- 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
- Omni Inclusive (Summit, NJ)
- …and the global EMES team to create, manage, and improve computerized systems /Recipes validation deliverables for electronic systems , applications, and ... Systems *Familiar with the development of CSV documentation ( Validation Plans, Requirements, Design / Configuration Specifications, Test Scripts [IQ/OQ/PQ/UAT],… more
- Karma Automotive, Inc. (Irvine, CA)
- Description Engineer - EE Systems Integration & Validation The Engineer - EE Systems Integration & Validation will be responsible for integration, ... troubleshooting, analyzing, testing electrical components, systems , vehicle electrical systems and maintaining test and diagnostics software. Responsibilities… 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
- 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
- Merck & Co. (Rahway, NJ)
- …post-market commercial manufacturing support. BDSC supports stage 1 & 2 process validation deliverables (2011 FDA process validation guidance) including various ... to internal and external manufacturing sites, manufacturing investigations, process validation , second generation process development and authoring of regulatory… 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
- 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
- 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
- The Fountain Group (Cambridge, MA)
- …hours. MUST HAVE Argus Safety application and drug safety domain knowledge, Computer Systems Validation & SDLC experience, and strong matrix management skills. ... are a national staffing firm and are currently seeking ssoc. Director, PV Systems Reporting & Analytics for a prominent Pharmaceutical client of ours. This position… more
- Zoox (San Mateo, CA)
- …Zoox autonomous systems . You are responsible for the verification and validation strategy, test execution and reporting, and ensuring the robotaxi meets the ... Mechanical, Electrical, or Systems Engineering. 7+ years of hands-on systems integration and validation , (bench testing, simulation testing, structured… more
- Merck & Co. (Durham, NC)
- …technology transfer focusing on either upstream, downstream, and/or culture media/support systems . Off-shift and weekend coverage will be required based on business ... qualification studies associated with the development and implementation of processes, systems and facilities related to vaccine drug substance and key intermediates… 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
