CSV Automation Engineer — FDA-Regulated Validation Expert

VTI Life Sciences; United States; On-site; USD 80,000 - 105,000; Full time

Benefits offered by this job

401(k) matching

Professional development and training

Comprehensive benefits package

Job summary

A leading life sciences company in the United States is seeking a Computer System Validation (CSV) Specialist to ensure compliance with FDA regulations and industry standards. The ideal candidate will possess a bachelor's degree, 7+ years of relevant experience, and expertise in Software Validation. This full-time role offers competitive compensation and professional development opportunities in a collaborative environment.

Qualifications

• 7+ years of experience in FDA-regulated industry.
• Expertise in 21 CFR Part 11 and ISO 13485.
• Familiarity with Test Scripts and databases.

Responsibilities

• Develop test plans and execute qualification activities.
• Draft and review User Requirement Specifications.
• Conduct manual and automated testing.

Skills

Software Validation

Regulatory Compliance

Technical Writing

SQL Knowledge

Education

Bachelor’s degree in Engineering or Life Sciences

Tools

Oracle Agile

Jira

Valgenesis

Job description

A leading life sciences company in the United States is seeking a Computer System Validation (CSV) Specialist to ensure compliance with FDA regulations and industry standards. The ideal candidate will possess a bachelor's degree, 7+ years of relevant experience, and expertise in Software Validation. This full-time role offers competitive compensation and professional development opportunities in a collaborative environment.