- Tris Pharma (Monmouth Junction, NJ)
- …honest communications to help support individual and team success. Our Method Validation Department located in our Monmouth Junction, NJ headquarters has an ... immediate need for an experienced Method Validation Scientist II.Summary: Under supervision, performs laboratory analyses of raw materials, in process (IP), finished… more
- Merck & Co. (Lower Gwynedd, PA)
- …operational and informational technology systems .Apply deep expertise in the computer system validation process of lab equipment, including the conduct of ... a talented, organized, and innovative leader to lead our Laboratory Operations and System Validation team. The successful candidate will coach and mentor staff,… more
- Raytheon (Aurora, CO)
- …functional analysis/synthesis, interface definition and control, and/or verification and validation Qualifications We Prefer Knowledge of systems engineering ... create a safer, more secure world. We have an exciting opportunity for a Sr Systems Engineer supporting one of our premier programs in the business unit, where your… more
- Novo Nordisk Inc. (West Lebanon, IN)
- …for architecting and coordinating the design, installation, commissioning, startup and validation of all assigned new capital improvement projects. Primary the ... system administrator and quality system interface for...of projects from design through construction, commissioning, start-up and validation , ensuring that projects run on schedule, are cost… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …application of guidelines detailed in FDA 21 CFR Part 11, including system validation requirementsAdvanced understanding of database structure (Argus Safety ... and vendors. This position is also responsible for the delivery of systems , configuration and associated validation activities of Daiichi Sankyo… more
- Novo Nordisk Inc. (West Lebanon, IN)
- …floor to support product supply, deviations, corrective actions and related issues System owner for manufacturing systems (ie facilities, utilities, systems ... of best practices Coordinate fabrication, procurement, installation, engineering start-up, and validation activities of new equipment and systems Lead the… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …areas to provide informatics project management, SDLC Quality Model, subject matter, and computer system validation guidance to Global and Regional IT system ... meet business needs using a standard methodology. Oversee applications support groups' system validation and change control process. Collaborate with the… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …support to ensure effective operation, availability, and reliability of applications and/or systems to meet customer needs. Responsible for System Management ... Product Management/Ownership and Project Execution responsibilities for products and systems within the Digital, Patient Solutions, Marketing Technology, and other… more
- Merck & Co. (Rahway, NJ)
- …of product design and development; manufacturing process development, qualification, and validation ; and design control and risk management techniques to positively ... development programs ranging from concept generation/selection, development, verification, and validation to launch readiness:Lead the cross-functional Device Working Groups… more
- Merck & Co. (Durham, NC)
- …start-up testing in new laboratories using principles of our Production Systems , Lean Laboratories, and GMP requirements.- GENERAL PROFILE: Work cross-functionally ... to identify, to ensure successful execution of method transfer or method validation activities.Apply project management concepts and techniques as they relate to… more
- Merck & Co. (Lower Gwynedd, PA)
- …operational objectives for the Regulated Robotics teamDrives the computer system validation efforts for all departmental automation systems and LIMS. -- ... scientific and technical expertise in regulated assay design, automation, development, LIMS systems , system validation , and execution of these in support of… more
- Twist BioScience (South San Francisco, CA)
- …in a controlled environment (ISO, CLIA, eg) including integration testing, system validation , integration testing, and testing documentationStrong communication ... Twist Bioscience uses high throughput systems , powerful software, and unparalleled product throughput to enable rapid delivery of transformative products for our… more
- Exela Pharma Sciences, LLC (Lenoir, NC)
- …and modify procedures as needed to support clean-black utilities and HVAC systems .Participate in clean utilities validation activities during project life ... priorities, forecasting, and identifying resources needed to make improvement to existing systems as needed. This role is the site Subject Matter Expert (SME)… more
- Merck & Co. (Durham, NC)
- …chromatography columns)-Support Equipment (eg washers, autoclaves, tube welders/sealers)- Automated Systems (eg Distributed Control System (DCS), Programmable ... unitsAssisting in the identification, development, and implementation of new systems which enhances the operation and/or engineering processesAdapts and implements… more
- Twist BioScience (South San Francisco, CA)
- …of production processes, project management, Supply Chain andWarehouse Management, Validation , and Quality Systems . Prior experience supporting other ... Operations toensure a high quality of data throughout all systems where master data is used. Creates,reviews, and updates...data quality. Identify and maintain data ownership at the system , business function, or process levelas well at an… more
- Merck & Co. (Durham, NC)
- …The Manager will be responsible for using principles of our Company Production Systems , Lean Laboratories, and cGMP requirements in the laboratory.- The Manager will ... relate to analytical testing, regulatory requirements for new assay development/ validation , project timelines and budgetingProvides technical guidance to employees… more
- Merck & Co. (North Wales, PA)
- …including 21-CFR-Part-11, Annex 11, Good Laboratory and Clinical practices, Computer Systems Validation , and other global regulatory requirements that impact ... the development and implementation of pharmacovigilance strategies, processes, and systems for a pharmaceutical company, ensuring compliance with regulatory… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …OverviewThis position will be responsible for providing Commissioning, Qualification and Validation support to the cGMP Clinical and Commercial Cell Therapy ... management, issues, deviations, corrections and remediation efforts for facility, equipment, systems and processes in support of personalized cell therapy production… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …Closely collaborates with Digital on digital transformation projects and technology validation . Closely collaborates with Global System teams on platform ... closely with subject matter experts, SOP and process and system owners within NNI and Novo Nordisk A/S respectively...to pay platform and attains mastery in knowledge of systems . Identifies and drives continuous improvement in process. Utilizes… more
- Merck & Co. (Rahway, NJ)
- …and support from early stage through launch and supply, including mechanical systems design and manufacture, medical device design controls and device risk ... management, human factors evaluations, and design verification/ validation .Significant experience in analytical method development and validation , including… more
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