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Quality Assurance Validation Engineer – Pharma
Job in
Columbus, Franklin County, Ohio, 43224, USA
Listed on 2026-07-06
Listing for:
Intellectt Inc
Full Time
position Listed on 2026-07-06
Job specializations:
-
Quality Assurance - QA/QC
Quality Engineering, Regulatory Compliance Specialist, QA Specialist - Analyst/Manager -
Pharmaceutical
Quality Engineering, Regulatory Compliance Specialist, Pharma Engineer
Job Description & How to Apply Below
We are seeking a Quality Assurance Validation Engineer with 2+ years of pharmaceutical industry experience to support validation and quality assurance activities in a GMP-regulated environment. The ideal candidate will have hands-on experience with validation protocols, quality systems, and regulatory compliance.
Key Responsibilities- Support validation activities including IQ, OQ, PQ, and process validation.
- Review and approve validation protocols, reports, and GMP documentation.
- Ensure compliance with FDA, cGMP, and 21 CFR Part 11 requirements.
- Assist with deviations, CAPAs, change controls, and risk assessments.
- Collaborate with Manufacturing, Engineering, and Quality teams during validation projects.
- Maintain validation documentation and support audit/inspection readiness.
- Bachelor's degree in Engineering, Life Sciences, or a related field.
- 2+ years of Quality Assurance and Validation experience in the pharmaceutical industry.
- Experience with IQ/OQ/PQ, process validation, and GMP documentation.
- Knowledge of FDA regulations, cGMP, and quality systems.
- Strong documentation, communication, and problem-solving skills.
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