We are seeking a proactive
Validation Engineer
with 1–3 years of experience in a regulated manufacturing environment such as medical devices, pharmaceuticals, or biotechnology. This on-site role focuses on process validation activities to ensure compliance with FDA, ISO, cGMP, and internal quality standards while supporting continuous improvement and operational excellence.

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  Develop, write, review, and execute process validation and process verification protocols and reports
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  Conduct risk assessments and support validation strategies for new and existing manufacturing processes
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  Analyze and interpret validation data to ensure compliance with regulatory and internal quality requirements
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  Collaborate with Manufacturing, Quality, and Design Transfer teams to resolve validation issues and implement corrective actions
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  Support process optimization and continuous improvement initiatives to improve quality and efficiency
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  Ensure compliance with FDA, ISO, cGMP, and internal regulatory standards
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  Maintain validation documentation, traceability records, and audit-ready files
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  Provide training and guidance on validation processes, procedures, and compliance requirements

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  Bachelor’s degree in Engineering, Life Sciences, or related field
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  1–3 years of experience in validation within a regulated manufacturing environment
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  Knowledge of process validation principles, verification techniques, and industry standards
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  Familiarity with FDA regulations, ISO standards, and cGMP requirements
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  Strong technical writing, analytical, and problem-solving skills
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  Excellent communication and cross-functional collaboration abilities

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  Medical device, biotech, or pharmaceutical industry experience
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  Experience supporting audits, CAPA activities, and process improvement initiatives
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  Familiarity with risk assessments and validation documentation practices

Process Validation | Process Verification | FDA Compliance | cGMP | ISO Standards | Validation Protocols | Risk Assessments | CAPA | Technical Writing | Root Cause Analysis | Quality Systems | Continuous Improvement | Manufacturing Validation | Regulatory Compliance