- Philips (San Diego, CA)
- …internal policies throughout the software lifecycle. + Authorizes/Leads the assessment, validation and approvals of software designs/inputs, overseeing the review of ... and Ensures Risk Management is effective utilizing feedback from validation , field service, post market surveillance, manufacturing indicators, CAPAs, HHAs,… more
- Kelly Services (Irvine, CA)
- …for manufacturing, test method development, and product verification and validation testing._ + _Support engineering by researching, designing, developing, and ... OR environment, with a cross-functional team_ + _Support the design reviews and pre- validation assessments to ensure the safe and efficacious design and processes_ +… more
- Gilead Sciences, Inc. (Santa Monica, CA)
- …oversight for the design, installation, commissioning, qualification, and validation of facilities, equipment, and utilities, leveraging engineering standards, ... Quality by Design principles, and experience aligned with FDA , ICH, & ISPE guidelines. + Ensure all activities comply with current Good Manufacturing Practices… more
- Capgemini (Sylmar, CA)
- …teams including manufacturing, quality, and IT. + Ensure system compliance with FDA , ISO 13485, and GxP standards. + Troubleshoot and resolve MES-related issues ... in a timely manner. + Document technical specifications, configurations, and validation protocols. **Your Skills and Experience** + Expertise in Rockwell FactoryTalk… more
- Actalent (Irvine, CA)
- …responsible for developing and maintaining SOPs related to the establishment and validation of marketing claims, with a focus on different user populations. ... marketing claims. + Organize and document findings to support traceability and validation efforts with the internal project team. + Investigate and validate… more
- Insight Global (San Jose, CA)
- …Skills and Requirements 2+ years of experience in manufacturing test method validation Strong understanding of process qualification and validation (IQ/OQ/PQ) ... industry, with solid understanding of regulatory standards (eg, PFMEAs, IQ protocols, FDA compliance) Proficiency in Python and ideally the Pytest framework -… more
- Sumitomo Pharma (Sacramento, CA)
- …signal management throughout product lifecycle including signal detection, signal validation , signal escalation, development of risk mitigation strategies and ... aggregate review of post-marketing safety data in support of safety signal validation , trend detection, risk benefit management, and development of risk mitigation… more
- Cordis (Irvine, CA)
- …+ Develop, and qualify new tooling and equipment. + Verification and validation of processes, machines, and equipment to meet requirements of Company procedures. ... + Ability to make independent decisions + Knowledge of validation verification process, Gage R&R, and a clear understanding...verification process, Gage R&R, and a clear understanding of FDA 's QSR and GMP + Proficiency in SolidWorks and… more
- BD (Becton, Dickinson and Company) (San Diego, CA)
- …also to possess an in-depth knowledge of product characterization, verification and validation activities, as well as the regulatory landscapes that guide these ... also to possess an in-depth knowledge of product characterization, verification and validation activities, as well as the regulatory landscapes that guide these… more
- IQVIA (Valencia, CA)
- …Test clinical study databases in alignment with programming standards and validation procedures + Contribute solutions and insights independently to development and ... validation project teams + Coordinate testing plans and execute...+ Proficiency in laboratory terminology and regulatory standards including FDA , GLP, ICH, ISO HL7 + Excellent problem-solving and… more