- Sunrise Systems Inc (Summit, NJ)
- … Systems Familiar with the development of CSV documentation ( Validation Plans, Requirements, Design / Configuration Specifications, Test Scripts [IQ/OQ/PQ/UAT], ... of Electronic Batch Records (EBR) and Review by Exception (RBE) and Recipe Authoring/ Validation . Ability to work extended hours or a modified work schedule to assist… more
- Novo Nordisk Inc. (Durham, NC)
- … validation protocols preferred Experience in managing projects preferred Experience with electronic validation systems (TIMS) and SAP PM and QM module a plus ... of people around the world. In NC, we operate three pharmaceutical manufacturing facilities that are responsible for fulfilling different steps in our injectable… more
- Merck & Co. (Durham, NC)
- …and maintaining the automation systems in compliance with cGMPs. The Manufacturing Automation Sr. Specialist must actively support, participate and embrace ... Description: Senior Specialist , Manufacturing Automation The Senior Specialist Manufacturing Automation person is primarily responsible for supporting… more
- Merck & Co. (Rahway, NJ)
- …utility systems and associated infrastructure.- Responsibilities of the Specialist - Manufacturing Automation include the following:Site Operations (GWES) ... that provides both technical and project management responsibility. The Specialist - Manufacturing Automation position will report...:- The Automation specialist will help to support several automation … more
- Aequor (Seattle, WA)
- …and domestic regulatory requirements. Knowledge of manufacturing quality ( manufacturing , packaging, facilities, critical systems , validation , etc.). ... cross-functionally Position Summary: The Quality Assurance Document Control (QADC) Associate Specialist supports the cGMP Document Control operations for the Client… more
- Merck & Co. (Durham, NC)
- …limited to: Directly supports routine production as an administrator for manufacturing systems , in partnership with maintenance, technical operations, ... is a member of the Automation team responsible for the support of process control systems used in manufacturing operations located in Durham, NC.- We use a… more
- Novo Nordisk Inc. (Durham, NC)
- …approval of validation activities associated with minor changes to existing systems . Performs archiving duties & QA presence & process confirmation on shop ... required Understanding of the Batch Review Processes required Understanding of validation preferred Understanding of quality management systems required… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …collaborative team setting with quality and operations counterparts that include Manufacturing Operations, Quality Assurance, Engineering and Validation , Quality ... Biotech is seeking a QA Warehouse Incoming Raw Material Specialist as part of the Quality team based in...receipt, incoming inspection and release of materials required for manufacturing and release of patient material/final product of CAR-T… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …for working with groups to provide start-up, commissioning, and qualification/ validation support of instrumentation and systems including on-the-floor ... in the treatment of multiple myeloma. Legend Biotech is seeking a Metrology Specialist as part of the Maintenance & Metrologyteam based in Raritan, NJ. Role… more
- Sunrise Systems Inc (Seattle, WA)
- …and domestic regulatory requirements. Knowledge of manufacturing quality ( manufacturing , packaging, facilities, critical systems , validation , etc.). ... cross-functionally Position Summary: The Quality Assurance Document Control (QADC) Associate Specialist supports the cGMP Document Control operations for the Client… more
- Sunrise Systems Inc. (Summit, NJ)
- …and domestic regulatory requirements. Knowledge of manufacturing quality ( manufacturing , packaging, facilities, critical systems , validation , etc.). ... cross-functionally Position Summary: The Quality Assurance Document Control (QADC) Associate Specialist supports the cGMP Document Control operations for the Client… more
- Dexian - DISYS (Bothell, WA)
- The MES Recipe Engineer and Validation Specialist role will deliver electronic batch record (EBR) configuration and validation in the Emerson Syncade ... and modification.Execute development and implementation of new capabilities across the Manufacturing systems based on requirements, specifications, and developed… more
- On-Board Companies (Bothell, WA)
- …PURPOSE AND SCOPE OF POSITION (Position Summary):The MES Recipe Engineer and Validation Specialist role will deliver electronic batch record (EBR) configuration ... and validation in the Emerson Syncade Manufacturing Execution...Execute development and implementation of new capabilities across the Manufacturing systems based on requirements, specifications, and… more
- The Bartech Group Inc (Marshall, MI)
- …are powered by Impellam Group, a connected group providing global workforce and specialist recruitment solutions. Our client has engaged us to assist them in hiring ... support to all areas (Engineering - advanced, program, or development, Manufacturing , Commercial, Quality, etc.) where controls engineering expertise is required,… more
- United Therapeutics (Silver Spring, MD)
- …For the _Senior Validation , Engineer_ level: Working knowledge of target systems , including computerized information systems , manufacturing control ... diseases, and other orphan diseases. **How you'll contribute** The Senior Validation Specialist or Engineer, Equipment will perform activities independently… more
- Unither Pharmaceuticals (Rochester, NY)
- Quality Specialist - Development & Validation Who we are? We are a French pharmaceutical industrial group, recognized for making affordable healthcare products ... employees. Your role Reporting to the Quality Assurance Manager, The Quality Specialist (Development and Validation ) assists and supports the organization with… more
- J&J Family of Companies (Raritan, NJ)
- …Family of Companies, is recruiting for a **Quality Assurance Equipment/Computer System Validation Specialist II-CAR-T Manufacturing .** This position will be ... Quality Assurance Equipment/Computer System Validation Specialist II - 2406169574W **Description**...+ Assess, Review, and approve change controls related to manufacturing , laboratory and facility systems . + Strive… more
- Unither Pharmaceuticals (Rochester, NY)
- Validation Specialist Who we are? We...more than 2000 employees. Since 2013, our site Unither Manufacturing LLC. based in Rochester (NY), specializes in the ... Your role Reporting to the Senior Manager, Engineering, JOB SUMMARY: Manages validation projects or multiple validation project activities under limited… more
- Glenmark Pharmaceuticals Inc., USA (Monroe, NC)
- Sr. Validation Specialist , Pharmaceuticals- Monroe, NC (MULTIPLE-POSITIONS AVAILABLE) Department: Validation Location: Monroe, NC START YOUR APPLICATION ... (https://apply.hrmdirect.com/resumedirect/ApplyOnline/Apply.aspx?req\_id=3032926&source=3032926-CJB-0) Glenmark is actively seeking a Senior Validation Specialist to join the growing team… more
- Regeneron Pharmaceuticals (Troy, NY)
- … manufacturing standards policies and procedures. The day to day of a QA Validation Specialist could include, but are not limited to, the following: + ... including + This team works closely with our Drug Manufacturing and Packaging Engineers to make sure our products...of relevant experience for each level: + Assoc. QA Validation Specialist : 0 - 2 years… more
