Senior CSV Validation Engineer — Remote

Genovice; Atlanta (GA); On-site; USD 120,000 - 180,000; Part time

Job summary

Genovice is seeking a Senior CSV Validation Engineer for a remote, contract role supporting regulated pharma and biotech environments. You will plan, develop, and maintain computerized system validation for cloud software, edge devices, data integrations, and APIs across lab and manufacturing systems.

You will translate regulatory requirements into practical, risk-based validation deliverables and work with Engineering, Product, and Quality to ensure systems stay validated.

Qualifications

• At least 10 years of computerized system validation experience in GxP environments.
• Ability to create and execute end-to-end CSV deliverables including risk assessments, validation plans and protocols.
• Experience validating software in cloud, edge, and instrument-connected ecosystems.
• Strong knowledge of regulatory requirements and data-integrity principles (ALCOA+).
• Excellent technical writing and validation-record documentation skills.
• Ability to work in a remote, cross-functional environment and coordinate audits.

Responsibilities

• Develop and execute risk-based validation strategies for new systems, features, and integrations.
• Define validation scope based on system complexity, data integrity impact, and regulatory requirements.
• Create and maintain validation deliverables: plans, user requirements, specs, and traceability matrices.
• Prepare and execute IQ/OQ/PQ activities and capture objective evidence.
• Coordinate validation across Engineering, Product, Operations, Quality, and vendors.
• Support audits and customer/regulatory inspections with complete validation documentation.

Skills

GxP risk-based validation

FDA 21 CFR Part 11 knowledge

Regulatory compliance

Test planning and execution

Documentation & traceability

Cross-functional collaboration

Tools

LIMS

MES

ELN

QMS

REST APIs

SQL

Cloud platforms

Job description

Genovice is seeking a Senior CSV Validation Engineer for a remote, contract role supporting regulated pharma and biotech environments. You will plan, develop, and maintain computerized system validation for cloud software, edge devices, data integrations, and APIs across lab and manufacturing systems.

You will translate regulatory requirements into practical, risk-based validation deliverables and work with Engineering, Product, and Quality to ensure systems stay validated.