- 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)
- …Documentation, Testing, Implementation, Deployment and Hypercare phases.Facilitate and oversee the System Support Model for systems within remit including: ... Job DescriptionAssociate Director, Business System Labeling Management Required experience and skills: Min....liaison between the Global Labeling Business Users of the Systems and the associated IT Partners for defining Business… more
- Merck & Co. (Rahway, NJ)
- …and Validation plans around equipment, critical utilities, and computer systems .- Prepare and approve qualification protocols and summary reports.- Execute ... Prepare Validation plans and annual reports around critical equipment and systems .- Maintain GMP documentation where applicable, such as GMP engineering drawings… 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 ... specification data within the computerized calibration and maintenance management system .Troubleshoots equipment and performs necessary repairs. Utilizes various instruments… 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)
- …review with clinical partners and senior leaders.- - Works directly in the SAP system to establish a consolidated , visible forecast for all study product needs ... in critical non-pipeline activities. - Participate in Interactive Voice Response (IVR) System d evelopment and User Acceptance Testing (UAT) for assigned studies .… more
- Merck & Co. (Durham, NC)
- …steam generators, Water-For-Injection generation/distribution, reverse osmosis skids, compressed gas systems )Automated Systems (eg Distributed Control System ... such as boilers, chillers, Cooling towers, air compressors, waste deactivation systems , HVAC, clean steam, WFI.- Develops Standard Operating Procedures (SOPs) and… more
- Merck & Co. (Durham, NC)
- …steam generators, Water-For-Injection generation/distribution, reverse osmosis skids, compressed gas systems )Automated Systems (eg Distributed Control System ... perform routine maintenance tasks, work with and troubleshoot complex process systems , including but not limited to:Process Equipment (eg Filling Machine,… more
- Merck & Co. (Rahway, NJ)
- …release of drug product across assigned program(s) . - Works directly in the SAP system to establish a consolidated , visible forecast for all product s used within ... the efficiency, accuracy, and effectiveness of clinical supply planning processes and systems . - Stay updated on industry trends, regulations, and best practices… more
- Merck & Co. (Omaha, NE)
- …be responsible for installing, maintaining, troubleshooting, and repairing equipment, utility systems , and facility needed for the storage, packaging and shipping of ... troubleshooting and maintaining equipment, performing root cause analysis on system failures and substandard equipment performance, using standard problem-solving… more
- Merck & Co. (Rahway, NJ)
- …in both GMP and non-GMP environment Participate in laboratory computer system validation activities associated with new or upgraded instrumentation or software ... to ensure 21 CFR part 11 ComplianceSupport standardization activities for System Development Life CyclePrepare, review, and approve documentation such as master… 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 ... GMP, and calibration/maintenance proceduresUpdate maintenance procedures to ensure work can be easily integrated with difficult operations schedule.Must be willing… more
- Merck & Co. (Rahway, NJ)
- …assigned studies such as IRT & Microsoft PowerApps. -Works directly in the SAP system to ensure a robust and consolidated forecast for CFGs is maintained. --Report ... and clinical customer relationship management.-Technical Proficiency: familiarity with supply chain systems and software (eg SAP or Oracle) and demand planning… more
- Merck & Co. (Durham, NC)
- …steam generators, Water-For-Injection generation/distribution, reverse osmosis skids, compressed gas systems )Automated Systems (eg Distributed Control System ... perform routine maintenance tasks, work with and troubleshoot complex process systems , including but not limited to:Utility Equipment (eg boilers, chillers, Cooling… 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 ... providing quality oversight over the validation and qualification activities for equipment, systems , computer systems , and processes within a cell therapy… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …OverviewThis position will be responsible for maintenance support and mechanical system operations for cGMP Clinical and Commercial Cell Therapy Manufacturing on ... pipefitting, and millwright activities associated with the related mechanical systems , utilities, and process equipmentPerform minor upgrades and installations of… more
- Merck & Co. (Upper Gwynedd, PA)
- …Software Development, Software Development Life Cycle (SDLC), Strategic Initiative, System Designs, Systems Integration, Tensorflow, Testing, Version Control, ... (eg, MLFlow, Docker, SageMaker or other cloud-based solutions).Familiarity with version control systems (eg, Git), GitHub actions and CI/CD processes to manage model… more
- Merck & Co. (Durham, NC)
- …Site Business Partners.Initiate, Review or Approve changes in the Calibration system (ProCal).Manage approved vendors for calibrations not performed by site ... to ensure appropriate instrument turnover to site.Expand knowledge into other systems , capable of managing change in the pursuit of continuous improvement.Support… 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...to travel up to 10% of the time. (% can change on a case-by-case basis based on the… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …will be part of Manufacturing Excellence team reporting to the Manufacturing Execution Systems Lead and will be responsible for EBR development and administration at ... This individual will support electronic batch record (EBR) updates and system improvements, support applicable process and facility updates, and support… more
