Computer System Validation Engineer Job at Stark Pharma Solutions Inc, Indianapolis, IN

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  • Stark Pharma Solutions Inc
  • Indianapolis, IN

Job Description

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

Job Tags

Long term contract, Full time, Local area

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