Senior CSV Engineer: Lead GxP System Validation

Creative Solutions Services, LLC; Austin (TX); On-site; USD 120,000 - 180,000; Full time

Job summary

Creative Solutions Services, LLC seeks a Senior CSV Engineer to lead validation activities for computerized systems in regulated settings such as pharmaceutical or medical devices. You will guide validation strategy, risk-based approaches, and regulatory compliance across the system lifecycle.

You will oversee validation of LIMS, MES, ERP, ELN and related laboratory systems while ensuring data integrity, audits readiness, and collaboration with IT, QA, and engineering teams.

Qualifications

• Bachelor's degree in a relevant field.
• 5-10+ years of CSV or validation engineering experience.
• Hands-on validation of LIMS, MES, ERP, or laboratory systems.
• Strong knowledge of 21 CFR Part 11, EU Annex 11, GAMP 5.

Responsibilities

• Lead CSV activities for GxP-regulated systems.
• Develop and review validation deliverables (URS, IQ/OQ/PQ, etc.).
• Ensure regulatory compliance and data integrity (ALCOA+).
• Collaborate with IT, QA, Engineering, and stakeholders.
• Mentor junior CSV engineers and drive process improvements.

Skills

CSV

Regulatory compliance

GxP

Risk-based validation

Documentation

Leadership

Education

Bachelor's degree in Engineering, Computer Science, Life Sciences, or related field

Tools

LabWare

SAP

Oracle

Veeva

TrackWise

Empower

Job description

Creative Solutions Services, LLC seeks a Senior CSV Engineer to lead validation activities for computerized systems in regulated settings such as pharmaceutical or medical devices. You will guide validation strategy, risk-based approaches, and regulatory compliance across the system lifecycle.

You will oversee validation of LIMS, MES, ERP, ELN and related laboratory systems while ensuring data integrity, audits readiness, and collaboration with IT, QA, and engineering teams.