- Actalent (Santa Ana, CA)
- …and assist in process development and troubleshooting. Responsibilities + Maintain the validation program for computer systems , facilities, equipment, and ... industry is preferred. + Familiarity with GMP procedures and requirements, including Quality Systems and cGMP requirements ( FDA , EU, ICH). + Ability to assess… more
- Cognizant (San Francisco, CA)
- …value chain, Products/ Platforms used. + Knowledge of FDA regulations for Computer system validation , Medical Device regulations, GAMP 5 + Knowledge ... of Test Automation, Understanding of Gen AI will be a plus. + Experience and proven track record of dealing with IT, business, C level executives. + Well-rounded consultant with the ability to cross-sell, up-sell across all functional areas. + Ability to… more
- Vera Therapeutics (Brisbane, CA)
- …gathering, configuration, testing, and deployment. * Partner with QA to develop and maintain Computer System Validation (CSV) documentation per GAMP5 and 21 ... Systems and will be responsible for leading the implementation, validation , and support of GxP-regulated systems to enable Quality, Regulatory,… more
- Abbott (Pleasanton, CA)
- …related discipline + 8+ years of experience in a similar position, including system verification and validation , systems integration experience, software ... The Staff Systems Verification Engineer will be accountable for delivering system verification across the full CardioMEMS system in support of multiple… more
- Abbott (Pleasanton, CA)
- …tests, and integrates components, disciplines, and products within the CardioMEMS HF System , including implantable sensors, external reader systems used by ... generation products, including requirements definition and management, design documentation, and system testing, verification, and validation . **What You'll Work… more
- VTI Life Sciences (San Diego, CA)
- …of the biggest companies in the Life Sciences industry. We are looking for a Computer System Validation (CSV) Specialist to be responsible for ensuring that ... + 3+ years of proven experience with SQL, Software Validation and Computerized Systems Validation ....Validation . + Must have experience working in an FDA -regulated environment. + Experience with Automation Equipment such as… more
- Gilead Sciences, Inc. (Santa Monica, CA)
- …CGTO & SAP SD, MM & PP modules, regulatory compliance (such as GxP and FDA ), and life sciences Quality Management and Batch Release processes. As an SAP CGTO ... processes, ensuring seamless integration with SAP S/4HANA and other related systems (SFHC - upstream, MES, Robar/Bartender - downstream) and driving business… more
- Terumo Neuro (Aliso Viejo, CA)
- …method validation and data analysis. 3. Demonstrated command and knowledge of FDA and ISO medical device quality system requirements. 4. Proven experience in ... risk assessments and FMEAs. + Lead activities in various Quality Systems such as CAPA, Non-Conformance (NCR), supplier quality, equipment calibration, internal… more
- Abbott (Sylmar, CA)
- …issues. + Validation : Create and execute or direct software validation protocols traceable to system /software requirements. + Change Management:Implement ... + Work with Design and Manufacturing Engineering in the completion of system /software requirements and other verification and validation processes. + Create… more
- Abbott (Alameda, CA)
- …oversees the design, development, and validation of software for embedded systems , ensuring compliance with FDA requirements. They play a crucial role ... addressing moderate scope problems. + Participate in software development, verification, and validation under guidance. + Adhere to FDA -compliant Design Control… more