- 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 ... Good Manufacturing Practices (GMP), Leadership, Leading Project Teams, Management Process , Manufacturing Compliance, Manufacturing Methodologies, Materials Engineering ,… 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)
- …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)
- …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)
- …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)
- …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
- Arup (Newark, NJ)
- …We are seeking a candidate who brings: . 10-15 years of mechanical engineering design experience, ideally in complex MEP systems. . Professional Engineer (PE) ... for buildings, incorporating sustainability goals. . Bachelor's Degree in Mechanical Engineering required. . PE required; experienced engineer of record preferred. .… 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
- Organon & Co. (Jersey City, NJ)
- …systems/processes are executed in a manner to provide visibility to accurate regulatory information to enable proper product control . Ensures appropriate ... **Job Description** **The Position** The Principal Scientist (Director) Regulatory Chemistry, Manufacturing and Controls is responsible for Regulatory Chemistry… 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
- SMBC (Jersey City, NJ)
- … requirements into implementable data controls + Ensure data quality compliance, and control for various financial regulatory reports according to company policy ... data experienced associate who mainly focuses on for data quality over financial regulatory reporting data attributes/elements to make sure that the regulatory … more