Computer System Validation Engineer

Job Title: Validation Engineer

Location: Indianapolis / Bloomington, IN (100% Onsite)

Duration: Long term Contract

Interview Mode: Onsite (Local candidates preferred)

Job Summary

We are seeking a Validation Engineer with strong experience in Computer Systems Validation (CSV), equipment qualification, and GMP-regulated environments. The ideal candidate will support validation activities, documentation migration, and equipment qualification to ensure compliance with regulatory standards.

Key Responsibilities

• Lead migration of legacy validation documents into the Kneat digital platform, ensuring accuracy and compliance
• Perform equipment qualification for lab instruments (pH meters, thermal mixers, peristaltic pumps, nutating mixers, etc.)
• Execute temperature mapping studies, including work with Ellab systems or similar equipment
• Support Computer Systems Validation (CSV) activities and documentation
• Assist Process Engineering teams to ensure project timelines and milestones are met
• Ensure all validation activities comply with GMP and regulatory requirements
• Maintain clear, accurate, and compliant documentation
  
  

Required Qualifications

• Bachelor s degree in Engineering, Science, or related field
• 6 years of experience in Computer Systems Validation (CSV)
• 4 years of experience in pharmaceutical manufacturing environment
• Hands-on experience with equipment qualification and validation
• Strong knowledge of CSV principles and regulatory compliance
• Experience working in onsite, fast-paced environments