- Amgen (South San Francisco, CA)
- …degree OR Bachelor's degree and 2 years of Life Sciences, Bioinformatics, Computer Science, Information Systems, or related field experience Or Associate's degree ... and 6 years of Life Sciences, Bioinformatics, Computer Science, Information Systems, or related field experience Or High school diploma / GED and 8 years of Life… more
- Stryker (San Jose, CA)
- …Stryker's global Digital Health Portfolio. + Support software design and validation efforts by ensuring documentation aligns with Quality Management Systems ... for digital health products, ensuring compliance with global regulatory standards ( FDA , TGA, EUMDR). + Participate in software lifecycle reviews, promoting… more
- BeOne Medicines (Emeryville, CA)
- …of staff in support of clinical trials, ad-hoc analysis requests, data validation , etc. in accordance with all relevant statistical regulatory guidance and ... and follow specifications to create SDTM and ADaM datasets (as needed) + Computer programming using SAS + PC literacy required; MS Office skills (Outlook, Word,… more
- Actalent (Irvine, CA)
- …+ Assist in the development and review of process and equipment validation and qualification. + Participate in manufacturing transfers to other plants or ... Ability to work independently and as part of cross-functional teams. + Computer literacy. Additional Skills & Qualifications + Previous industry experience is… more
- Actalent (Huntington Beach, CA)
- …years of experience in PLCs, Rockwell Automation, SCADA, Inductive Automation Ignition, FDA validation , DCS, DeltaV, electrical schematics, and control panels. ... Additional Skills & Qualifications + Understanding of DCS hardware/software platforms such as Emerson DeltaV or similar. + Knowledge of S88 Batch/Recipes, OEE, MES, and ERP systems. + Experience in designing electrical schematics and control panels. +… more
- Aerotek (San Diego, CA)
- …in machine operation, multitasking, quality assurance, packaging, inspection, and computer operation. **Additional Skills & Qualifications** + At least two ... coagulation-based manufacturing processes. + Knowledge of Good Laboratory Practices (GLP), FDA regulations, and ISO standards. + Working knowledge of Microsoft… more
- Eurofins (Davis, CA)
- …clean laboratory instruments and equipment + When time permits, provide assistance to Validation Specialists and aide in the kit assembly process To perform this job ... position preferred + Previous ELISA and/or Western Blot testing experience preferred Computer Skills + Basic knowledge of Microsoft Word, Excel, and Outlook. +… more
- Mentor Technical Group (South San Francisco, CA)
- …provides a comprehensive portfolio of technical support and solutions for the FDA -regulated industry. As a world leader in life science engineering and technical ... interoperability. + Ensure data quality, accuracy, and integrity through robust validation and monitoring practices. + Manage data sources across categories such… more
- Curia (Camarillo, CA)
- …transfers, and validations + Perform QC method development + Perform cleaning validation studies + Assist with the evaluation of new equipment and processes ... deal with several abstract and concrete variables + Proficient use of computer software, including Microsoft Office Suite and instrument manufacture-based systems +… more
- LEMO Group (Rohnert Park, CA)
- …active lead in design for Manufacturability / Assembly Responsible for tool & process validation (PPAP), DQ, IQ, OQ, PQ. + Perform PFMEA Risk Analyses when required ... + Familiarity with IPC 610/620 standards, ISO 9001, ISO 13485, FDA Physical Job RequirementsQualifications/Skills: + Typical Working Conditions: Office environment,… more