CSV Engineer Jobs in California

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CSV Engineer

Katalyst Healthcares and Lifesciences

•

Santa Clara, California, USA

Full-time

Roles & Responsibilities: Knowledge in Troubleshooting MATLAB compatibility issues and technical issues. Strong Experience in CSV. Strong creative, analytical and problem-solving skills. Experience in PLM Tool. Excellent Interpersonal / communication skills, Organizational / planning skills preferred. Personal computer skills, Windows: word processing, presentation, e-mail, web browsers & spreadsheet software. Ability to work efficiently, meet timelines, and communicate status (generate t
Posted 4 days ago | Updated 10 hours ago

CSV/ CSA Engineer

Katalyst Healthcares and Lifesciences

•

San Francisco, California, USA

Full-time

Job Description: The CSA Engineer will be responsible for ensuring that all computer systems, software applications, and related processes comply with industry standards and regulatory requirements, especially in regulated environments such as pharmaceutical, biotech, and healthcare sectors. Responsibilities: 10 Plus Years of experience in Computer System Assurance (CSA) or Computer System Validation (CSV) in regulated industries such as pharmaceuticals, medical devices, or biotechnology. Stron
Posted 47 days ago | Updated 10 hours ago

Sr. Validation Engineer (CSV)

Katalyst Healthcares and Lifesciences

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California, USA

Full-time

Responsibilities: Create and execute Computer System Validation (CSV) deliverables (Validation Plans, Protocols, Reports, Trace Matrices, SOPs). Collaborate with Business Users, System Owners, IT teams, and Analysts to define validation requirements. Provide leadership and training in validation activities. Generate IQ/OQ/PQ protocols using Good Documentation Practices (GDP). Ensure compliance with quality system elements for computer systems/software testing. Perform gap assessments and remedia
Posted 47 days ago | Updated 10 hours ago

Computer System Validation Analyst - R Studio & Clinical Systems

Katalyst Healthcares and Lifesciences

•

Remote or New Jersey, USA

Full-time

Responsibilities: Lead validation planning, risk assessment, and execution for R Studio, GitLab, and Medidata Rave EDC. Develop and execute validation documentation including: Validation Plans (VP.). User Requirements Specifications (URS.). Risk Assessments (RA.). Functional and Design Specifications. Traceability Matrix (RTM.). Test Protocols (IQ/OQ/PQ or CSA-based scripts.). Validation Summary Reports (VSR.). Collaborate with cross-functional stakeholders including Clinical Data Mana