- Legend Biotech USA, Inc. (Raritan, NJ)
- …technical studies, and any associated documentation in support of computer systems validation , equipment, utilities, and facility qualification, process ... data integrity.Key Responsibilities Provide quality and compliance oversight for computer systems validation , process validation , equipment, utilities, and… more
- Merck & Co. (Rahway, NJ)
- …GPV procedure managementSupport trainingProvide business support for pharmacovigilance database systems (eg, review validation documents and execute User ... activities, including (but not limited to) signal detection, prioritization, validation , assessment, and recommendation for actionSignal management statement preparation… more
- Eisai, Inc (Nutley, NJ)
- …area Strong analytical skills and report writing skills Experience with GxP systems including computer system validation and associated regulations, recommended. ... Ability to Travel (approximately 15%)This role is hybrid and requires at least 2 days per week working onsite in our Nutley, NJ office. Eisai Salary Transparency Language:The base salary range for the Director, Clinical Quality Assurance is from… more
- Insmed Incorporated (San Diego, CA)
- …partners.ResponsibilitiesEDC System Design & Development:Lead the setup, development, and validation of EDC systems , including configuration settings, ... EMA, ICH-GCP) and company SOPsPerform user acceptance testing (UAT) and validation of EDC systems to ensure data integrity and accuracyImplement and monitor data… more
- Eisai, Inc (Exton, PA)
- … validation documentation and implement validation plans, and direct validation efforts for automation systems . The position will participate in site ... Primary responsibility will be to maintain the various control systems throughout the pilot plant facility as well as...alarms as well as to alleviate nuisance alarms. Support Validation in their qualification work as well as in… more
- Merck & Co. (Rahway, NJ)
- …Define and implement data standardization rules and practices across multiple source systems . Support the extraction, transformation, and validation of process ... application designed to create a frictionless flow of data from source systems to regulatory documentation.- Under the guidance of dCMC Leadership, the Senior… more
- Merck & Co. (Rahway, NJ)
- …Director Packaging Technical Operations the Director Packaging Distribution, Components and Systems Center of Excellence (COE) is responsible and accountable for ... molecule bulk and primary packaging components and packaging master data and systems .The Packaging Technical Operations organization aims to be an industry leader in… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …planning, and demos with partners.Support MES updates with other Supply Chain Systems (ERP, eLIMs, etc.).Support MES validation activities according to the ... part of MSAT team reporting to the Manufacturing Execution Systems Lead and will be responsible for interfacing with...including but not limited to Tech Support, Process Improvement, Validation , Supply Chain, Operations, QA, Reg CMC, and IT.… more
- Twist BioScience (South San Francisco, CA)
- …integration and analysis using containerized solutionsImplement robust quality control metrics, validation frameworks, and monitoring systems for sequencing data ... NGS and ONT long-read platformsSolve complex computational biology challengesBuild systems that advance genomic research and precision medicineKey Responsibilities:Design… more
- Merck & Co. (Rahway, NJ)
- …post-market commercial manufacturing support. BDSC supports stage 1 & 2 process validation deliverables (2011 FDA process validation guidance) including various ... to internal and external manufacturing sites, manufacturing investigations, process validation , second generation process development and authoring of regulatory… more
- Merck & Co. (Durham, NC)
- …such as boilers, chillers, Cooling towers, air compressors, waste deactivation systems , HVAC, clean steam, WFI.- Develops Standard Operating Procedures (SOPs) and ... Maintenance (PM) plans as requested. Responsible for SAP transactions, validation testing support, supporting root cause investigations and change control… more
- Merck & Co. (North Wales, PA)
- … systems , particularly in process and equipment qualification & validation , root cause analysis, change control, deviation management, and cleaning ... mechanical & electrical knowledge, automation expertise, AutoCAD/SolidWorks competency, equipment validation & qualification, Lean Manufacturing/Six Sigma, GMP, Safety Standards,… 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
- Formation Bio (New York, NY)
- …therapeutics while ensuring these capabilities evolve into robust, production-ready systems .Responsibilities Lead the Platform Science arm of Data Science, building ... product teams to transition proof-of-concept models into scalable, production-ready systems Define technical execution strategy for clinical outcome prediction,… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …initiatives requiring MES enhancements.Coordinate MES updates with other Supply Chain Systems (ERP, eLIMs, etc.).Coordinate and execute MES validation activities ... will be part of Manufacturing Excellence team reporting to the Manufacturing Execution Systems Lead and will be responsible for EBR development and administration at… more
- Merck & Co. (Durham, NC)
- …Maintenance, Safety, Process Development, Technical Services, Utilities, and Validation . Position Description: Durham-Technology consists of the Automation/MES, ... Deviation Management, Manufacturing Technical Operations, Validation , and New Product Technical Transfer Departments.The Associate Specialist - Process Engineer will… more
- Merck & Co. (Rahway, NJ)
- …validation , with a strong understanding of quality management systems and regulatory compliance.Demonstrated technical leadership in injection molding, ... products, with a focus on autoinjectors, prefilled syringes, and other drug delivery systems . The associate director will be a technical subject matter expert on the… more
- Merck & Co. (Rahway, NJ)
- … validation , with a strong understanding of quality management systems and regulatory compliance.Exceptional project management skills and principled verbal and ... products, with a focus on autoinjectors, prefilled syringes, and other drug delivery systems . The director will lead a team of engineers and technical staff to… more
- Merck & Co. (Boston, MA)
- …Collaborate with external vendors supporting target identification, validation , and pre-clinical/non-clinical development to evaluate opportunities, influence ... of tools within our Company's ecosystem and with upstream/downstream systems .Apply industry standards and ontologies to develop FAIR (Findable, Accessible,… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionDirector, Packaging Shipping Systems (Logistics and Distribution Technology)Reporting into the Director Packaging Distribution, Components and ... Systems COE the Director, Logistics and Distribution Technology will...across the network. Deliver the development, design, construction, qualification/ validation and/or initial operation of complex tertiary packaging components… more
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