- 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
- 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
- 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
- Legend Biotech USA, Inc. (Raritan, NJ)
- …in a GMP Commercial Facility.Experience with Asset Change Control , Process /System Improvement, Asset Lifecycle activities/documentation.Excellent knowledge ... to meet clinical and commercial demand.RequirementsBachelor's Degree - Preferably in Engineering or Life Sciences.Minimum 10 years of Project Management experience… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionDir, Engineering - Director, Assembly and Packaging Platform Technical LeadershipReporting into the Executive Director Packaging Technical Operations ... development and technology teams, supply chain, operations, quality, analytical, regulatory , and project leaders. The successful candidate will demonstrate ownership… 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)
- …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)
- …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
- Merck & Co. (Rahway, NJ)
- …Risk assessment, control strategies, process comparability reports, Process performance qualification, and/or regulatory submissions. CMC RA : Experience ... Validation, Manufacturing Quality Control , Manufacturing Scale-Up, Mentorship, Process Improvements, Protein Purifications, Regulatory Submissions, Technical… 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 ... alignment with the company's business goals, and quality and regulatory compliance.-Essential Duties and Responsibilities: Strategic Leadership and Project… more
- Merck & Co. (Rahway, NJ)
- …external partners and suppliers.Proven expertise in design controls, risk analysis, control strategies, design verification testing, and process validation, with ... alignment with the company's business goals, and quality and regulatory compliance.-Essential Duties and Responsibilities:Utilize extensive experience in design… 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)
- …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)
- …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)
- …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
