- Merck & Co. (Rahway, NJ)
- Job DescriptionDevice Development Associate Principal Scientist - Development Strategy, Design Controls (Associate Director Equivalent) Our company's Device ... for leading and implementing medical device and combination product design controls for both new products and...expected to apply his/her knowledge of product development and design control principles to positively support and… more
- Merck & Co. (Rahway, NJ)
- … design and development, manufacturing process development, qualification, validation, and design control and risk management techniques to positively support ... including engineering design , engineering analysis and testing, medical device design controls , risk management, test method/ fixture development, design… more
- Merck & Co. (Rahway, NJ)
- …develop robust assembly specifications with sound justification.Understand medical device/delivery system product design , functionality, storage, and handling ... Job DescriptionAs a Senior Engineer in Device Design and Process Development group, you will be...commercial assembly equipment and processes for medical devices/drug delivery systems . Reporting to the Director responsible for this area,… more
- Merck & Co. (Rahway, NJ)
- …autoinjectors, prefilled syringes, and complex drug delivery systems .Proven expertise in design controls , risk analysis, control strategies, design ... and requirements for commercializing new products.Technical Expertise:Utilize extensive experience in design controls , device transfer, control strategies… more
- Merck & Co. (Rahway, NJ)
- …and working in a highly regulated industry.Experience with business process mapping and system design for workflow management is an asset.Strong aptitude for ... Documentation, Testing, Implementation, Deployment and Hypercare phases.Facilitate and oversee the System Support Model for systems within remit including:… more
- Twist BioScience (South San Francisco, CA)
- …Cycle (SDLC) for our custom MES, including detailed requirements gathering, system design , coding standards, development, rigorous testing, validation, ... culture, fermentation, purification, aseptic filling, media/buffer prep, etc.) and associated automation/ control systems (SCADA, DCS, PLC, HMI) from a software… more
- Repligen (Clifton Park, NY)
- …linear motion, cartesian motion (ie, pick & place, measurement, load, and unload). Controls - vision systems , PLC, sensors, pneumatics, hydraulics, electronics, ... single-use state-of-the-art single use components and innovative storage and transfer systems that optimize fluid transfer and reduces the number of connections… more
- Repligen (Waltham, MA)
- …and supporting strong analytical approach with teams across the organization. Internal Controls & Compliance: Design , implement, and maintain effective internal ... System Optimization:Drive continuous improvements in accounting processes and systems to enhance efficiency and accuracy.Implement financial systems … more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …cross-functionally across Technical Operations and interface with IT to drive the design and implementation of new system updates for cell therapy ... 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
- Novo Nordisk Inc. (Durham, NC)
- …in relevant areas Own self development & initiative to understand the site process control systems , data management systems , and differing data sources (PCS, ... systems and associated applications required Proven expertise in system interfacing and integration required Experience in Project Management, Batch Reporting,… more
- Merck & Co. (Rahway, NJ)
- …secure solutions through identifying effective security requirements and secure design principles that support security, scalability, and efficiency in ... professional written and verbal communication skills.Experience with cloud security design , implementation, and monitoring.Strong interpersonal communications skills and worked… more
- Merck & Co. (Rahway, NJ)
- …build a high-performance engagement model with DSCS.- Assist with strategic design and user-centric problem discovery efforts.Collaborate with DSCS Digital Teams to ... our Company's manufacturing division.Understanding of the existing IT portfolio of systems and products.- Understanding of the external technology landscape and the… more
- Merck & Co. (Rahway, NJ)
- …Process Improvements, Protein Purifications, Regulatory Submissions, Social Collaboration, Statistical Design of Experiments (DOE), Statistical Process Control ... substance processes. Your insights will be crucial for establishing an integrated control strategy suitable for commercialization and licensure for the products in… more
- Repligen (Rancho Dominguez, CA)
- …Act as a Subject Matter Expert for TFF and other bioprocessing manufacturing systems . Lead projects in equipment design , tech transfer, process validation, and ... device manufacturing, with deep expertise in Tangential Flow Filtration (TFF) systems , process engineering, and equipment qualification, preferably within GMP or ISO… more
- Eisai, Inc (Nutley, NJ)
- …independently carry out routine, complex and for-cause audits Knowledge of data integrity controls and systems quality for clinical area Strong analytical skills ... The Director, Clinical Quality Assurance position is responsible for design , delivery and execution of the North America (NA)...and report writing skills Experience with GxP systems including computer system validation and associated… more
- Novo Nordisk Inc. (West Lebanon, IN)
- …and timely assessments associated with change control activities Ensures change control activities for systems are completed in a manner in compliance ... to one of our manufacturing suites. Responsible for assisting with design and implementation of manufacturing processes, instrumentation and equipment start-ups from… more
- BioAgilytix (Durham, NC)
- …from core systems (LabVantage LIMS, ERP) into a centralized data repository. Design and implement the architecture for a scalable data hub, using cloud platforms ... governance framework, with hands-on responsibility for data quality, access control , and compliance protocols.Define standards, build quality assurance processes,… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …productivity improvements.Support manufacturing investigations, support and manage change controls , and maintain permanent inspection readiness and actively support ... improvements and efficiencies within cell therapy Technical Operations.Support organizational design updates, operations organization build, operations ramp-up of commercial… more
- Repligen (Waltham, MA)
- …Internal and External Auditing, Nonconforming Materials, CAPA, Validation, Change Controls , and other product life cycle management activities.Partner with ... revise procedures, practices, and specifications; provide training on quality system and procedures.Maintain strong cross-functional quality focus; build, maintain,… more
- Twist BioScience (South San Francisco, CA)
- …environments.Collaborate with DevOps teams to maintain monitoring, logging, and alerting systems for pipeline reliability and performance. Design and implement ... will combine genomics expertise with strong production engineering skills to design and implement robust, scalable computational pipelines for large-scale NGS data… more
