- Merck & Co. (Rahway, NJ)
- …and post-market commercial manufacturing support. BDSC supports stage 1 & 2 process validation deliverables (2011 FDA process validation guidance) including ... to internal and external manufacturing sites, manufacturing investigations, process validation , second generation process development and authoring of regulatory… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …of an immunotherapy in the treatment of multiple myeloma.Legend Biotech is seeking QA Validation Specialist III as part of the Quality team based in Raritan, NJ. ... Role OverviewThe QA Validation Specialist role is an exempt level position with...clinical quality, or cell therapy.Knowledge of cGMP regulations and FDA /EU guidance related to GMP manufacturing of biopharmaceuticals.Experience in… more
- Eisai, Inc (Nutley, NJ)
- …SQL, CDISC, and CDASH.Familiarity with Clinical Data Management processes, FDA regulations, SDLC methodologies, systems validation .Strong organizational skills ... of Eisai Clinical Computing Environment Support study migration, program validation , technical documentationManage J-Review set up, J-Review user access management,… more
- Merck & Co. (Rahway, NJ)
- …medical device engineering, particularly in the design, manufacturing, verification, validation and associated quality and regulatory aspects of combination ... of product design and development, manufacturing process development, qualification, validation , and design control and risk management techniques to positively… more
- Merck & Co. (Durham, NC)
- …Specialist, Quality Control participates in a team of analysts in the development, validation , and routine testing for the BCG Product. The position will focus on ... for commercial production.- The selected candidate will participate in equipment validation , process validation , and GMP laboratory readiness.- The Quality… more
- Twist BioScience (South San Francisco, CA)
- …requirements gathering, system design, coding standards, development, rigorous testing, validation , deployment, and post-go-live support for new and existing ... capabilities to support operational decision-making and quality reviews.Compliance & Validation : Ensure our custom MES solutions comply with GxP regulations… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …scale cGMP manufacturing, operations management, tech transfer, process and equipment validation or quality management; with a preference for Cell/Gene Therapy ... to prepare for tomorrowTrack record of successfully leading audits and inspections ( FDA , EMA, etc.)An ability to build strong partnerships and effectively integrate… more
- Insmed Incorporated (San Diego, CA)
- …and validation according to regulatory guidelines such as ICH, FDA , and cGMP, evaluating method characteristics like specificity, sensitivity, accuracy, and ... and formulation development processes. Will support method transfer and validation as needed. Support the biotechnology product lifecycle, from early-stage… more
- BioAgilytix (Durham, NC)
- …visibility into validated data.Maintain Audit-Ready Traceability: Ensure comprehensive data-lineage and validation documentation is always ready for FDA , EMA, or ... Microsoft Power Automate to automate high-frequency, repetitive tasks, such as data validation and QC compliance checks.Establish automated data validation and… more
- Merck & Co. (Rahway, NJ)
- …/ engineering work process and deliverables (eg equipment fabrication, FAT, SAT, Validation etc.)Must be innovative and drive new ideas, but also have pragmatic ... options, technology selection and regulatory postureDemonstrated working knowledge of FDA , ICH, and other regulatory requirements for CMC.- Strong experience… more
- Novo Nordisk Inc. (West Lebanon, IN)
- …coordinating fabrication, procurement, installation, engineering start-up, verification and validation activities of new equipment and systems. Responsibilities ... processes are verified and validated in a compliant manner in accordance with FDA , EU and NN requirements Actively participate on cross functional teams to determine… more
- Merck & Co. (Durham, NC)
- …Author or approve Change Control documentation for complex process, validation , analytical, equipment, facility/utility and/or automation changes. Managing on-time ... process change control Authored complex deviation investigations Experience with validation documentation and execution Experience with SAP Experience with… more
- Aequor (Hicksville, OH)
- …paperwork for upcoming batches. Sets up and monitors cleaning and filling Validation batches according to protocols. Accepts and controls labels for individual ... and all other quality or regulatory requirements (OSHA, DEA, FDA , EMEA, ANVISA, HS&E, etc.). Ensures all work is...and in compliance with the appropriate industry and regulatory ( FDA , DEA, OSHA) standards, and Departmental, Plant, and Corporate… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …with other functions including but not limited to Tech Support, Process Improvement, Validation , Supply Chain, Operations, QA, Reg CMC, and IT. This individual will ... other Supply Chain Systems (ERP, eLIMs, etc.).Coordinate and execute MES validation activities according to the Software Development Lifecycle (eg commissioning test… more
- Genmab (NJ)
- …according to applicable SOPsGive input to eCRF setup, edit checks, validation plan, protocol deviations classifications, DSUR, IB updates, tables, figures, and ... listings etc.Review assay validation reports, as applicablePerform exploratory analysis, ad hoc analyses, and modelling of dataReview and approve randomization and… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …training program for Operations (Manufacturing, Warehouse, Facilities & Engineering, Validation , Technical Support, Supply Chain) that supports daily clinical ... quality systems, or learning management systems.Knowledge of cGMP regulations and FDA /EU guidance related to manufacturing of cell based products as well… more
- Aequor (Cincinnati, OH)
- …Perform routine and non-routine physical and chemical testing of commercial, validation and stability samples in accordance to written methodology Analyze data ... COMPLIANCE AND QUALITY Basic knowledge and understanding of USP, cGMP, and FDA regulations Create and maintain lab record documentation (notebooks and computer… more
- Eisai, Inc (Nutley, NJ)
- …all applicable worldwide regulations and guidelines (eg US, EU Directives, US FDA , PMDA, ICH). Essential Functions Independently conduct audits Review and oversee ... writing skills Experience with GxP systems including computer system validation and associated regulations, recommended. Ability to Travel (approximately 15%)This… more
- Empower Pharmacy (Houston, TX)
- …the distinguished position of being the largest 503A compounding pharmacy and FDA -registered 503B outsourcing facility in the country serving the functional medicine ... Join us and be a part of something extraordinary. Position Summary The Validation Engineer III ensures regulatory compliance by overseeing the validation of… more
- Katalyst HealthCares and Life Sciences (Warren, NJ)
- Responsibilities: The Validation Engineer supports the successful implementation of laboratory equipment and systems at multi-use sites through interaction with ... projects of limited scope and complexity. Author and execute commissioning/qualification/ validation deliverables including assessments, plans, system requirements, protocols, traceability… more
