Senior CSV Validation Engineer — Remote-Ready, GxP

Jobgether; United States; On-site; USD 140,000 - 200,000; Full time

Job summary

Jobgether, on behalf of a partner company, seeks a senior CSV Validation Engineer based in the United States to lead risk‑based validation across cloud applications, edge devices, APIs, databases, and enterprise integrations within GxP environments.

This hands‑on role ensures that validated systems are fit for use, secure, and supported by inspection‑ready evidence, partnering with Engineering, Product, Quality, Operations, suppliers, and customers across the full lifecycle.

Qualifications

• Over 10 years in computerized system validation within pharmaceutical, biotech, or GxP settings.
• Strong knowledge of FDA 21 CFR Part 11, EU GMP Annex 11, PIC/S GMP, GAMP 5, ALCOA+ data integrity.
• Experience applying risk-based validation and Computer Software Assurance to complex systems.
• Hands-on experience with requirements, risk assessments, validation plans, protocols, and IQ/OQ/PQ documentation.
• Experience validating configurable software, SaaS, cloud platforms, and integrated environments.
• Understanding of electronic records, signatures, audit trails, access controls, security, and data migration.

Responsibilities

• Develop and execute risk-based validation strategies for new systems, features, and integrations.
• Create, maintain, and execute validation deliverables and traceability matrices.
• Translate regulatory requirements into testable acceptance criteria with full traceability.
• Validate systems across browser apps, cloud services, APIs, databases, and LIMS/MES/ELN/QMS integrations.
• Assess data flows, transformations, and recovery scenarios to prevent data loss or misattribution.
• Prepare validation packages for audits and regulatory inspections.
• Investigate discrepancies and support CAPAs and deviations.

Skills

CSV validation

Regulatory compliance

Risk-based validation

GxP environments

Cloud/SaaS validation

Technical writing

Cross-functional collaboration

Agile development

APIs & databases

Quality systems

Tools

REST APIs

SQL

Job description

Jobgether, on behalf of a partner company, seeks a senior CSV Validation Engineer based in the United States to lead risk‑based validation across cloud applications, edge devices, APIs, databases, and enterprise integrations within GxP environments.

This hands‑on role ensures that validated systems are fit for use, secure, and supported by inspection‑ready evidence, partnering with Engineering, Product, Quality, Operations, suppliers, and customers across the full lifecycle.