providing support to projects related to validated computerized systems and the overall corporate ... ResponsibilitiesParticipates in implementation planning, qualification and/or validation of laboratory systems and softwareAuthors and reviews validation deliverables (risk assessment,… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …and internal stakeholders to execute audits effectively. Ensure the internal systems auditing program fulfills regulatory requirements performs audits, ... 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… more
- Merck & Co. (Rahway, NJ)
- …Leadership, Plant Maintenance, Preventative Maintenance Programs, Process Control Systems , Project Management, Regulatory Compliance, Regulatory Requirements ... Rahway (RY) NJ Campus. - This role ensures HVAC systems comply with regulatory standards (eg, FDA, cGMP), maintain...ensure compliance with GxP (as applicable) and other regulatory requirements .Lead the operation of the site BAS and HVAC… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …tasks on time in a manner consistent with safety policies, quality systems , and cGMP requirements .Build strong partnerships with Manufacturing, Warehouse, ... production of a personalized cell therapy to support both clinical and commercial requirements in a sterile cGMP environment. Job duties will be performed within a… more
- Aequor (Thousand Oaks, CA)
- …(Veeva Vault), LIMS and/or SmartLab (LMES). Experience and knowledge of Data Integrity Requirements in QC systems . Proficient in Microsoft Office (ie, Outlook, ... Under minimal supervision analyze environmental monitoring samples, cross check sample requirements against SOPs and enter results in a laboratory information… more
- Merck & Co. (Durham, NC)
- …ability to follow complex instructions and use our Manufacturing Division business systems (SAP, ADP eTime, etc.)Physical requirements - Must be able ... room or GMP/regulated manufacturing environment.Experience working on Clean Utility systems .#MSJR VETJOBS Current Employees apply HERE Current Contingent Workers… more
- Merck & Co. (Durham, NC)
- …ability to follow complex instructions and use our Manufacturing Division's business systems (SAP, ADP eTime, etc.)Physical requirements - Must be able ... room or GMP/regulated manufacturing environment.Experience working on Clean Utility systems .#MSJRCurrent Employees apply HERE Current Contingent Workers apply HERE… more
- Merck & Co. (Durham, NC)
- …perform routine maintenance tasks, work with and troubleshoot complex process systems , including but not limited to:Utility Equipment (eg boilers, chillers, Cooling ... towers air compressors, waste deactivation systems )Clean Utility Equipment (eg HVAC, Clean steam generators, Water-For-Injection generation/distribution, reverse… more
- Merck & Co. (Durham, NC)
- …and when required calibration activities to ensure applicable equipment and systems are maintained in a compliant state.Maintains the integrity of equipment ... detectors) to facilitate analysis and repair of equipment and control systems .Identifies revisions, deletions, or additions to the calibration and maintenance… more
- Merck & Co. (Rahway, NJ)
- …solutions to business needs by designing and implementing new data management systems Employ innovation and technology solutions to manage data warehousing more ... and Strategic Roadmap, supporting the organization's transition toward future-ready systems and modern data architectures. Primary Activities Design and develop… more
- Aequor (Athens, GA)
- …and Clean Utilities including: plumbing, mechanical, electrical, HVAC, high purity water systems , clean steam, cold storage, fire systems and compressed air. ... Conduct regular inspections and preventative maintenance to ensure systems are operating efficiently and safely. Engage in technical activities/troubleshooting… more
- Merck & Co. (Rahway, NJ)
- …techniquesDeveloping and implementing data analyses, data collection systems and other strategies that-optimize-statistical efficiency and quality.Develop ... analysis, or a related field.Experience developing and maintaining Building Management Systems (BMS) and Building Automation Systems (BAS), including Historian,… more
- Merck & Co. (Rahway, NJ)
- …materials to ensure conformance to appropriate regulatory and company requirements for clinical supply manufacture and/or regulatory inspections. Independently ... performs audits of batch documentation, data, information, procedures, equipment and systems , and/or facilities to ensure the compliance with Standard Operating… 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. (Rahway, NJ)
- …initiatives.Serve as a liaison between the Global Labeling Business Users of the Systems and the associated IT Partners for defining Business Requirements and ... collaboration with IT Business Partners including activities relating to Requirements Gathering, Documentation, Testing, Implementation, Deployment and Hypercare phases.Facilitate… more
- Merck & Co. (Rahway, NJ)
- …will be to maintain all equipment in accordance with GMP and Safety requirements , as well as exercising Reliability Maintenance best practices to ensure timely ... of Clinical Supplies and Development Batches to meet Clinical Development Program requirements . This will require routine interaction with Partner Groups such as GES… more
- Merck & Co. (Rahway, NJ)
- …standards for how automation interacts with ITSM, detection engines, identity systems , and risk scoring frameworks.Serve as lead integrator between the Automation ... AI Lead to ensure insights are engineered into secure, responsive systems .Required QualificationsBachelor's degree in Computer Science, Engineering, or a related… more
