- 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)
- Job DescriptionThe Principal Scientist, Process Control and Data Analytics will be responsible for leading a team focused on developing and implementing product ... control strategies, statistical analysis, and advanced statistical methods for...across processes end to end, analyzing tests methods and controls , to generate a comprehensive assessment of product performance.-… more
- Merck & Co. (Austin, TX)
- …and REST APIs.Participate in test planning, safety validation, change control , and rollback design .Document technical implementations, integration patterns, ... & AI team. This is not a traditional automation role-you will help design and deliver the next generation of cybersecurity systems through secure, intelligent… 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)
- Job DescriptionAs a Senior Engineer in Device Design and Process Development group, you will be part of our Research & Development team that designs and develops ... equipment to enable development of product specific processes and controls with a focus on DFM/DFA principles.Understanding of autoinjector/parenteral/pre-filled… more
- Merck & Co. (Rahway, NJ)
- …toward future-ready systems and modern data architectures. Primary Activities Design and develop interactive dashboards, reports, and visualizations using enterprise ... to ensure scalable and efficient data models and pipelines.Use GitHub for version control of scripts, data models, and BI artifacts to ensure collaboration and code… more
- Merck & Co. (Rahway, NJ)
- …& AI team and the broader cybersecurity stack.Ensure governance, safety controls , and enterprise readiness of all automation pipelines.Collaborate with the AI ... Requirements: 10%Flexible Work Arrangements:RemoteShift:1st - DayValid Driving License:NoHazardous Material(s):n/aRequired Skills: Design Applications, Information Security, Security Operations, SLA Management, Software… more
- Merck & Co. (Rahway, NJ)
- …operations. The ideal candidate will have strong technical expertise in HVAC design , maintenance, and validation within a highly regulated environment, combined with ... and other regulatory requirements.Lead the operation of the site BAS and HVAC control systems. Manage the development and oversight of site operations through data… more
- Merck & Co. (Rahway, NJ)
- …Cell Culture, Manufacturing Scale-Up, Mentorship, Process Characterization, Process Control , Process Design , Process Optimization, Regulatory Submissions, ... will be instrumental in supporting DS commercialization, process characterization, control strategy development, tech transfer to internal and external manufacturing… more
- Merck & Co. (Rahway, NJ)
- …expertise to optimize and fully characterize the enzyme manufacturing process control strategy across different scales.The successful candidate will play a pivotal ... and utilizing Quality Risk Management methodologies and tools for statistical design of experiments. This role involves hands-on experimentation at the laboratory… 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)
- …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
- Twist BioScience (South San Francisco, CA)
- …for our custom MES, including detailed requirements gathering, system design , coding standards, development, rigorous testing, validation, deployment, and ... Process Development, and Regulatory Affairs teams to define MES requirements, design seamless integrations with other enterprise systems (eg, ERP, LIMS, QMS),… more
- Repligen (Waltham, MA)
- …and supporting strong analytical approach with teams across the organization. Internal Controls & Compliance: Design , implement, and maintain effective internal ... controls over financial reporting (ICFR) in compliance with Sarbanes-Oxley (SOX) requirements.Ensure compliance with accounting standards and regulatory requirements, including SEC filings and tax regulations for multinational operations.Coordinate with… more
- Novo Nordisk Inc. (West Lebanon, IN)
- …to one of our manufacturing suites. Responsible for assisting with design and implementation of manufacturing processes, instrumentation and equipment start-ups from ... development and implementation of procedural or automation improvement changes Participate in design and hazard reviews of plant expansions or process changes and… 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 (Clifton Park, NY)
- …motion, cartesian motion (ie, pick & place, measurement, load, and unload). Controls - vision systems, PLC, sensors, pneumatics, hydraulics, electronics, relays, ... will" employment relationship.Skills and Competencies Lean ManufacturingCAD (Computer Assisted Design ) Design of tools, fixtures, and equipmentMachining processes… 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 ... Management, Business Process Improvements, Business Strategies, Business Technology, Change Controls , Computer Technical Support, Cost Management, Financial Management, GMP… more
- BioAgilytix (Durham, NC)
- …governance framework, with hands-on responsibility for data quality, access control , and compliance protocols.Define standards, build quality assurance processes, ... integrity to meet regulatory requirements, including HIPAA, GxP, GDPR, and FIRPA. Design data quality KPIs and implement initial quality checks independently,… more
- Merck & Co. (South San Francisco, CA)
- …implementing, and optimizing GenAI approaches to streamline the creation and quality control (QC) of regulatory submission documents. The candidate will be part of ... key collaborator with principal investigators and lab-based colleagues.Primary Responsibilities: - Design , develop, and deploy GenAI models to automate the… more
