Computer System Validation Engineer
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Job Location:
Indianapolis, IN - USA
Monthly Salary:
Not Disclosed
Posted on:
3 hours ago
Vacancies:
1 Vacancy
Job Summary
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:
- Bachelors 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
