- Aequor (Framingham, MA)
- …encompasses temporary, support to be the lead point of contact for the shipping validation program during a leave period for the primary program owner. This will ... design of transport qualification strategies, reviewing and approving transport validation deliverables and accountability for on-time delivery of transport… more
- 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
- Legend Biotech USA, Inc. (Raritan, NJ)
- …in the treatment of multiple myeloma.Legend Biotech is seeking Director of Manufacturing Execution System as part of the Global MSAT team based in Raritan, NJ. Role ... OverviewThe Director of Manufacturing Execution System (MES) will be part of Manufacturing Science and...organization. Role will work collaboratively with Operations, IT QA, Validation , Reg CMC to deliver on-time, on-budget and right-first-time… more
- CHRISTUS Health (Gregory, TX)
- …suitesA teaching facility in affiliation with the Texas A&M University System Health and Science Center College of MedicineAccredited Chest Pain CenterAccredited ... through successful completion of the designated organizational entry competency validation and a Critical Care Department-specific competency validation… 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
- 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... in their qualification work as well as in validation maintenance activities. Maintain all automated system … 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)
- …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
- Insmed Incorporated (San Diego, CA)
- … System Design & Development:Lead the setup, development, and validation of EDC systems , including configuration settings, integration with ... (eg, FDA, EMA, ICH-GCP) and company SOPsPerform user acceptance testing (UAT) and validation of EDC systems to ensure data integrity and accuracyImplement and… 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
- L3Harris (North Chili, NY)
- …cyber domains in the interest of national security.Job Title: Sr. Assoc, Systems EngrgJob Code: 24969Job Location: Rochester, NYJob Schedule: 9/80 - Employees work ... tasked with the analysis and design of tactical radio based communication systems . Team responsibilities include support and creation of initial concepts, contribute… more
- Aequor (Minneapolis, MN)
- Job Title: Vendor Management System (VMS) Analyst - Temporary Contingent Worker Assignment Length: November 2025 - May 2026 ( 7 months , with potential for ... MN ( HQ); role is remote eligible Job Title: Vendor Management System (VMS) Analyst Location: Remote Duration: 06 Months Shift: 8am-4pm (M-F)Job Description:… 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)
- …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
- 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. (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
- 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. (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. (Boston, MA)
- …Development, Stakeholder Engagement, Stakeholder Relationship Management, Strategic Planning, System Designs, Systems Development Lifecycle (SDLC)Preferred ... discovery platforms. Collaborate with external vendors supporting target identification, validation , and pre-clinical/non-clinical development to evaluate opportunities, influence their… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …therapy manufacturing process design qualification, vendor evaluation, and enterprise system interface engineering support for GMP manufacturing of engineered ... user requirements, functional requirement specifications, qualification protocols, enterprise or system interface, process development reports, and provide technical assessments,… more
