- 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)
- …in media/solution development and chemistryHigh-throughput experimentation, automation, and process control .Knowledge of microbial fermentationCell culture ... biologics in various stages of clinical development, as well as process characterization and regulatory filings for successful commercialization.Improve upstream… 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)
- …complex drug delivery systems.Proven expertise in design controls, risk analysis, control strategies, design verification testing, and process validation, with ... Good Manufacturing Practices (GMP), Leadership, Leading Project Teams, Management Process , Manufacturing Compliance, Manufacturing Methodologies, Materials Engineering ,… 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
- Legend Biotech USA, Inc. (Raritan, NJ)
- …management, resource planning, and fiscal awareness is preferred.Provide technical expertise of Change Control process as well as oversight of the MES team to ... while liaising with other functions including but not limited to Tech Support, Process Improvement, Validation, Supply Chain, Operations, QA, Reg CMC, and IT. This… more
- Merck & Co. (Rahway, NJ)
- …You will operate at the intersection of executive strategy, software delivery, control systems engineering and shopfloor operations - shaping the technical ... regulatory requirements; manage risks from integrations and on-prem/edge control systems. Collaborate with Infrastructure, Cybersecurity and Architecture teams to… 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
- Legend Biotech USA, Inc. (Raritan, NJ)
- …responsibilities for supervising the operation and workflow of the quality control microbiology laboratories in support of cell therapy manufacturing. This includes ... cGMP and safety) of associates within the department.Raw material, in- process , environmental/utility, and product release testing.Scheduling of daily activities for… more
- Merck & Co. (Rahway, NJ)
- …documents, eg eTMFAssist with eTMF reconciliationExecute eTMF Quality Control PlanUpdate manuals/documentsDocument proper destruction of clinical supplies.Prepare ... Investigator trial file bindersObtain translations of documents Regulatory & Site Start-Up responsibilities: Collaborate with other country roles to: In a timely… 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
- Legend Biotech USA, Inc. (Raritan, NJ)
- …accurate budgeting, forecasting, and cost tracking.Ensure compliance with internal control processes, GxP standards, and regulatory requirements.Maintain ... process improvements, and risk mitigation.Directly support internal audits, regulatory inspections, and procurement-related documentation.Make recommendations for supplier selection… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …around validation and comparabilityIndustry leading knowledge in technology transfer, process comparability, CMC regulatory guidelines and manufacturing in ... analytics scope in support of the approved Carvykti commercial process . At a technical level, the candidate will be...that ongoing manufacturing processes are in a state of control and, additionally, adhere to guidelines established for CPV.… more
- Merck & Co. (Rahway, NJ)
- …diversity, equity, and inclusion. Stay updated on the scientific, industry and regulatory landscape, actively publish and engage with the scientific community to ... Experience, Skills, and Competencies: Stay updated on the scientific, industry and regulatory landscape, actively publish and engage with the scientific community to… 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
- 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)
- …Conflict Resolution, Cross-Functional Teamwork, Customer-Focused, Design Control Process , Ergonomics Consulting, Human Factor Engineering , Human Resource ... Staff, Negotiation, Neuropsychology, Patient Safety, Post Marketing Surveillance, Prioritization, Process Engineering , Product Lifecycle, Product Lifecycle Management… more
- Integra LifeSciences (Princeton, NJ)
- …functional strategy on matters including core capabilities, product quality, design control processes, resource development and utilization, and engineering ... DESCRIPTION** The Senior Manager of the Tissue Technology (TT) Design Assurance Engineering department is responsible for developing Design Assurance Engineering … more
- Integra LifeSciences (Princeton, NJ)
- …and document control processes. Identify and implement efficiencies for continual process improvement and ongoing compliance + Serve as business process ... advance patient outcomes and set new standards of care. The Sr. Manager, Document Control and Training is responsible for leading the Corporate Document Control … more
- iconectiv (Bridgewater, NJ)
- …resilience Ensure support activities meet audit/compliance requirements, including access control , logging, and data handling per customer/ regulatory standards ... in shift Responsible for the effective implementation of the Incident Management process and ensuring that incidents are managed and reported in accordance with… more
