Manufacturing Data Remediation Engineer
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Key Responsibilities
• Assess, identify, and remediate inconsistencies, inaccuracies, and gaps in manufacturing data across systems and records.
• Develop and implement remediation strategies for legacy and operational data to meet regulatory and quality requirements.
• Collaborate with manufacturing, quality assurance, IT, and engineering teams to collect, validate, and cleanse data.
• Ensure data integrity and compliance with relevant standards (GMP, FDA, ISO, etc.).
• Document remediation plans, procedures, and outcomes, providing clear evidence of compliance for audits and inspections.
• Analyze manufacturing data to identify areas for improvement and standardization.
• Support root cause investigations for data-related deviations and implement corrective actions (CAPA).
• Train staff in best practices for manufacturing data management, remediation, and documentation.
• Participate in system upgrades, migrations, or new technology implementations, ensuring legacy data is appropriately remediated and transferred.
• Assist with audit and inspection readiness by providing accurate and compliant data records.
Requirements:
• Bachelor’s or Master’s degree in Engineering, Data Science, Information Technology, or related field.
• [Insert Years] experience in manufacturing data management, remediation, or related roles within regulated environments (pharma, biotech, medical device, industrial, etc.).
• Strong understanding of data integrity principles and regulatory requirements (GMP, FDA, ISO).
• Experience with data cleansing, validation, and quality assurance methodologies.
• Proficiency in using manufacturing databases, MES, ERP, and digital documentation tools.
• Excellent analytical, documentation, and communication skills.
• Ability to manage multiple remediation projects in cross-functional teams.
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