More jobs:
Computer System Validation Engineer
Job in
Indianapolis, Hamilton County, Indiana, 46262, USA
Listed on 2026-05-10
Listing for:
Stark Pharma
Full Time
position Listed on 2026-05-10
Job specializations:
-
Engineering
Validation Engineer, Pharma Engineer
Job Description & How to Apply Below
Job Title: Validation Engineer
Location: Indianapolis / Bloomington, IN (100% Onsite)
Duration: Long term Contract
Interview Mode: Onsite (Local candidates preferred)
OverviewWe 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
- 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
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