Quality Engineer - Software & Process Validation

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

Role Summary

The Software and Process Validation engineer is responsible for ensuring that computerized systems, manufacturing processes, equipment, utilities, facilities, and associated quality systems consistently perform as intended and comply with regulatory, quality, and business requirements. This role supports the full validation lifecycle, including planning, risk assessment, qualification, testing, documentation, change management, and maintenance of the validated state.

Key Responsibilities

• Lead software validation for new systems and changes, including requirements, risk assessments, testing, traceability, deviations, reports, integrations, and data migrations.
• Support audits, inspections, and quality investigations
• Perform validation risk assessment utilizing the appropriate risk-validation and CSA principles
• Evaluate data integrity, access controls, audit trails, electronic records and signatures, security, backup and recovery, and continued validated-state requirements.
• Support process and equipment validation, including IQ/OQ/PQ, PPQ, cleaning, utilities, facilities, technology transfer, and new product introduction.
• Apply change control, CAPA, deviation, document-control, and risk-management requirements; monitor milestones, escal…?
• Lead validation of GxP computerized systems.
• Develop and execute validation plans.
• Create and review: URS, risk assessments; traceability matrices; test scripts and validation reports.
• Assess data integrity controls, audit trails, electronic records, and electronic signatures.
• Support software implementations, upgrades, integrations, cloud applications, and system changes.

Required Qualifications

• Bachelor’s degree in Engineering, Computer Science, Information Systems, Life Sciences, Quality, or a related technical field.
• At least 3 years of validation, quality engineering, quality systems, software quality, or related experience in a regulated environment.
• Hands-on computerized system validation experience covering requirements, risk assessment, testing, traceability, deviations, and validation reporting.
• Working knowledge of GxP/cGMP, FDA, ISO, data integrity, change control, CAPA, technical writing, and project execution.

Preferred Qualifications

• Experience validating enterprise eQMS, laboratory, manufacturing, ERP, cloud/SaaS, reporting, integration, or data-migration solutions.
• Experience with process/product validation, equipment, facilities and utilities qualification, cleaning validation.
• Knowledge of ISO 9001, cGMP, FDA 21 CFR Parts 11, 210, 211, 820, Health Canada, ICH, Pic/s guidance, MHRA Data integrity
• Multilingual communication capability, preferably English plus Spanish or Portuguese, and willingness to travel to manufacturing locations