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Sr. Validation Engineer
Job in
Indianapolis, Marion County, Indiana, 46262, USA
Listed on 2025-12-01
Listing for:
Harba Solutions Inc.
Full Time
position Listed on 2025-12-01
Job specializations:
-
Engineering
Quality Engineering -
Quality Assurance - QA/QC
Quality Engineering
Job Description & How to Apply Below
Job Responsibilities:
- Lead equipment, facility, utility, and process validation activities (IQ/OQ/PQ)
- Author, review, and execute validation protocols and summary reports
- Ensure compliance with FDA, EMA, and cGMP regulations
- Collaborate cross-functionally with Quality, Manufacturing, and Engineering teams
- Drive continuous improvement in validation strategies and risk-based approaches
- Bachelor’s degree in Engineering, Life Sciences, or related field
- 4+ years of validation experience in a CDMO, pharma, or biotech environment
- Strong knowledge of GMP validation requirements and risk-based validation (e.g., ASTM E2500)
- Experience with cleanroom validation, autoclaves, SIP/CIP, and process equipment
- Excellent technical writing and communication skills
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