- 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)
- …- Required Skills: Combination Products, Compliance Packaging, Deviation Management, Engineering Standards, ISO Standard, Management Process , Mechanical ... Job DescriptionThe Associate Director, Engineering , Packaging Commercialization will lead packaging development for...s are robust , packaging processes are efficient, and control strategies are integrated with both upstream and downstream… 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)
- …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)
- …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)
- …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)
- …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
- Merck & Co. (Rahway, NJ)
- …Network Orchestration including: product enhancements, cross-product considerations, process and method technical changes, robustness/quality/ productivity projects. ... alternatives need to be established. Education: Required: Bachelor's degree in Engineering , Science, Supply Chain Management or related field. Preferred: Master's… 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)
- …the Site Strategic Initiatives team. This role will specialize in manufacturing process optimization and provide dedicated engineering expertise related to new ... This individual's primary responsibility will be support of manufacturing process optimization through process modelling, new technology integration,… 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
- 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
- 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
- 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
