- Daiichi Sankyo, Inc. (Bernards, NJ)
- …procedures. Provide expertise and solutions to CSV questions and issues.Responsibilities- Provide Validation Lead support for Daiichi Sankyo GxP and Non-GxP ... Validation Plans, Protocols (IQ/OQ/PQ), Test Scripts and Summary Reports. Support the change management process for validated systems where necessary.Maintain… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …Validation program through the life cycle of the program.Key Responsibilities Support validation engineers/scientists in drafting protocols and reports for ... validation studies in order to determine acceptability, reproducibility, and control. Support validation engineers/scientists in aseptic process validation… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …the global MSAT organization. This individual will be responsible for global process validation activities in support of the commercial Carvykti program both ... closely with senior Janssen leadership to achieve global alignment on all validation Carvykti scopeProvide organizational leadership and support of an expanding… more
- Aequor (Bothell, WA)
- …of system validation periodic reviews and audit activities as well as support of computer system validation efforts for new system implementations and ... Job Description: Job title: Computer System Validation EngineerLocation: Bothell, WA* HybridTop Skills: Strong knowledge on MES systems (ie Emerson Syncade) and ERP… more
- Merck & Co. (Rahway, NJ)
- …transfer activities (RY or WP as needed).Apply project management tools to support validation and transfer activities for pipeline commercialization and inline ... transfer protocols and reports; assist labs with sample/consumable logistics in support of validation and transferCommunicate effectively across functions and… more
- Exela Pharma Sciences, LLC (Lenoir, NC)
- …changes on critical attributes and quality architectures. Commissioning, Qualification and Validation - provide Quality support and oversight for commissioning, ... essential skill for this position. Strong competency in C&Q/CSV/GAMP and Validation practices. Greenbelt CertificationMinimum 4-5 years' experience working in GMP… more
- Careerbuilder-US (Kirkland, WA)
- …min 6 months contract ( Go longer as per business need) About the Role The Validation Support Technician 3 will be responsible for providing support to ... equivalent experience in a related discipline 2+ years of troubleshooting, tech support , test execution, IT experience, or relevant experience (5+ years is… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …for working with groups to provide start-up, commissioning, and qualification/ validation support of instrumentation and systems including on-the-floor ... NJ.Role OverviewThis position will be responsible for maintenance and metrology support and mechanical system operations for cGMP Clinical and Commercial Cell… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …at least 5 years' experience in fit-for-purpose clinical biomarker assay development, validation , and implementation in support of multi-site clinical trials. ... biology, broad technical expertise, and direct experience in biomarker assay development/ validation and oversight at external CROs and specialty labs and involves… more
- Aequor (Thousand Oaks, CA)
- …knowledge and experience to research, development, clinical studies, product validation in support of regulatory submissions.Basic Qualifications: Master's ... engineering, design, commercial, quality, and regulatory teams. This person will support human factors research driving innovative, intuitive, and useful products.… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …implementation teams (including external vendors) in the design, development, implementation, validation , roll-out, training and support of global and regional ... systems to meet business needs using a standard methodology. Oversee applications support groups' system validation and change control process. Develop… more
- Merck & Co. (Durham, NC)
- …Direct support of regulatory inspections and audits, as requested Direct support of validation activities and all other associated Quality functions Other ... with Production, Technology, and Quality Assurance as required to support vaccine manufacturing.Primary Responsibilities General Profile Ability to work… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …processing while liaising with other functions including but not limited to Tech Support , Process Improvement, Validation , Supply Chain, Operations, QA, Reg CMC, ... electronic batch record (EBR) updates and system improvements and integrations, support applicable process and facility updates, and support qualification… more
- The Bartech Group Inc (Pontiac, MI)
- …are involved, and effective cross-organizational teamwork is crucial.Follow development and validation hardware through readiness process - support setup and ... recruitment solutions. Our client has engaged us to assist them in hiring a contract Validation Engineer. If you are interested in an opportunity to get your foot in… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …setting with quality counterparts that include Manufacturing Operations, Engineering and Validation , Quality Control, Operations Technical Support , Supply Chain ... the document management process within a cell therapy manufacturing facility to support both clinical and commercial requirements in a sterile GMP environment. This… more
- Merck & Co. (Rahway, NJ)
- …join 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 ... 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
- Merck & Co. (Lower Gwynedd, PA)
- …be responsible to lead vaccine bioanalytical assay development, qualification/ validation , technology transfer, and/or troubleshooting to meet regulatory expectations ... for validation and line of sight for life-cycle maintenance. Importantly,...format selection based on risk assessment and fit-for-purpose considerations. Support of pre-clinical/clinical sample analysis as needed. Understand, leverage,… more
- MAHLE, Inc (Lockport, NY)
- …inside of the same product line -Define common strategy for second sources validation -Technical support to project buyers, SQEs and logistics -Technical ... engineering domains (Requirements Management, Hardware, Software, Mechanics, Functional Safety, Validation and Industrialization) to accomplish prototypes and the project… more
- American Honda Motor Co Inc (Greensboro, NC)
- …coordinate, facilitate meetings and provide communication within the company in support of Conformity and Validation projectso Review certification documentation ... General Summary:With minimal supervision, the Validation Team member is responsible for facilitating and coordinating activities to support FAA conformity,… more
- Aequor (San Diego, CA)
- …is a plus *RESPONSIBILITIES* Utilize and develop multiple disease models to design target validation studies and relevant assays in support of SAR, mechanism of ... action, mechanisms of resistance, biomarker selection, and disease positioning. Develop and implement cell-based assays to address both tumor intrinsic cellular biology and immune-based mechanisms of action for potential drug candidates Design and conduct… more
