- Legend Biotech USA, Inc. (Raritan, NJ)
- …technical studies, and any associated documentation in support of computer systems validation , equipment, utilities, and facility qualification, process ... data integrity.Key Responsibilities Provide quality and compliance oversight for computer systems validation , process validation , equipment, utilities, and… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Implementation Services Lead plays a key role in overseeing the development, validation , implementation, and integration of GxP-regulated systems across the ... organization. This position ensures that all global systems , electronic records, validation processes, and regulated applications meet strict regulatory… more
- Eisai, Inc (Nutley, NJ)
- …with Clinical Data Management processes, FDA regulations, SDLC methodologies, systems validation .Strong organizational skills with ability to effectively ... and CDISC standards. The role will require excellent technical skills in SAS systems and application development and experience. The Associate Director must be a… more
- BioAgilytix (San Diego, CA)
- …infrastructure.Essential ResponsibilitiesParticipates in implementation planning, qualification and/or validation of laboratory systems and softwareAuthors ... The Laboratory Systems Analyst is responsible for providing support to...systems validationMinimum Preferred Qualifications: SkillsProficiency in Computer System Validation , following GxP regulations and GAMP guidelinesAdvanced knowledge of… more
- Eisai, Inc (Nutley, NJ)
- …area Strong analytical skills and report writing skills Experience with GxP systems including computer system validation and associated regulations, recommended. ... Ability to Travel (approximately 15%)This role is hybrid and requires at least 2 days per week working onsite in our Nutley, NJ office. Eisai Salary Transparency Language:The base salary range for the Director, Clinical Quality Assurance is from… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionTitle: Specialist, Metrology and Validation , Analytical Research & DevelopmentJob Description-The Analytical Research & Development (AR&D) External ... Capabilities, Validation , and Compliance (ECVC) department of our company's Research Laboratories Division is seeking applicants for a Metrology and Validation … 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
- 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 ... Affairs teams to define MES requirements, design seamless integrations with other enterprise systems (eg, ERP, LIMS, QMS), and ensure compliant data flow across the… more
- Merck & Co. (Rahway, NJ)
- … Validation plans around equipment, critical utilities, and computer systems .- Prepare and approve qualification protocols and summary reports.- Execute ... qualifications, validation , commissioning, and decommissioning activities.- Prepare Validation ... plans and annual reports around critical equipment and systems .- Maintain GMP documentation where applicable, such as GMP… more
- BioAgilytix (Durham, NC)
- …processes to automate data extraction, transformation, and loading from core systems (LabVantage LIMS, ERP) into a centralized data repository.Design and implement ... for centralized data storage.Create APIs to enable real-time data sharing between systems , with a focus on operational efficiency and data integrity. Data Quality… more
- Repligen (Rancho Dominguez, CA)
- …device manufacturing, with deep expertise in Tangential Flow Filtration (TFF) systems , process engineering, and equipment qualification, preferably within GMP or ISO ... Act as a Subject Matter Expert for TFF and other bioprocessing manufacturing systems . Lead projects in equipment design, tech transfer, process validation , and… more
- Eisai, Inc (Exton, PA)
- …suites.The Associate Director writes, reviews, and/or approves GMP documents, including validation protocols and reports, and SOPs, along with providing supporting ... for ensuring routine suite and equipment maintenance, calibration, and validation with appropriate internal departments are done correctly and effectively3.… more
- Insmed Incorporated (San Diego, CA)
- …process development support testing function within analytical development. Will develop systems and processes to facilitate rapid, high throughput testing. As the ... and formulation development processes. Will support method transfer and validation as needed. Support the biotechnology product lifecycle, from early-stage… more
- Merck & Co. (Rahway, NJ)
- …Conduct laboratory-scale and manufacturing-scale studies to support commercial process validation and characterization. You'll design experiments, analyze data, and ... in the purification of biological molecules, including chromatography and filtration systems .Technology Transfer Experience: Proven track record in tech transfer or… more
- Merck & Co. (Durham, NC)
- …perform routine maintenance tasks, work with and troubleshoot complex process systems , including but not limited to:Utility Equipment (eg boilers, chillers, Cooling ... towers air compressors, waste deactivation systems )Clean Utility Equipment (eg HVAC, Clean steam generators, Water-For-Injection generation/distribution, reverse… more
- Novo Nordisk Inc. (West Lebanon, IN)
- …with coordinating fabrication, procurement, installation, engineering start-up, verification and validation activities of new equipment and systems . ... as needed as well as the continued operation of such facilities Ensures systems and processes are verified and validated in a compliant manner in accordance… more
- Formation Bio (New York, NY)
- …therapeutics while ensuring these capabilities evolve into robust, production-ready systems .Responsibilities Lead the Platform Science arm of Data Science, building ... product teams to transition proof-of-concept models into scalable, production-ready systems Define technical execution strategy for clinical outcome prediction,… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …initiatives requiring MES enhancements.Coordinate MES updates with other Supply Chain Systems (ERP, eLIMs, etc.).Coordinate and execute MES validation activities ... will be part of Manufacturing Excellence team reporting to the Manufacturing Execution Systems Lead and will be responsible for EBR development and administration at… more
- Merck & Co. (Durham, NC)
- …and assisting process project engineers.Assists with execution of automation, validation and additional testing, as requiredFollows instructions for completion of ... ability to follow complex instructions and use our Manufacturing Division business systems (SAP, ADP eTime, etc.)Physical requirements - Must be able to lift… 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 ... Training, QC, EM, Operations Technical Support, Facilities and Engineering, Validation .Requirements B.Sc./M.Sc. in Biological/Biochemical Science/Bioengineering related field. Trade /… more
Related Job Searches:
Computer Systems Validation,
Computer Systems Validation Engineer,
Computer Systems Validation Specialist,
Senior Computer Systems Validation,
Software Systems Validation Engineer,
Systems,
Systems Engineer Verification Validation,
Systems Validation Engineer,
Systems Validation Manager,
Validation