Role Overview:
We are seeking a Manufacturing Data Remediation Engineer to support manufacturing operations by remediating and optimizing data, ensuring compliance, and improving data integrity across systems. The ideal candidate will have hands-on experience in data management within manufacturing environments and a solid understanding of regulatory requirements.
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.