- Insmed Incorporated (NJ)
- …retirement) to ensure compliance with FDA, ICH, and EU regulations.Review and approve computer system validation (CSV) deliverables (eg, URS, FS, validation ... Clinical Practice (GCP) E6(R3), Computerized Systems Used in Clinical Trials, Computer System Validation , Quality Management Systems ProcessesWho You… more
- Aequor (Davie, FL)
- …Ensure systems meet GxP, FDA, and ISO standards through robust Computer Systems Validation (CSV) and documentation practices. Cross-Functional Collaborationo ... of digital tools. Qualifications: Education: Master's degree in electrical engineering, Computer Science, Automation, Robotics or related field. Ph.D. With less… more
- Merck & Co. (Rahway, NJ)
- …Adaptability, Analysis Reports, Analytical Instrumentation, Chemical Engineering, Chemical Technology, Computer System Validation (CSV), Data Analysis, Equipment ... Maintenance, Experimentation, GMP Compliance, GMP Environments, Good Manufacturing Practices (GMP), Internal Audit Controls, Interpersonal Communication, Inventory Management, Manufacturing Support, Metrology, Oral Communications, Personal Initiative,… 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 20%) Candidates near Eisai's NJ/PA location will be preferred. For candidates near an Eisai location, Remote Work Arrangement will consist of 2-4 days in office (Nutley/Exton) per month and 1-2 audits quarterly; remote audits, are held in… 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
- Aequor (Davie, FL)
- …with a focus from University of Miami, FAU, FIU fresh Ph.Ds , and computer science/ automation Master's degree from FAU and FIU.Shift Schedule: Monday - Friday 8 ... Review and analysis of the analytical and statistical data to support the pre- validation work. Analysis of data to ascertain the data meets protocol and product… more
- BioAgilytix (Durham, NC)
- …In this role, you will take ownership of assay development, validation , and sample analysis using advanced chromatographic and mass spectrometric techniques. ... shape the future of healthcare.Essential Responsibilities:Independently lead assay development, validation , and sample analysis of biologics, proteins, peptides, ADCs,… 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 (Durham, NC)
- …best suited for someone with deep expertise in method development, GxP-compliant validation , and both 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 ... with clients to assure successful on time execution of assays, validation , and sample analysis under GxPs.Prioritizing tasks and managing schedules efficiently.Meet… more
- AUROBINDO (Durham, NC)
- …consistently good decisions.Must be able to perform Cleaning Verification/ Validation swabbing.A familiarity with cGMPS, CFRs and FDA regulations.Compensation: ... hear, and use hands and fingers to operate a computer and telephone keyboard reach, stoop kneel to install... and telephone keyboard reach, stoop kneel to install computer equipment Specific vision abilities required by this job… more
- Merck & Co. (North Wales, PA)
- …metadata generated from these collections.Embed automated quality control checks and validation rules directly into data pipelines, ensuring our data assets meet ... 8 years) or Ph.D. (with 4 years) in bioinformatics, computer science, data science, engineering, data analytics, life sciences...backed by an advanced degree in a field like Computer Science, Data Engineering, or Bioinformatics, which you're eager… more
- Insmed Incorporated (NJ)
- …functional documentationCreate user stories and highlight process gapsSupport testing and validation of user stories and business processesContribute to reports and ... You are a current student working on a Bachelor's degree in Business, Computer Science, or related field.You are or you have: Strong analytical and problem-solving… more
- Insmed Incorporated (San Diego, CA)
- …EDC System Design & Development: Lead the setup, development, and validation of EDC systems, including configuration settings, integration with other applications, ... FDA, EMA, ICH-GCP) and company SOPs.Perform user acceptance testing (UAT) and validation of EDC systems to ensure data integrity and accuracy.Implement and monitor… more
- Merck & Co. (Rahway, NJ)
- …lifecycle. Primary Activities :Effective analysis and report programming development and validation utilizing global and TA standards and following departmental SOPs ... strategic initiative teams Education and Minimum Requirement :BA/BS in Computer Science, Statistics, Applied Mathematics, Life Sciences, Engineering or related… more
- Aequor (South San Francisco, CA)
- …complex datasets for deeper analysis.Contribute to the design, implementation, and validation of predictive models using machine learning and statistical techniques ... to client and internal audiences.RequirementsCore QualificationsBachelor's degree in Statistics, Computer Science, Data Science, Psychology, or another field with a… more
- BioAgilytix (Durham, NC)
- …Part 11).Business continuity and resilience (eg, backup/restore validation , disaster recovery planning).Minimum Preferred Qualifications - ... Education/Experience:Bachelor's degree in information security/ computer science or related field required;Required certification(s): CISSP/CISM, Azure Security… 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 ... initiative teams- Skills: Education and Minimum Requirement: BA/BS in Computer Science, Statistics, Applied Mathematics, Life Sciences, Engineering or related… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …training program for Operations (Manufacturing, Warehouse, Facilities & Engineering, Validation , Technical Support, Supply Chain) that supports daily clinical ... instructional design and Train-the-Trainer programsCurriculum and module design experienceAdvanced computer skills and practical knowledge of MS Office Suite,… more
- Regeneron Pharmaceuticals (Cambridge, MA)
- …providing validation documentation and explanations and communicates company's computer validation policies. + Generating, reviewing, editing, and approving ... We are seeking a highly skilled, self-motivated **Senior Validation Specialist- CSV** to ensure compliance of computerized...role, you must have at least a** BS/BA in Computer Science, Engineering, Chemistry, or Life Sciences and 5+… more
