CSV Engineer

Job Summary for CSV Engineer

• Industry Experience: 3-7+ years of relevant experience in pharmaceutical, biotechnology, or medical device industries.
• System Development Lifecycle: Proficient in Computer System Validation (CSV), especially in FDA and/or globally regulated environments.
• Regulatory Standards: Strong understanding of GxP standards, risk-based validation, FDA guidances, and industry standards (e.g., GAMP).
• Validation Documentation: Skilled in writing and executing validation deliverables, including requirements, validation plans, test protocols, summary reports, and compliance reports.
• Testing & QA: Experience in reviewing system test and user acceptance test (UAT) scripts, traceability matrices, and design specifications; familiar with QA methodologies and automated test scripts.
• Team Leadership: Ability to work independently, mentor junior team members, lead teams, and collaborate with remote teams.
• Communication: Excellent verbal and written communication skills.
• Project Management: Capable of managing multiple projects/changes simultaneously, providing validation guidance, and escalating issues as needed.
• Technical Skills: Hands-on experience with validation of data solutions (Data Lakes, Data Warehouses); familiarity with Snowflake and Databricks preferred.
• J&J Experience: Previous Johnson & Johnson (J&J) experience highly preferred.