Senior CSV Validation Engineer – Regulated Systems (Remote)

Jobgether; Mexico; On-site; PHP 7,481,000 - 11,222,000; Full time

Job summary

Jobgether is seeking a senior CSV Validation Engineer based in Mexico to lead risk-based validation across cloud applications, edge devices, APIs, databases, and enterprise integrations. The role ensures regulated systems are fit for use, secure, and supported by complete evidence.

You will collaborate with Engineering, Product, Quality and Operations to mature validation practices and ensure inspection-ready documentation.

Qualifications

• Deep understanding of FDA 21 CFR Part 11, EU GMP Annex 11, GAMP 5.
• Experience leading CSV activities end-to-end in a GxP setting.
• Ability to translate requirements into testable acceptance criteria.

Responsibilities

• Develop and execute risk-based validation strategies for new systems and features.
• Create and maintain validation deliverables: plans, requirements, specs, risk assessments, protocols, IQ/OQ/PQ docs.
• Ensure traceability of requirements, risks, tests, defects and evidence.
• Assess data flows, transformations and data integrity across complex ecosystems.
• Validate electronic records, signatures, audit trails, access controls and data migration.
• Lead validation impact assessments for releases and changes.
• Maintain validated state via periodic reviews and retirement planning.
• Collaborate with Engineering, Product, Quality, Operations, suppliers and customers.

Skills

Regulatory knowledge

Validation leadership

Documentation

Risk assessment

Job description

Jobgether is seeking a senior CSV Validation Engineer based in Mexico to lead risk-based validation across cloud applications, edge devices, APIs, databases, and enterprise integrations. The role ensures regulated systems are fit for use, secure, and supported by complete evidence.

You will collaborate with Engineering, Product, Quality and Operations to mature validation practices and ensure inspection-ready documentation.