- 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
- 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)
- …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)
- …Maintenance Supervision, Manufacturing Support, Occupational Safety and Health, Pharmaceutical Process Engineering , Prioritization, Regulatory Audits, ... Ops Engineering ). The role ensures reliable, compliant operation of process automation and OT/IT systems that enable formulation, filling, and support activities… 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 ... Good Manufacturing Practices (GMP), Leadership, Leading Project Teams, Management Process , Manufacturing Compliance, Manufacturing Methodologies, Materials Engineering ,… 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)
- …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)
- …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)
- …Immunochemistry, Interpersonal Relationships, Manufacturing Processes, Manufacturing Quality Control , Microbiology, Molecular Microbiology, Physiology, Process ... components, and critical supply items to ensure conformance to appropriate regulatory and company requirements. In support of clinical supply manufacture and/or… 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)
- …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)
- …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
- 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)
- …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
- 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
- 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
- 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
