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.

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J&J Experience:

Previous Johnson & Johnson (J&J) experience highly preferred.