Engineering

CSV Engineer

XZIANTRaritan, NJ🇺🇸United States

Why this role stands out

Elevate your career as a CSV Engineer at XZIANT, a company known for its innovative work in regulated industries, where you'll gain valuable experience in a hybrid environment that fosters growth. If you thrive on applying your expertise in validation and regulatory standards to impactful projects and enjoy collaborating with talented teams, this opportunity is for you. Apply today to contribute to cutting-edge solutions and advance your professional journey.

Quick overview

SeniorityMid Senior

Work modeHybrid

LocationRaritan, NJ, United States

Job description

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.