- Merck & Co. (Rahway, NJ)
- …transfer to internal and external manufacturing sites, manufacturing investigations, process validation , and authoring of regulatory submissions. -Under ... investigations and trend evaluations, process enhancements, next generation process development and characterization, process validation , and… 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 system ... organized, and innovative leader to lead our Laboratory Operations and System Validation team. The successful candidate will coach and mentor staff, oversee the… more
- Merck & Co. (Durham, NC)
- …areas including Biological, Chemical, Automation, Capital Projects, Maintenance, Safety, Process Development, Technical Services, Utilities and Validation .- ... assessments Author or approve Change Control documentation for complex process , validation , analytical, equipment, facility/utility and/or automation changes.… more
- Merck & Co. (Rahway, NJ)
- …areas including Biological, Chemical, Automation, Capital Projects, Maintenance, Safety, Process Development, Technical Services, Utilities and Validation . We ... also involves collaboration (largely remotely) with external suppliers while managing process development and validation activities. Travel is expected ranging… 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 ... deep knowledge in device design, requirement management, design verification, automation/ process development, design validation , and control strategy.Knowledge… more
- Merck & Co. (Rahway, NJ)
- …to develop safe, robust and productive processes, through scale-up, tech transfer, process characterization, validation and filing.- This role involves hands-on ... analysisExperience with chemical engineering-related technology developmentExperience with risk assessments, process characterization, validation , and regulatory authoring.Proven track… more
- Merck & Co. (North Wales, PA)
- …technology transfer to internal and external manufacturing sites, manufacturing investigations, process validation , and authoring of regulatory submissions. - - ... Cell Culture and Fermentation Sciences (CCFS) department provides the technical process leadership and laboratory capabilities in support of late-stage pipeline and… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …of the CMO activities: deviation investigation, change control and risk assessment, process improvement, continuous process validation .Support commercial and ... manufacture performance. Identify, investigate and act upon out-of-trend critical process parameters (CPP) in- process testing and CQAs.Work with… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …opportunities to improve process and operation.Work with CMO on continuous process validation (CPV).Provide timely and accurate update on the CMO performance ... the technical side of the CMO operation.Key Responsibilities Collect, analyze critical process parameters (CPP) data, in- process testing data, and drug product… more
- Merck & Co. (Durham, NC)
- …and technical guidance to employees, colleagues, or clients.Review and approve qualification/ validation documents for equipment and process (ie, IQ/OQ/PQ).Review ... pharmaceutical manufacturing industry, specifically in pharmaceutical operations, technical operations, validation and/or process Quality Assurance.Required Experience and… more
- 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),… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …organizing primary and secondary research, for example in the targeting and validation process Adheres to administrative policies and procedures and encourages ... action without direct line management responsibility We commit to an inclusive recruitment process and equality of opportunity for all our job applicants. At Novo… more
- Novo Nordisk Inc. (West Lebanon, IN)
- …representative for contractor services including design, fabrication, installation and validation Point person for process improvement activities Responsible ... This individual provides expertise in cell culture and purification process equipment and supporting utilities for biotechnology manufacturing. This individual… more
- Novo Nordisk Inc. (West Lebanon, IN)
- …user representative for contractor services including design, fabrication, installation and validation Point person for process improvement activities, including ... of subordinates with direct/indirect referral: None Essential Functions Leads process and equipment troubleshooting to support deviations, corrective actions and… more
- Novo Nordisk Inc. (West Lebanon, IN)
- … improvements/cost reduction program into manufacturing Perform area equipment and process validations in accordance with validation procedures Perform in- ... of routine documentation associated with the manufacture of product Support in- process activities and product development when instructed by supervisor Incorporate… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …business needs using a standard methodology. Oversee applications support groups' system validation and change control process . Collaborate with the Services ... informatics project management, SDLC Quality Model, subject matter, and computer system validation guidance to Global and Regional IT system owners so they can… more
- Merck & Co. (Durham, NC)
- …Specialist, Quality Control participates in a team of analysts in the development, validation , and routine testing of the BCG Product. Initially the position will ... production.- The selected candidate will initially work on assay development, assay validation , equipment validation , and GMP laboratory readiness.- The Senior… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionOur Company's Device Product and Process Development (DPPD) Team is seeking a hands-on device characterization and design focused scientist.This ... including engineering studies, design verification protocols, stability studies and validation protocols, ensuring appropriate selection of acceptance criteria and… more
- Merck & Co. (Durham, NC)
- …to identify, to ensure successful execution of method transfer or method validation activities.Apply project management concepts and techniques as they relate to ... laboratory testing start-up, regulatory requirements for method transfer/ validation project timelines and budgetingBuild knowledge of the company, processes and… more
- Merck & Co. (South San Francisco, CA)
- …development and optimization to support drug development, target identification and validation activities in close partnership with colleagues in the group, ... innovative molecular and cell biology platforms to advance target validation and drug discovery effortsCollaborate with multiple stakeholders directly contributing… more
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