Manufacturing Data Integrity Engineer (GMP/FDA)

EFOR; Waterford; On-site; EUR 60,000 - 90,000; Full time

Job summary

EFOR is seeking a Manufacturing Data Remediation Engineer to support manufacturing operations by remediating and optimizing data, ensuring compliance, and improving data integrity across systems.

The role requires hands-on experience in data management within regulated environments, strong knowledge of GMP, FDA, ISO, and the ability to collaborate with manufacturing, QA, IT, and engineering to collect, validate, and cleanse data.

Qualifications

• Bachelor’s or Master’s degree in Engineering, Data Science, Information Technology, or related field.
• Experience in manufacturing data management, remediation in regulated environments (pharma, biotech, medical device, 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.

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, QA, 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.

Skills

Data management

Regulatory compliance

Data cleansing

Documentation

Analytical

Communication

Education

Bachelor’s or Master’s degree in Engineering, Data Science, IT or related field

Tools

MES

ERP

Document management tools

Job description

EFOR is seeking a Manufacturing Data Remediation Engineer to support manufacturing operations by remediating and optimizing data, ensuring compliance, and improving data integrity across systems.

The role requires hands-on experience in data management within regulated environments, strong knowledge of GMP, FDA, ISO, and the ability to collaborate with manufacturing, QA, IT, and engineering to collect, validate, and cleanse data.