- Novo Nordisk Inc. (West Lebanon, IN)
- …practice & understanding of change control processes Expert understanding of validation/ system development life cycle approach Basic computer skills including ... Reports to: Sr. Operational Excellence Manager plus additional interfacing with Manager of Automation Engineering and IT Department. Number of subordinates… more
- Exela Pharma Sciences, LLC (Lenoir, NC)
- Position Summary The Manager of Automation Engineering leads Automation Engineers and contractors responsible for instrumentation and controls of manufacturing ... Automaton Projects including the definition of the scope of work and specification development . Hands-on ability to develop robust systems and workflows that… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …reward hard work and dedication with opportunities for continuous learning and personal development . Are you ready to maximize your potential with us? The Position ... The Senior Manager , Commercial Insights & Analytics, provides insights and analytics...guide Novo Nordisk on portfolio, franchise, and brand strategy development and execution. This individual primary role will be… more
- Aequor (New Brunswick, NJ)
- …digital capabilities and solutions for all areas of Chemical Process Development (CPD) including engineering technology, sterile product development ... , oral product development , material science and engineering , laboratory operations, device development and strategic...documentation is expected. Able to function as a project manager for multiple projects with smaller scope. Able to… more
- Merck & Co. (Durham, NC)
- Job DescriptionThe role of Operations Manager at our Company's Durham facility is a manufacturing leadership role. The individual in this role must provide ... to reliably support customer demand (including hiring as needed, employee development , routine 1:1 meetings and coaching, recognition, and performance management).… more
- Exela Pharma Sciences, LLC (Lenoir, NC)
- …to Laboratory Working StandardsSupport validation and production engineers in development of metrological specifications for new equipmentDevelop control charts and ... to develop, document, and implement new measurement methods and test systems .Demonstrated knowledge of programming languages in support of instrument automationGreat… more
- Catalent (St. Petersburg, FL)
- …Labels; all equipment IQ/OQ/PQ documents regarding equipment, utilities, and computer systems ; b) process improvement projects and Product Development Projects; ... QA Product Manager Position SummaryThe QA Product Manager ...trend analysis to eliminate future problems. Participates in Product Development /Validation/ Engineering project meetings to provide Quality Assurance… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …areas centered around rare diseases and immune disorders. Summary The Regulatory Data Manager will be a key member of the Global Regulatory Affairs (GRA) Process ... facilitate consistency and quality of data across key Daiichi Sankyo regulatory systems . This includes defining regulatory data standards, data quality rules and… more
- Novo Nordisk Inc. (West Lebanon, IN)
- …increase efficiency of existing operational capacity. Responsibilities include team development , delivery of the associated project portfolio, status reporting, ... operations, including manufacturing optimization improvements and related cross functional Engineering /CAPEX projects, will give a solid grounding for incumbent in… more
- Exela Pharma Sciences, LLC (Lenoir, NC)
- …Brownfield /Greenfield Site Experience is a plus Must understand the entire development process through engineering program and project management, conceptual ... various projects. The Project Engineer will work directly with the Engineering team, Operations, Maintenance, and Manger of Project Management. Job Responsibilities:… more
- Exela Pharma Sciences, LLC (Lenoir, NC)
- …for the validation program, Policies and SOPs and other master documentsSupport Engineering and Manufacturing in the development of critical process parameters ... the validation team in the establishment and maintenance of validated systems . Coordinate technology transfer activities in support of commercialization. Serve as… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …in the treatment of multiple myeloma. Legend Biotech is seeking Operations Manager - Investigations and Compliance as part of the Technical Operations team based ... and batch record execution. This individual will be involved in computerized systems such as Track Wise, Learning Management, Electronic Batch Record, and support… more
- Novo Nordisk Inc. (Boulder, CO)
- …, API Manufacturing. The Technical Team Lead works with Chemical Development , Analytical Services, Engineering , Facilities, EH&S, Program Management and ... a new laboratory completed in 2021 to support analytical and process development , the CMC team works alongside Quality, Regulatory, Technical Operations and RNAi… more
- Novo Nordisk Inc. (Durham, NC)
- …schedules Operate as automation resource on projects that involve process control systems Responsible for own self development & initiative to understand ... years engineering experience in process-based manufacturing, utility, &/or packaging systems required Minimum of three (3) years engineering experience in… more
- Merck & Co. (Rahway, NJ)
- …experienceRequired Education: Bachelors Degree in Computer Science, Information Systems , Engineering , or equivalent field required.#eligibleforerp NOTICE ... Engineer will be responsible for evaluating, recommending, implementing and supporting systems in the manufacturing and lab print environment including label and… more
- Merck & Co. (Ames, IA)
- …throughout product/BOM changes, obsolescence, and/or materials due to new product development .Setup & maintain material master system planning parameters.Supply ... critically analyze and solve problems.Planning and scheduling of pre-license serials, engineering batches, and field safety trial batches in production in… more
- Merck & Co. (Durham, NC)
- …units Assist in the identification, development , and implementation of new systems which enhances the operation and/or engineering processes. Quality & ... generation/distribution, reverse osmosis skids, compressed gas systems ) Automated Systems (eg Distributed Control System (DCS), Programmable Logic… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …records, forms, and support and manage change controls. Work closely with Operations Manager to help oversee the development of production personnel, provide ... team, in a manner consistent with safety policies, quality systems , and cGMP requirements. Support manufacturing investigations, create/revise operational… more
- Catalent (St. Petersburg, FL)
- …The Department has the responsibility for Quality aspects related to Quality Systems , Finished Product Batch Release, and Change Control.II. Basic Function: This ... schedule for the QA Specialists.Provides feedback to QA Supervisor and Manager on performance of QA Specialists.Responsible for actively identifying compliance… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …or material handling tasks in a backup role, as needed. Updates supervisor/ manager of work status or problems with recommendations for improvement or correction. ... compliance. Perform tasks in a manner consistent with the safety policies, quality systems and cGMP requirements. Other duties will be assigned, as necessary. Key… more
