- Cordis (Irvine, CA)
- …practical business solutions under multiple deadlines. + Participate and provide GxP validation support during FDA Computer Software Validation activities ... user stories, and test scripts; proficient with SQL for data validation . + Excellent facilitation, communication, and stakeholder-management skills. + Motivated to… more
- AbbVie (Irvine, CA)
- …computerized systems, used within the R&D laboratory function associated with FDA Good Manufacturing Practices (GMP) testing for biological and small molecule ... projects. + Responsible for the planning, design and implementation of validation projects, coordination of validation activities, and preparation of … more
- VTI Life Sciences (San Diego, CA)
- …Life Sciences industries. We are looking to staff a highly motivated Validation Specialist/ Engineer 1 responsible for delivering commissioning, qualification, and ... validation (CQV) services related to equipment, instruments, and systems...reporting is a plus. + Previous experience in a cGMP/ FDA -regulated manufacturing environment is a plus. + Must be… more
- Meta (Burlingame, CA)
- **Summary:** We're seeking a Product Verification and Validation Engineer to join our medical devices compliance team, focusing on wearables and Software as a ... and reliability of our products, particularly in areas such as:* Sensor validation : Working with advanced sensors, such as electrodermal activity (EDA) sensors,… more
- Cognizant (San Francisco, CA)
- …+ Understanding of Pharma 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. +… more
- Otsuka America Pharmaceutical Inc. (Sacramento, CA)
- …operations. + Experience with cGMP manufacturing environments and regulatory requirements ( FDA , EMA, ICH). + Familiarity with process validation principles ... and compliance of downstream operations through effective technology transfer, validation support, process monitoring, troubleshooting, and lifecycle management activities… more
- VTI Life Sciences (San Diego, CA)
- …Systems Validation . + Must have experience working in an FDA -regulated environment. + Experience with Automation Equipment such as HMI's, Robotized Manufacturing ... 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,… more
- Abbott (Alameda, CA)
- …with all applicable regulatory and Abbott corporate requirements. (Such as, ISO 13485 and FDA 21 CFR part 820, and IVD/MDD directives). Will manage and serve as ... management on software related projects. Develop and implement Verification and Validation policies, status reports, and strategies. Review and approve validation… more
- Gilead Sciences, Inc. (Foster City, CA)
- …expertise in SAP BRH & SAP QM module, regulatory compliance (such as GxP and FDA ), and life sciences Quality Management and Batch Release processes. As an SAP BRH ... Sciences manufacturing operations, ensuring alignment with industry regulations such as GxP, FDA , and 21 CFR Part 11. Design scalable, efficient, and compliant… 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 ... Sciences manufacturing operations, ensuring alignment with industry regulations such as GxP, FDA , and 21 CFR Part 11. Design scalable, efficient, and compliant… more