Validation Engineer
Job Summary
MOH : W2
Exp : 10-15
Location : Altanta,GA
A Validation Engineer ensures that systems, equipment, processes, and software meet regulatory standards, technical requirements, and quality guidelines. They execute validation activities such as IQ/OQ/PQ, draft validation protocols, analyze results, and maintain compliance documentation—commonly in pharmaceutical, biotech, medical device, or manufacturing industries.
Key Responsibilities
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Develop and execute Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) protocols
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Perform equipment, process, and software validation
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Prepare and maintain validation documentation (plans, reports, risk assessments)
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Ensure compliance with GMP, FDA, ISO, and industry regulations
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Investigate deviations and implement corrective actions
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Support audits and regulatory inspections
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Collaborate with engineering, quality, and manufacturing teams
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Conduct change control impact assessments
Required Skills
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Strong understanding of GMP, GLP, FDA 21 CFR Part 11, EU Annex 11
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Knowledge of CQV (Commissioning, Qualification, Validation)
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Experience with validation tools/ protocols
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Risk assessment and root-cause analysis
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Documentation and technical writing
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Attention to detail and problem-solving
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Experience with equipment or software validation (PLC, SCADA, MES, CSV)