- 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
- Tris Pharma (Monmouth Junction, NJ)
- …Monmouth Junction, New Jersey, Tris has an immediate opening for a Method Validation R&D Senior Scientist ISummary:The Method Validation (MV) Research and ... with company policies, SOPs, and state, federal and local laws Performs validation of analytical methods and release/stability testing for raw materials, IP, FP… 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
- 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
- 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 (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
- 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
- Lundbeck (Bothell, WA)
- …a growing biologics pipeline in collaboration with our Copenhagen-based Process Science & Validation Team. The Lu-SBP team leads and supports the development of new ... product candidates from cell line development through commercial validation of Drug Substance and Drug Product manufacturing processes. Join us on our journey to… 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
- 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. (Austin, TX)
- …PowerShell, and REST APIs.Participate in test planning, safety validation , change control, and rollback design.Document technical implementations, integration ... Material(s):Required Skills:Design Applications, Information Security, Security Operations, SLA Management, Software Development, Software Development Life Cycle (SDLC),… 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. (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
- Merck & Co. (Durham, NC)
- …tools and calibration equipment)-Assist with execution of calibration, automation, validation and additional testing, as requiredDecisions are guided by policies, ... 3rd - NightValid Driving License:NoHazardous Material(s):n/aRequired Skills:Automation, Calibration Management Software , Calibration of Equipment, Equipment Maintenance, Equipment Troubleshooting, Good… 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. (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
- 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
- Adecco US, Inc. (Buffalo, NY)
- ** Software Validation Engineer** **Buffalo, NY** **Hybrid Position** **$80k-$85k and Benefits Include** - Health, Dental, and Vision insurance, 401K, Paid ... departments. * Responsible for updating and implementing improvements to the software validation system and procedures. + Complies and writes training material… more
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