- Novo Nordisk Inc. (West Lebanon, IN)
- …to realize your potential? The Position This position will lead a team of Validation Engineers and Validation Technicians, and is responsible for the design, ... and direction for cell culture, fermentation, purification, engineering, design, validation , and scale-up. Prior supervisory/leadership experience is preferred, including… more
- Exela Pharma Sciences, LLC (Lenoir, NC)
- Position Summary:Oversee and lead the validation program for production equipment and processes used to support manufacturing of aseptic and terminally sterilized ... products. Lead the validation team in the establishment and maintenance of validated...capability. Support manufacturing to satisfy the quality and process validation requirements for existing products. Participate in the development… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …immunotherapy in the treatment of multiple myeloma.Legend Biotech is seeking a Cleaning Validation Lead as part of the Technical Operations team based in Raritan, ... NJ. Role OverviewThe Cleaning Validation Lead will be responsible for creating and maintaining...will be responsible for creating and maintaining the cleaning validation program for the Cell Therapy facility following necessary… more
- Aequor (Libertyville, IL)
- …new business systems and practices, primarily GxP.Understanding of computer system validation and experience using IT service management platforms (QMS) to support ... managing IT deviations, CAPAs, Investigations, Change Management, and computer system validation in support of the vector manufacturing site.The candidate should… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Reporting provides leadership in Data Management Operations for the Data Validation and Reporting function by collaborating with internal and external stakeholders ... clinical data programming, reporting, data visualizations, external data acquisition and validation , and tools to support project portfolio across drug programs.… more
- Merck & Co. (Lower Gwynedd, PA)
- …limited supervision to all aspects of assay development, qualification/ validation , technology transfer, and/or troubleshooting.- Preferably, the successful candidate ... track record for developing assays capable to meet Regulatory expectations for validation and line of sight for life-cycle maintenance.-Job Location: SHIP, PA Main… more
- Merck & Co. (Rahway, NJ)
- …to internal and external manufacturing sites, manufacturing investigation, process validation , and authoring of regulatory submissions. -Under the general scientific ... late-stage clinical process development, characterization, and technology transfer and validation with line-of-sight for licensure and commercialization.-Drives division wide… more
- Merck & Co. (Durham, NC)
- …the coordination of resources and equipment pertaining to qualification/ validation activities supporting the vaccine expansion facility.Primary Responsibilities:The ... that ensure required safety guidelines are followed.Review and approve qualification/ validation documents for equipment and process (ie, IQ/OQ/PQ).Review and approve… more
- Merck & Co. (Rahway, NJ)
- …therapeutics. The successful candidate will also collaborate with external laboratories for validation , data generation and quality control, and serve as a technical ... disease and/or oncology. Key Responsibilities Lead the design, development, and analytical validation of internal next generation sequencing RNA and DNA based assays… more
- Merck & Co. (Rahway, NJ)
- …team. The individual will play a critical role in the development and validation immunoassay-based assays that are deployed in support of clinical trials. The ... The candidate should have a strong interest in lab-based assay development, validation , and clinical sample analysis. In addition, the candidate should have interest… 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. (Rahway, NJ)
- …to internal and external manufacturing sites, manufacturing investigation, process validation , and authoring of regulatory submissions. -Under the general scientific ... stage clinical process development, characterization, and technology transfer and validation with line-of-sight for licensure and commercialization.-Responsible for laboratory-scale… more
- Merck & Co. (Rahway, NJ)
- …technology transfer to internal and external manufacturing sites, process validation , manufacturing investigations and trend analysis, process enhancements, next ... late-stage clinical process development, characterization, and/or technology transfer and validation with line-of-sight for licensure and commercialization.Responsible for laboratory-scale… more
- Merck & Co. (Rahway, NJ)
- …our team. The individual will play a critical role in the development and validation of Mass Spectrometry based assays that are deployed in support of clinical ... The candidate should have a strong interest in lab-based assay development, validation , and sample analysis. In addition, the candidate should have interest to… more
- Exela Pharma Sciences, LLC (Lenoir, NC)
- …Pass Yield, Scrap, number of repeat CAPAs, CAPA On Time, and Validation on Time.Job ResponsibilitiesChange Management - evaluate the impact to product, processes, ... changes on critical attributes and quality architectures.Commissioning, Qualification and Validation - provide Quality support and oversight for commissioning,… more
- Lundbeck (Bothell, WA)
- …a growing biologics pipeline in collaboration with our Copenhagen-based Process Science & Validation Team. The Lu-SBP team leads and supports the development of new ... product candidates from cell line development through commercial validation of Drug Substance and Drug Product manufacturing processes. Join us on our journey to… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …improving. Work with the Data Management and Integration Lead and Process Validation lead on the establishment and management of a process monitoring program. ... cell therapy processes, manage equipment qualification strategy, and support process validation activities for cell therapy platforms. RequirementsA minimum of a… more
- Aequor (NV)
- …of pharma/biotech experience *Biotech/ pharma experience required) * Analytical method validation and transfer experience Ideal candidate with a bachelor's degree in ... of the global method implementation team responsible for method transfer and method validation to Quality Control for pivotal and late stage programs. The role will… more
- Aequor (Swiftwater, MN)
- …Pack Assembly Data pack assembly is critical position in the execution of validation and development studies. The position will support the Validation ... Coordination The sample coordinator is a critical role in the execution of validation and development studies. Failure to comply with the protocol could create… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …team and will oversee the reviewing and approving of site SOPs, method validation / qualification/ transfers, and general compliance / quality oversight for the ... audits by ensuring inspection readiness at all timesReview and approve Method validation / qualification / transfer protocols and reportsSupport day to day… more
Related Job Searches:
Model Validation,
Process Validation Engineer,
Quality Validation Engineer,
Senior Validation Engineer,
Sr Validation Engineer,
Validation Engineer,
Validation Engineer II,
Validation Manager,
Validation Specialist,
Validation Test Engineer