- Cardinal Health (Sacramento, CA)
- …solutions. You will develop and deploy software code and solutions that comply with FDA computer systems validation methodology. The Medical Segment IT ... the design, development, and deployment of software solutions aligned with FDA computer systems validation (CSV) methodologies. + Define technical… more
- Grifols Shared Services North America, Inc (Los Angeles, CA)
- …than 110 countries and regions. **_Job Summary:_** Responsible for conducting validation studies in accordance with current industry standards and guidelines for ... the qualification and validation of manufacturing systems and supporting processes. **_Essential Job...+ Strict adherence to procedures and practices according to FDA regulations. + Strong emphasis on documentation according to… more
- Takeda Pharmaceuticals (Thousand Oaks, CA)
- …risk assessments, traceability matrices, and validation master plans. + Develop validation protocols (IQ/OQ/PQ) for computer systems as applicable to its ... MES, ERP, SCADA, or DCS (eg, Delta V) for computer systems validation engineers. + Advanced knowledge...required. + Familiarity with software development lifecycle (SDLC) and validation tools. + Knowledge of GAMP 5, FDA… more
- Amgen (Thousand Oaks, CA)
- …+ Broad working knowledge of key IS domains and layers + Understanding of FDA regulations governing computer system validation and operation + Familiarity ... with security requirements and best practices for data at rest and in transit + Success in mentoring and developing strong product analysts, business analysts, and developers + Experience in FMCG/CPG/Retail/Manufacturing industry **Professional… more
- Insight Global (San Francisco, CA)
- …ISO 14971 o GAMP5 guidelines, FDA guidance on risk-based software validation and computer software assurance * Proven Experience with software development ... ensure systems are validated and maintained in their validated state. * Maintain computer system inventory * Ensure validation documentation are retained per the… more
- Terumo Neuro (Aliso Viejo, CA)
- …quality assurance projects and activities to meet the sterilization validation requirements of medical products. Lead sterilization process commissioning, initial ... sterilization validation and re- validation activities. Provide technical support...Provide sterilization expertise during interface with regulatory agencies, including FDA and ISO. + Support clean room monitoring and… more
- Abbott (San Diego, CA)
- …problems of moderate scope. Participate in software development, verification, and validation activities under guidance Adhere to FDA -compliant Design Control ... for millions of people. This role participates in the design, development, and validation of software for embedded systems, ensuring compliance with FDA … more
- Abbott (Sylmar, CA)
- …and training to the site engineers for Non-Product Software development and validation , Data Integrity, Cybersecurity, 21 CFR part 11 requirements and ensure ... Engineering in the completion of system/software requirements and other verification and validation processes. + Create and execute or direct software validation … more
- Terumo Neuro (Aliso Viejo, CA)
- …accurate, high quality clinical data and adhering to Good Clinical Practices and FDA regulations. Job duties: + Develop and implement SOPs to ensure GCP/ICH ... as appropriate. + Assure regulatory compliance of vendors with company SOPs, FDA and ICH guidelines and other applicable regulations and guidelines. + Review… more
- Abbott (Pleasanton, CA)
- …in regulated industries (medical devices, pharma, healthcare). + Knowledge of FDA software validation processes. + Experience with real-time monitoring ... Security** : Ensure systems meet regulatory standards (eg, HIPAA, FDA CFR Part 11, ISO 13485). + **Observability** :...into application design. + Work closely with QA and validation teams to support software verification and validation… more
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