GxP Validation Engineer – Software & Process Systems

Ecolab; Buenos Aires; On-site; ARS 2,000,000 - 3,500,000; Full time

Job summary

Ecolab in Buenos Aires seeks a Software and Process Validation Engineer to own the validation lifecycle for computerized systems, manufacturing processes, equipment, utilities, facilities and related quality systems, ensuring compliance with regulatory and business requirements and maintaining the validated state.

You will lead IQ/OQ/PQ activities, risk assessments, traceability, data integrity controls, audits, and change management, and support software implementations, upgrades and data

Qualifications

• 3+ years of validation/quality engineering in regulated environments.
• Experience with IQ/OQ/PQ, deviation handling and validation reporting.
• Knowledge of data integrity, access controls and electronic records.
• Experience in software validation for enterprise systems is a plus.

Responsibilities

• Lead software validation for new systems and changes; manage requirements, testing, traceability and reports.
• Support audits, inspections and quality investigations.
• Perform validation risk assessments using CSA principles.
• Evaluate data integrity controls, audit trails and electronic signatures.
• Support software implementations, upgrades, and data migrations.

Skills

Validation engineering

Quality systems

GxP compliance

Risk assessment

Documentation

Education

Bachelor's degree in Engineering or related field

Tools

eQMS

ERP systems

Cloud applications

Job description

Ecolab in Buenos Aires seeks a Software and Process Validation Engineer to own the validation lifecycle for computerized systems, manufacturing processes, equipment, utilities, facilities and related quality systems, ensuring compliance with regulatory and business requirements and maintaining the validated state.

You will lead IQ/OQ/PQ activities, risk assessments, traceability, data integrity controls, audits, and change management, and support software implementations, upgrades and data