The Validation Engineer is responsible for planning, executing, and documenting validation activities to ensure that products, processes, equipment, and systems meet regulatory, quality, and customer requirements. This role plays a critical part in maintaining compliance with industry standards and ensuring product reliability and safety.
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Lead validation activities including IQ, OQ, PQ, and CSV (where applicable)
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Develop and approve validation plans, protocols, reports, and traceability matrices
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Ensure compliance with applicable regulations and standards (e.g., FDA, ISO, GxP, ICH, IEC)
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Perform risk assessments (FMEA, risk-based validation approaches)
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Support new product introductions, process changes, and equipment qualifications
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Review and approve change controls, deviations, CAPAs, and SOPs related to validation
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Provide technical guidance and mentorship to junior validation engineers
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Collaborate with cross-functional teams to resolve validation and compliance issues
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Participate in audits and inspections (internal, customer, and regulatory)
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Drive continuous improvement in validation processes and documentation practices