- Integra LifeSciences (Plainsboro, NJ)
- …(ECR/ECO) and Engineering Drawings. + Oversee projects to implement statistical process control (as necessary), analyze and trend existing process ... process engineering . + Experience with Quality System Regulation, Design Control and Process Validation guidelines, Engineering Change Controls, ISO,… more
- Merck & Co. (Rahway, NJ)
- … Engineering , Packaging Equipment, Packaging Processes, Pharmaceutical Packaging, Process Optimization, Regulatory Requirements, Risk Management, Root Cause ... and processes including packaging equipment design & development, ensuring packaging process control and efficiency and providing on-going packaging and… 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)
- …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)
- …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
- 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)
- …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)
- …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)
- …Communications, Personal Initiative, Pharmaceutical Sciences, Pharmacology, Pilot Plant Operations, Process Engineering , Process Optimization, Product ... mission will be accomplished by: 1) Enabling robust formulation and process development with flexible physical and digital infrastructure; 2) Delivering compliant,… more
- Merck & Co. (Rahway, NJ)
- …Development: Build, lead, and develop a centralized MDM team (data stewards, process leads, data quality analysts) within OpEx responsible for master data ... Ensure master data practices comply with internal policies, external regulatory requirements, and audit expectations. Education & Experience :Bachelor's degree… 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)
- …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
- 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
- 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)
- …standards and GMP regulations.Conduct analytical testing of raw material/utility, in- process , or final product samples submitted to the QC laboratories.Perform ... quality counterparts that include Quality Assurance, Manufacturing Operations, and Analytical/ Process Development.Job duties performed require routine exposure to and… 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
