- Merck & Co. (Rahway, NJ)
- …approval(s).Define design input(s)/ output(s) and lead associated combination product design verification plan, protocol(s), and report(s) that demonstrate ... of combination product development experience.Leadership experience of combination product design verification programs and leading activities (eg, strategy/… more
- Merck & Co. (Rahway, NJ)
- …security requirements appropriate for industrial environments. Requirements definition & systems design Lead scoping, requirements definition, and prioritization ... nested BOMs, quality inspection, material handling. Proven track record owning end-to-end product lifecycle for large, complex systems and delivering measurable… more
- Merck & Co. (Rahway, NJ)
- …SME guidance in support of small molecule drug substance and drug product container closure systems including mold qualification and regulatory compliance.- ... Director Packaging Technical Operations the Director Packaging Distribution, Components and Systems Center of Excellence (COE) is responsible and accountable for… more
- Merck & Co. (Rahway, NJ)
- … product engineering.Demonstrated technical leadership in Technology Transfer and Design Transfer for medical device and combination product component ... specific experience in autoinjectors, prefilled syringes, and complex drug delivery systems .Proven expertise in design controls, risk analysis, control… more
- Merck & Co. (Rahway, NJ)
- … product managers and technical leads,-you will help-to design systems , determine functional and non-functional-needs-requirements-and implement them ... Job DescriptionAs a Senior Platform Engineer you will design , deploy, and maintain data platforms, predominantly concentrating on Databricks. - This role involves… more
- Merck & Co. (Rahway, NJ)
- …the product and all phases of outcomes research including design and implementation of retrospective database studies, assessment of patient reported outcomes, ... to meet the value evidence needs of payers, health systems , and clinicians .This includes direct interactions with HTA...with the US Market strategy.- The incumbent contributes to product development and marketing strategies to ensure that … more
- Merck & Co. (Rahway, NJ)
- Job DescriptionDirector, Packaging Shipping Systems (Logistics and Distribution Technology)Reporting into the Director Packaging Distribution, Components and ... Systems COE, the Director, Global Distribution Engineering and Technology,...distribution and logistics of human health Drug Substance, Drug Product and Finished Goods globally.- The Packaging Technical Operations… more
- Merck & Co. (Rahway, NJ)
- …affiliates to obtain in-depth understanding of country specific HTA/reimbursement needs for the product and gain input on research design and implementation of ... to meet the value evidence needs of payers, advisory committees' health systems , and clinicians.The incumbent can generate these plans based on direct interactions… more
- Merck & Co. (Rahway, NJ)
- …for distribution and logistics of human health Drug Substance, Drug Product and Finished Goods globally.-The Packaging Technical Operations organization aims to ... possess deep technical expertise, a strong track record in problem-solving, experimental design and execution, along with leadership skills to shape the technical… more
- Merck & Co. (Rahway, NJ)
- …at the Rahway (RY) NJ Campus. - This role ensures HVAC systems comply with regulatory standards (eg, FDA, cGMP), maintain optimal environmental conditions ... for product quality, and support continuous operations. The ideal candidate...ideal candidate will have strong technical expertise in HVAC design , maintenance, and validation within a highly regulated environment,… more
- Merck & Co. (Rahway, NJ)
- …requiring approximately 50% worldwide travel.Develop and maintain Technical Quality Agreements. Design and build Business Continuity Process and Quality Risk ... and/or quality experience within an FDA, USDA, and/or EU API, Drug Product , Medical Device, or equivalent environment.At least two (2) years of experience… more
- Merck & Co. (Rahway, NJ)
- …submissions and post marketing support.-The incumbent is responsible for the design and maintenance of statistical datasets that support multiple stakeholder groups ... programming point of contact and knowledge holder through the entire product lifecycle.- Primary Activities: Effective analysis and report programming development… more
- Merck & Co. (Rahway, NJ)
- …submissions and post marketing support.The incumbent is responsible for the design and maintenance of statistical datasets that support multiple stakeholder groups ... programming point of contact and knowledge holder through the entire product lifecycle. Primary Activities :Effective analysis and report programming development and… more
- Merck & Co. (Rahway, NJ)
- …knowledge gained. Drive new technology development projects through participation in equipment design and testing as well as preparation, review, and completion of ... supporting compliance investigations and change management. Experience working with Quality systems . Experience working in an environment with an Automation System… more
- FreshRealm (Linden, NJ)
- …hasn't followed a traditional path, or includes alternative experiences. As a **_Senior Product Manager for Supply Chain and Operations_** , you will scope and ... deliver the technical product vision for our fulfillment lines and warehouse management systems . You will define the success metrics for the program and your… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …of Manufacturing Science and Technology team reporting to the Manufacturing Execution Systems Lead and will be responsible for providing project management support ... management office to enable robust EBR and IT solutions for production of product to patients. This individual will also be responsible for gaining the necessary… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …robust training, regulatory compliance, team readiness, and processing of product prior to release to patients.Schedule: Mon-Fri, 2nd ShiftKey Responsibilities ... an aseptic manufacturing facility, preferably in training/system applications, quality systems , or learning management systems .Knowledge of cGMP regulations… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …of a risk-based quality management process fully embedded through trial design , execution and submission including all vendor managed activities with the ... with the Sr Director, Medical Affairs QA to conduct quality reviews of product profiles, ensuring thorough management review of all quality and compliance topics,… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …be responsible for providing engineering support for building automation and controls systems in the cGMP Clinical and Commercial Cell Therapy Manufacturing plant. ... issues, deviations, corrections, remediation and improvement efforts of automation and controls systems for facility, equipment, systems and processes in support… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …and performance of all engineering operations across Raritan Carvykti drug product manufacturing. This role ensures that the manufacturing building, relevant campus ... infrastructure, equipment, and systems support business goals and comply with safety, regulatory, and sustainability standards. This position is a key member of the… more
