- 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
- Woven by Toyota (Palo Alto, CA)
- …by Toyota. We build the frontend and backend frameworks that power ADAS software validation workflows using data from real-world driving, simulation, and ground ... AD/ADAS, our autonomous driving and advanced driver assist technologies; Arene, our software development platform for software -defined vehicles; Woven City, a… more
- Johnson and Johnson (Danvers, MA)
- …Preferred Qualifications: Six Sigma or Lean certification. Experience with equipment and software validation (21 CFR Part 11 compliance). Familiarity with ... the Role: We are seeking a highly experienced and driven Principal Validation Engineer to lead process validation initiatives for complex electro-mechanical… more
- Katalyst HealthCares and Life Sciences (Hartford, CT)
- … software -based systems. Requirements: 6 to 8 years of Non-Product Software Validation engineer with Manufacturing background (Medical devices or ... Diagnostics). Non-Product software validation for Manufacturing Equipements as per Regulatory standards (FDA, ISO requirements). Prepare, review functional… more
- Katalyst HealthCares and Life Sciences (West Mifflin, PA)
- … Validation . Must have Experience with writing procedures. Must have Experience with Software validation . Must have Pharma or Medical device experience. ... contractors to complete the 6-month project. The Senior Process Validation engineer will be in charge of procedure changes,...and validating some printers, while validating some of the software pieces to the printers. 7-12+ Years of experience… more
- Talascend (Auburn Hills, MI)
- …creation and tracking using tools such as Excel VBA, Python, or specialized validation software . Automate test maneuver, identify test patterns using tools such ... as Excel VBA, Python, or specialized validation software . Integrate test results and feedback into DVPs to support continuous improvement and issue resolution.… more
- Diverse Lynx (Erie, PA)
- …based energy storage or propulsion system of 1500+ volt systems.*Experience with Rail/Automotive software validation of safety Integrity levels (SIL) per rail or ... automotive standards. *Understanding the Requirement and design the validation plan, Validation report, traceability tool such as Doors.*Design and Develop test… more
- System One Holdings, LLC (Bellevue, WA)
- …the Natrium Demonstration reactor and is primarily responsible for the verification and validation of software and evaluation models used to perform: *Analysis ... design media. Key Qualifications and Skills *Extensive experience in nuclear safety software verification and validation activities and system transient analysis… more
- Hayden AI (San Francisco, CA)
- …BS in an engineering discipline or equivalent 10+ years of experience in software engineering, validation , or system testing roles Strong background in building ... future. What the job involves: We're looking for a hands-on Principal Quality & Validation Engineer to design and build the validation infrastructure for our… 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
- 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
- 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
- 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
- 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
