- Merck & Co. (Rahway, NJ)
- …Risk assessment, control strategies, process comparability reports, Process performance qualification, and/or regulatory submissions.- CMC RA : ... Validation, Manufacturing Quality Control , Manufacturing Scale-Up, Mentorship, Process Improvements, Project Management, Regulatory Submissions, Risk… more
- Merck & Co. (Rahway, NJ)
- …expected to apply his/her knowledge of product design and development; manufacturing process development, qualification, and validation; and design control and ... experience with deep working knowledge of device, biologic/drug product, and process development including regulatory submission and approval processes.… more
- Merck & Co. (Rahway, NJ)
- …knowledge in QbDRequired Skills: Applied Engineering , Applied Engineering , Capital Management, Change Management, Chemical Process Development, ... Process Improvements, Product Commercialization, Product Lifecycle, Product Management, Regulatory Requirements, Results-Oriented, Social Collaboration, Stakeholder Engagement, Stakeholder Negotiations… more
- Merck & Co. (Rahway, NJ)
- …assessment, control strategies, process comparability reports, Process performance qualification, and/or regulatory submissions.CMC RA: Experience ... customers.Your participation will be instrumental in supporting DS commercialization, process characterization, control strategy development, tech transfer to… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …submissions Understand manufacturing changes to ensure compliance with appropriate change control systems/ process and support regulatory filing strategy ... with a concentration in Chemical, Biochemical, Biomedical or other related Engineering disciplines, Regulatory or pharmaceutical science, or other related… more
- Merck & Co. (Rahway, NJ)
- …Managing Change Requests, People Leadership, Plant Maintenance, Preventative Maintenance Programs, Process Control Systems, Project Management, Regulatory ... (RY) NJ Campus. - This role ensures HVAC systems comply with regulatory standards (eg, FDA, cGMP), maintain optimal environmental conditions for product quality,… more
- Merck & Co. (Rahway, NJ)
- …art scientific methodologies and tools to enable the discovery, development, regulatory approval, manufacturing, and marketing of medical drugs and vaccines for ... Requirement: -MS in Computer Science, Statistics, Applied Mathematics, Life Sciences, Engineering or related analytical field plus 3-7 years experience in multiple… more
- ValSource, Inc. (Rahway, NJ)
- …validation protocols and documents for a variety of utilities, facilities, and process equipment used in the FDA regulated pharmaceutical and biotech manufacturing ... client sites, ensuring that pharmaceutical manufacturing processes and systems meet regulatory and quality standards. This role involves extensive travel to various… more
- Merck & Co. (Rahway, NJ)
- …applying knowledge in drug and device product development, such as manufacturing process development and validation, design control , risk management, material ... strategies for innovative combination products?Join our company's Device Product & Process Development (DPPD) Team, which focuses on the design, development, and… more
- Merck & Co. (Rahway, NJ)
- …Quality Control , Master Batch Records, Material Selection, Pharmaceutical Process Development, Production Planning, Regulatory Compliance, Shift Work, ... be opportunity for technicians to cross-train in other parts of the process including thaw, formulation, visual inspection, and sterile supply. These individuals are… more
- Merck & Co. (Rahway, NJ)
- …Compliance Packaging, Cross-Functional Teamwork, Detail-Oriented, Deviation Management, Engineering Standards, Good Manufacturing Practices (GMP), Management ... Process , Manufacturing Scale-Up, Mentorship, Packaging Engineering , Process Optimization, Risk Management, Root Cause Analysis (RCA), Social Collaboration,… more
- Merck & Co. (Rahway, NJ)
- …Cost Management, Decision Making, Financial Acumen, GMP Compliance, Inventory Control Management, Logistics, Logistics Management, Management Process , Packaging ... relationships with key leaders and stakeholders, namely External Manufacturing, Quality/ Regulatory , Finance, Legal, and Shared Business Services, and other corporate… more
- Merck & Co. (Rahway, NJ)
- …implementing, and optimizing automated laboratory systems to accelerate pharmaceutical process development while ensuring operational excellence and regulatory ... a Senior Scientist to join our Data-Rich Experimentation (DRE) organization, within Process Research & Developing Enabling Technologies (PR&D ET), located in Rahway,… more
- Suburban Propane (Whippany, NJ)
- …We have an exciting opportunity for a **Manager - Renewable Natural Gas Engineering ** to be responsible for overseeing the Engineering function of Suburban ... closely with Suburban's Operations and Construction staff as well as external engineering firms to create new facilities; and manage, oversee, and implement ongoing… more
- embecta (Parsippany, NJ)
- …position is responsible for overseeing document control systems, maintaining regulatory compliance, and driving process improvements across embecta's global ... manuals. + Perform overall document control of engineering design submittals and process reviews. +...+ Ensure timely updates to documentation in response to regulatory changes, internal audits, or process improvements.… more
- SMBC (Jersey City, NJ)
- …documentation. + Build and optimize ETL pipelines and data warehouses for regulatory reporting and business intelligence. + Develop automation tools to streamline ... teams such as Global Market vertical function, Risk management department, Product Control , and Tokyo head office to define and deliver solutions. + Conduct… more
- Arup (Newark, NJ)
- …We are seeking a candidate who brings: . 10-15 years of mechanical engineering design experience, ideally in complex MEP systems. . Professional Engineer (PE) ... for buildings, incorporating sustainability goals. . Bachelor's Degree in Mechanical Engineering required. . PE required; experienced engineer of record preferred. .… more
- SMBC (Jersey City, NJ)
- …**Role Description** This position is a subject matter expert in the Regulatory Reporting Automation for BHC, Branch, Liquidity or Broker Dealer regulatory ... monitoring and evaluating work. This position works closely with Director of Regulatory Reporting Change Management Department to ensure proper review of all work… more
- Unity Technologies (New York, NY)
- …addressing control gaps and audit findings. + Champion automation and process improvements to enhance control efficiency, reduce manual effort, and ... implementation, testing, evidence management, and continuous improvement of technology control environments across relevant compliance mandates, including but not… more
- SMBC (New York, NY)
- …writing and presentation development skills to draft materials related to credit process observations and process and control enhancement opportunities. ... of climate science, Earth system modeling, and statistical analysis. - Familiarity with regulatory guidance, data and model governance process , and industry best… more
