- Legend Biotech USA, Inc. (Raritan, NJ)
- …level position with responsibilities for providing quality oversight over the validation and qualification activities for equipment, systems, computer systems, ... assessments, technical studies, and any associated documentation in support of computer systems validation , equipment, utilities, and facility qualification,… more
- Merck & Co. (Rahway, NJ)
- …and instrumentation in both GMP and non-GMP environment Participate in laboratory computer system validation activities associated with new or upgraded ... Skills:Adaptability, Adaptability, Analytical Chemistry, Analytical Instrumentation, Change Management, Communication, Computer System Validation (CSV), Data Analysis, Diversity… more
- BioAgilytix (San Diego, CA)
- …specification, IQ/OQ/PQ, etc.) Contributes to the development and revision of Computer System Validation procedures and policies (validations, change control, ... with computer systems validationMinimum Preferred Qualifications: SkillsProficiency in Computer System Validation , following GxP regulations and GAMP… more
- Twist BioScience (South San Francisco, CA)
- …Eudralex Annex 11, and internal quality standards. Oversee and execute comprehensive computer system validation (CSV) activities, including IQ, OQ, PQ protocols ... (SCADA, DCS, PLC, HMI) from a software integration perspective.Expertise in computer system validation (CSV) and GxP documentation practices, particularly… more
- Quality Chemical Laboratories (Wilmington, NC)
- …candidates for qualified analytical data reviewers, LabWare LIMS development/configuration/ validation , Document Control Associates, Computer System ... degree in Chemistry or related science and experience in method development/ validation . Special consideration also given to experienced GMP data reviewers. QCL… more
- Eisai, Inc (Nutley, NJ)
- …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 :195,000-256,000Under… more
- Barry-Wehmiller Companies (Los Angeles, CA)
- …management tools and word processing skills. Working knowledge of process automation and computer system validation concepts, GAMP methodologies, 21 CFR Part 11 ... build a better world. Job Description: Client Development Lead, Validation and Regulatory Compliance (Design Group) Who You'll Work...you join Design Group as a Client Development Lead, Validation and Regulatory Compliance, you are joining a team… more
- Project Farma (Chicago, IL)
- …Transfers; Validation Life Cycle (including Commissioning and Qualification, Process Validation , Computer System Validation , etc.); GxP Automated ... with cross-functional client departments including, but not limited to, Validation , Manufacturing, Quality, Supply Chain, and Engineering. You will proactively… more
- Validation & Engineering Group Inc. (New Albany, OH)
- …and Medical Devices industries in the following areas: Laboratory, Compliance, Computer , Engineering, Project Management, Validation , and other services. We ... Validation & Engineering Group, Inc. (V&EG) is a...under the highest ethics standards for the following position: Validation Specialist for Packaging Equipment Qualifications: Bachelor's Degree in… 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
- System One Holdings, LLC (Bellevue, WA)
- …and/or Design Basis Accident (DBA) Without Radionuclide Release *Nuclear safety analysis computer code assessment, verification and validation The Senior Safety ... the guidance in NRC's RG1.203. *Perform and coordinate safety computer code verification and validation test programs,...and coordinate safety computer code verification and validation test programs, including SETs and IETs *Support and… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …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 requirements, industry best… more
- Merck & Co. (Rahway, NJ)
- …approve GMP procedures and documentation, with an emphasis on Qualification and Validation plans around equipment, critical utilities, and computer systems.- ... and approve qualification protocols and summary reports.- Execute qualifications, validation , commissioning, and decommissioning activities.- Prepare Validation … 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 (Durham, NC)
- …Microsoft Power Automate to automate high-frequency, repetitive tasks, such as data validation and QC compliance checks.Establish automated data validation and ... into validated data.Maintain Audit-Ready Traceability: Ensure comprehensive data-lineage and validation documentation is always ready for FDA, EMA, or sponsor… 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 ... with clients to assure successful on time execution of assays, validation , and sample analysis under GxPs.Prioritizing tasks and managing schedules efficiently.Meet… 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, ... terms of program development and propose/implement solutions. Requirements Bachelor's degree in computer science or related field required.Must have 10 or more years… more
- Hays Recruitment (San Francisco, CA)
- …Princeton, NJ. Role Description o About the Role We're seeking a Senior MES Engineer/ Validation Lead to take ownership of computer system validation ... environments are preferable Must Have List *4+ years of Computer System Validation (CSV) experience in regulated pharmaceutical and biotech environments, with… more
- Merck & Co. (Rahway, NJ)
- …manufacturing (molding and assembly) is preferred but not required.Proficient in computer -aided design (CAD) and computer -aided engineering (CAE) software such ... Work Arrangements:HybridShift:Not IndicatedValid Driving License:NoHazardous Material(s):N/ARequired Skills:Analytical Method Development, Computer -Aided Design (CAD), Computer -Aided Design And Drafting… more
- Merck & Co. (Durham, NC)
- …supplies and products needed to support manufacturing. - Operates various computer -controlled process support/process equipment ( ie washer, autoclave, vial filler, ... - Completes in-process testing and inspections supporting the vaccine manufacturing, validation , and development processes as required . - Identifies and addresses… more
