- 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
- 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
- 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
- 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)
- …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 (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
- Rocket Lab Corporation (Long Beach, CA)
- …II/ Senior Spacecraft Structural Analysis Engineer I contributes to the analysis, design validation , and future improvements of our suite of Space Systems and Space ... & flight data, including: sensor selection, data acquisition and validation , and environmental determination (random vibration, shock, quasi-static, acoustic,… more
- Columbia Technology Partners (Annapolis Junction, MD)
- …position is contingent on contract award** Description: Conduct verification and validation for security compliance of low and moderately complex information ... coordinate penetration testing, and provide a comprehensive verification and validation report (certification report) for the information system. Provide process… 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
- 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
- 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
- Raytheon (Marlborough, MA)
- …the development of Risk Management Framework (RMF) documents and controls validation testing for Authority to Operate (ATO) accreditationsSupport the development of ... are eligible for a security clearanceExperience in the fields of computer technology, cybersecurity, Anti Tamper, or other systems security engineering fields… 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
- Airlite Plastics (Nazareth, PA)
- …extrusion and injection molding preferred. *Experience in manufacturing operations, process validation , and design of experiments is required. KNOWLEDGE, SKILLS & ... cost reduction, and SPC systems. *Experience with process development, optimization, and validation and design of experiments and statistics. *Ability to learn new… 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
- Commvault (Fort Lauderdale, FL)
- …to provide services to accelerate and advance opportunities through the technical validation cycle. Architect solutions built on the Commvault solution aimed at ... facilitate knowledge transfer and efficiency. Position Requirements Bachelor's degree in computer science, engineering, or equivalent. 4+ years of experience in… more
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