- Twist BioScience (South San Francisco, CA)
- …Eudralex Annex 11, with practical experience applying them to custom software development and validation .Strong understanding of biotechnological and ... etc.) and associated automation/control systems (SCADA, DCS, PLC, HMI) from a software integration perspective.Expertise in computer system validation (CSV) and… 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... activities associated with new or upgraded instrumentation or software packages to ensure 21 CFR part 11 ComplianceSupport… more
- Insmed Incorporated (San Diego, CA)
- …and formulation development processes. Will support method transfer and validation as needed. Support the biotechnology product lifecycle, from early-stage ... candidates and troubleshooting technical issues. Contributes to method qualification and validation according to regulatory guidelines such as ICH, FDA, and cGMP,… more
- BioAgilytix (Durham, NC)
- …for someone with a strong background in method development, GxP-compliant validation , and targeted and untargeted analysis using chromatography and mass ... project deliverables with client timelines and expectations.Lead assay development, validation , and sample analysis of biologics, proteins, peptides, ADCs, and/or… more
- BioAgilytix (San Diego, CA)
- …and metabolite profiling/ID. You'll guide a team of scientists through assay development, validation , and sample analysis under GxP, while also playing a key role in ... managing departmental budgets and resources, and being the expert in using tools/ software relevant to the team.Work closely with clients to assure successful on… more
- Pharmavise (Lebanon, PA)
- …documentation Document upload and control of deliverables within Kneat (the client's validation software solution system) Uploading and management of C&Q related ... 500 Pharmaceutical client has an exciting opportunity for a Validation Engineer (Automation). Job Summary: We are seeking a...technical writing skills A high proficiency in using Microsoft software such as Word and Excel. Experience of working… more
- Merck & Co. (Rahway, NJ)
- …of using statistics in data analysis and familiar with using statistical software for design of experiments.Experience with qualification, validation , and ... Chromatography (LC), Management Process, Matrix Management, Mentoring Staff, Method Validation {+ 5 more}-Preferred Skills:Job Posting End Date:08/23/2025 *A job… 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 ... decisions standpoint.Experience in equipment Fabrication, FAT/SAT, start-up, qualification and/or validation is preferredFill/finish process scale-up, Drug Delivery and/or technology… more
- Omni Inclusive (Summit, NJ)
- …with the ALCOA+ principles of data integrity, risk-based approaches to validation , Computer Software Assurance (CSA) principles *Understanding the concept ... onsite when manager requests) The Specialist works cross-functionally to execute validation activities and prepare validation deliverables for S12 Enterprise… more
- Eisai, Inc (Nutley, NJ)
- …of Eisai Clinical Computing Environment Support study migration, program validation , technical documentationManage J-Review set up, J-Review user access management, ... and experience are required.Experience with programming methodologies, best practices, software applications development/support in the pharmaceutical or related industries,… 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 applicable Perform exploratory analysis, ad hoc analyses, and modelling of data Review and approve randomization… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …with other Supply Chain Systems (ERP, eLIMs, etc.).Coordinate and execute MES validation activities according to the Software Development Lifecycle (eg ... with other functions including but not limited to Tech Support, Process Improvement, Validation , Supply Chain, Operations, QA, Reg CMC, and IT. This individual will… more
- Merck & Co. (North Wales, PA)
- …lifecycle. Primary Activities :Effective analysis and report programming development and validation utilizing global and TA standards and following departmental SOPs ... Experience: Strong working knowledge of reporting processes (SOPs) and software development life cycle (SDLC)Experience providing technical and/or programming… more
- Merck & Co. (North Wales, PA)
- …have a solid knowledge of statistical methodology, experimental design, computing software and data management; a general understanding of worldwide regulatory ... all programs meet analysis requirements, internal standard operating procedures, validation , and external regulatory requirements.6. Evaluates appropriateness of available… more
- Merck & Co. (Rahway, NJ)
- …required.Proficient in computer-aided design (CAD) and computer-aided engineering (CAE) software such as SolidWorks, AutoCAD etc.Experience in machining, prototyping ... Design, Mechanical Testing, Medical Device Manufacturing, Medical Devices, Method Validation , Operational Acceptance Testing (OAT), Product Development, Prototyping, Social… more
- Katalyst HealthCares and Life Sciences (Lake Bluff, IL)
- …Science or related technical field. Minimum of 4-5 years of experience in software quality assurance or software validation , preferably within the ... FDA 21 CFR Part 820, ISO 13485, IEC 62304.) Experience with non-product software validation , including tools for development, testing, and maintenance. Good… more
- Merck & Co. (San Francisco, CA)
- …including process or analytical development, characterization, technology transfer, validation /PPQ, commercial manufacturing, and process and plant modeling.General ... data lakes, dashboards, data models, etc.).Proficiency in portfolio management software such as Planisware, MS Planner/Dynamics 365, etc. Understanding of… more
- Merck & Co. (North Wales, PA)
- …- Primary Activities : Effective analysis and report programming development and validation utilizing global and TA standards and following departmental SOPs and ... process compliance. Strong working knowledge of reporting processes (SOPs) and software development life-cycle (SDLC) US and/or worldwide drug or vaccine regulatory… more
- Qcells (Irvine, CA)
- …embedded firmware, cloud-connected platforms, and mobile apps (iOS, Android). Deploy software QA metrics, regression testing, automation, CI/CD validation gates, ... Develop and implement rigorous quality planning, supplier audits, and integrated software + hardware validation plans. Cross-Functional Quality Collaboration -… more
- Microsoft (Mountain View, CA)
- …requirements, environments, tools, and methodologies including debug board and hardware/ software requirements Apply your knowledge of validation principles ... functions in an extremely efficient manner. We are looking for a Principal Validation Engineer to join our team! Microsoft's mission is to empower every person… more