- Merck & Co. (Rahway, NJ)
- …business improvement initiatives and leverage your network to drive change .Education & Experience:Bachelor's degree in Chemical Engineering , Bioengineering, ... will be instrumental in supporting DS commercialization, process characterization, control strategy development, tech transfer to internal and external manufacturing… more
- Novo Nordisk Inc. (West Lebanon, IN)
- …for problems associated with investigations Completes accurate and timely assessments associated with change control activities Ensures change control ... (Downstream) Essential Functions Assist with coordinating fabrication, procurement, installation, engineering start-up, verification and validation activities of new equipment… more
- Novo Nordisk Inc. (Durham, NC)
- …machine learning for anomaly detection and predictive maintenance, advanced control strategies for quality improvements, inventory management using predictive ... relevant areas Own self development & initiative to understand the site process control systems, data management systems, and differing data sources (PCS, MES, SAP,… more
- Merck & Co. (Rahway, NJ)
- …influence across the enterprisePreferred Experience and Skills: Project management, including change control and equipment qualificationSAP experience related to ... and other regulatory requirements.Lead the operation of the site BAS and HVAC control systems. Manage the development and oversight of site operations through data… more
- Eisai, Inc (Exton, PA)
- …deviations. Provide timely reporting, investigation, and resolution of manufacturing deviations, change control , and corrective and preventive actions.6. Oversee ... and close-out of documentation, manufacture of DS/ADI materials, and suite change -over ensuring compliance to relevant regulations. The Associate Director is also… more
- Merck & Co. (Durham, NC)
- …schedule.Must be willing to learn multiple CMMS system platforms and route engineering change requests through CMMS system.Expand knowledge into other systems, ... solving and troubleshooting Preferred Experience and Skills: Project management, including change control and equipment qualificationSAP experience related to… more
- Twist BioScience (South San Francisco, CA)
- …ensuring user adoption, effective GxP training programs, and adherence to change control procedures for custom software releases.QualificationsBachelor's degree ... development and external services, and demonstrating ROI for MES investments. Change Management: Lead change management efforts related...in Computer Science, Software Engineering , Electrical Engineering , or a related technical… more
- Merck & Co. (Durham, NC)
- …coordination leadership and implementation of troubleshooting activities and change control .On-floor support of manufacturing activities.Identify and ... member of the Site Automation team responsible for the assigned process control systems in support of manufacturing operations located in Durham, NC.This Individual… more
- BioAgilytix (Durham, NC)
- …checks, and setting up clear governance so everyone knows who can see or change each dataset. You'll start as a "player-coach," doing the technical heavy lifting ... governance framework, with hands-on responsibility for data quality, access control , and compliance protocols.Define standards, build quality assurance processes,… more
- Novo Nordisk Inc. (Durham, NC)
- …to Manager, Technical Support. Essential Functions Coach & mentor peers, Engineering personnel & Process Maintenance Technicians. Support technical development of ... cLEAN® tools within the main areas of problem solving, project & change management. Lead cross-functional process improvements. Develop plans to improve the… more
- Merck & Co. (Rahway, NJ)
- …and complex document types, as required, including deviations, investigations, change records, analytical method validations, method transfers, analytical methods, ... Minimum Requirements: Bachelor's degree (BS) in an appropriate-Science or Engineering discipline ( engineering , chemistry, biology, biochemistry, microbiology).-… more
- Aequor (Thousand Oaks, CA)
- …and Vial/Syringe Filling operations Experience with various quality systems including change control , deviations, corrective and preventative actions, and/or ... network: Manufacturing, Process Development, Supply Chain, Quality, and Facilities & Engineering . A high degree of interactions and collaboration is required across… more
- Merck & Co. (Durham, NC)
- …project implementations. Educational requirements: Required:B.S./BA Degree in Science / Engineering / Business or Supply Chain Management- Required experience and ... potential. Preferred experience and skills: Master's degree in science / engineering / business or supply chain management-Experience in developing and updating… more
- Merck & Co. (South San Francisco, CA)
- …implementing, and optimizing GenAI approaches to streamline the creation and quality control (QC) of regulatory submission documents. The candidate will be part of ... Science, Statistics, Applied Mathematics, Bioinformatics, Computational Biology, Chemical Informatics, Engineering , or related fieldsRequired Experience - and Skills: -Proficiency… more
- Merck & Co. (Durham, NC)
- …Regulations, Quality Assurance, Risk Management, Deviation Management, Product Release, Change Control ).- Supply Chain Management:-Manage coordination with ... Oversight. - Minimum Education Requirement : Bachelor's Degree required.-Degree in Engineering or Science strongly preferred. - REQUIRED Experience and Skills :-… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …documentation on the platform process description and collaborate to the global change control process and global investigations.Maintain global program project ... global implementation.Requirements BS required, Ph.D. preferred in technical discipline: engineering , science, or related field.Minimum 8 years of industrial… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …Therapy cGMP manufacturing and project planning experience preferred.Provide technical expertise of Change Control process as well as oversight of the MES ... levels within the organization.RequirementsA minimum of a Bachelor's degree in engineering or related field or equivalent experience required. Advanced degree… more
- Merck & Co. (Durham, NC)
- …participate and ensure an effective "hand shake" during the Operations Shift Change Tiers and Maintenance Tier 1.Properly distribute the shift maintenance work load ... and safe maintenance and repair of equipment using Hazardous Energy Control Procedures (HECPs)Compliance with current good manufacturing procedures(cGMP), safety and… more
- Insmed Incorporated (San Diego, CA)
- …with both internal and external drug substance analytical, quality control , quality assurance, and manufacturing teams.Exercise judgment in selecting methods, ... or a PhD with 3 years experience in life sciences, chemical engineering , biochemistry, or related field.Experience working in a biopharmaceutical laboratory focusing… more
- Insight Global (Fremont, CA)
- …ECS is a Documentation and Change Order (ECR/ECO) specialist responsible for engineering change control process as part of PLM. Beyond generating ... to solutions in alignment with cutin strategies, E&O and effectivities POC for Change Control processes in Engineering Monitor and prioritize tasks to ensure… more
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