- Cordis (Irvine, CA)
- …implement practical business solutions under multiple deadlines. + Participate and provide GxP validation support during FDA Computer Software Validation ... user stories, and test scripts; proficient with SQL for data validation . + Excellent facilitation, communication, and stakeholder-management skills. + Motivated to… more
- Genentech (Oceanside, CA)
- …automated pharmaceutical drug substance facility. The site employs highly integrated computer control systems to manage plant operations and manufacturing data. The ... you will have responsibilities for IT OT compliance and Validation ensure compliance for all IT Systems. As part...Represent ITOT in internal(SSI, GARA, quality etc.) and external audits( FDA etc.). + "Right to Operate" : Manage ITOT… 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
- VTI Life Sciences (San Diego, CA)
- …the biggest companies in the Life Sciences industry. We are looking for a Computer System Validation (CSV) Specialist to be responsible for ensuring that ... in compliance with industry standards, regulatory requirements (such as FDA 21 CFR Part 11 and 820, Data Integrity,...Validation . + Must have experience working in an FDA -regulated environment. + Experience with Automation Equipment such as… 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 ... of people. This role oversees the design, development, and validation of software for embedded systems, ensuring compliance with... of software for embedded systems, ensuring compliance with FDA requirements. They play a crucial role in software… more
- Terumo Neuro (Aliso Viejo, CA)
- …quality assurance such as design control, risk analysis, design verification, design validation , process validation , test method validation , statistical ... + Work with R&D on design verification and design validation testing of new products. + Work with R&D...and data analysis. 3. Demonstrated command and knowledge of FDA and ISO medical device quality system requirements. 4.… more
- Abbott (Alameda, CA)
- …addressing moderate scope problems. + Participate in software development, verification, and validation under guidance. + Adhere to FDA -compliant Design Control ... **The Opportunity** The Embedded Software Engineer oversees 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
- Abbott (San Diego, CA)
- …clear and accurate records of experiments in a laboratory notebook and engineering/ validation reports. + Generate and present projects, both in depth and high ... + Knowledgeable of federal and other regulations, eg QSR's, ISO, and FDA . + Demonstrate commitment to the development, implementation and effectiveness of the… more