- 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
- Sumitomo Pharma (Sacramento, CA)
- …drug/device combination products) is required. Must be familiar with EMA and FDA validation requirements, including Lifecycle Model. Lean Six Sigma ... and experienced individual for the position of **Director, Commercial Manufacturing Validation ** . This role functions within SMPA's Global Technology and Quality… more
- J&J Family of Companies (Santa Clara, CA)
- …as medical devices, pharmaceuticals, biotechnology. + Strong knowledge of software validation and Computer Software Assurance (CSA) principles, including ... and maintained in a compliant state using a risk-based Computer Software Assurance (CSA) approach. The role acts as...11, 21 CFR Part 820, EU Annex 11, and FDA software validation guidance. + Experience supporting… 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
- 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
- MetaOption, LLC (Sunnyvale, CA)
- …under FDA regulations. * Familiarity with quality management systems, validation procedures, and documentation for regulatory audits and FDA submissions. ... ensure reliability, scalability, and compliance of critical systems in alignment with FDA GxP guidelines and HITRUST standards for healthcare data protection. You… 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 (Pomona, CA)
- …new products/processes and changes to existing products/processes develop verification and validation plans that assess if requirements are met. + Responsible for ... in their area of responsibility, including product design, verification and validation , manufacturing and testing activities. + Carries out duties in compliance… more
- Oracle (Sacramento, CA)
- …applying medical device standards (including IEC 62304, IEC 82304, and FDA guidance), define software interfaces, manage traceability across the system lifecycle, ... device software, ensuring vulnerability management and cybersecurity compliance with FDA and global regulatory expectations. + Apply the organization's Risk-Based… more