Remote CSV Engineer - GxP Validation & Data Integrity Lead

Bridgenext; Argentina; Remote; ARS 900,000 - 1,500,000; Full time

Job summary

Bridgenext in LATAM is seeking an experienced CSV Validation Engineer to support validation, compliance, and quality management in a GxP-regulated environment. You will prepare documentation, including Validation Plans, URS, IQ/OQ/PQ protocols and Traceability Matrices, to meet regulatory requirements.

You will collaborate with cross-functional teams to ensure compliance, drive best practices in validation, risk assessment, and data integrity across software applications and systems.

Qualifications

• Bachelor's degree in computer science or related field.
• 5+ years of CSV validation experience.
• Strong knowledge of GxP, validation principles, and data integrity.
• Experience with risk-based CSV strategies.
• Excellent written and verbal English communication.

Responsibilities

• Lead risk-based validation strategies for GxP systems throughout the lifecycle.
• Assess impact of system events on validated state and data reliability.
• Lead validation execution and ensure appropriate documentation.
• Support change control, upgrades, migrations, and releases.
• Support and conduct periodic reviews.
• Evaluate data lifecycles and data flow from creation to archive.
• Provide CSV and data integrity guidance during vendor testing and audits.
• Collaborate with business, quality, IT, and regulatory stakeholders.

Skills

CSV Validation

GxP compliance

Risk assessment

Documentation writing

Data integrity

Regulatory knowledge

Excellent English communication

Education

Bachelor’s degree in computer science

Tools

Jira

Job description

Bridgenext in LATAM is seeking an experienced CSV Validation Engineer to support validation, compliance, and quality management in a GxP-regulated environment. You will prepare documentation, including Validation Plans, URS, IQ/OQ/PQ protocols and Traceability Matrices, to meet regulatory requirements.

You will collaborate with cross-functional teams to ensure compliance, drive best practices in validation, risk assessment, and data integrity across software applications and systems.