Senior CSV Engineer - Lead Regulated Systems Validation

Creative Solutions Services, LLC; City of Albany (NY); On-site; USD 110,000 - 150,000; Full time

Job summary

Creative Solutions Services, LLC is seeking a Senior CSV Engineer to lead validation activities for GxP systems in regulated environments. You will guide validation strategy, risk-based approaches, and regulatory compliance across the system lifecycle.

Responsibilities include developing validation deliverables, ensuring 21 CFR Part 11/EU Annex 11 compliance, and mentoring junior engineers while driving continual process improvements.

Qualifications

• Bachelor’s degree in engineering, computer science, life sciences, or related field.
• 5–10+ years in CSV or validation engineering in regulated environments.
• Hands-on validation of LIMS/MES/ERP/lab systems.

Responsibilities

• Lead CSV activities for GxP-regulated systems.
• Develop and review validation deliverables (IQ/OQ/PQ, validation plans, risk assessments).
• Ensure compliance with 21 CFR Part 11, EU Annex 11, and GAMP 5.
• Define risk-based validation strategies and data integrity controls.
• Oversee validation of LIMS, ELN, MES, ERP, CDS, and lab systems.
• Support system implementations, upgrades, and decommissioning from a validation perspective.
• Collaborate with IT/QA/Engineering/stakeholders to ensure compliant deployment.
• Lead change control assessments and validation impact analysis.
• Mentor junior CSV engineers and drive process improvements.

Skills

CSV leadership

GxP validation

Regulatory compliance

Risk-based validation

Vendor/document review

Education

Bachelor's degree in Engineering/CS/Life Sciences

Tools

LabWare

SAP

Oracle

Veeva TrackWise Empower

Job description

Creative Solutions Services, LLC is seeking a Senior CSV Engineer to lead validation activities for GxP systems in regulated environments. You will guide validation strategy, risk-based approaches, and regulatory compliance across the system lifecycle.

Responsibilities include developing validation deliverables, ensuring 21 CFR Part 11/EU Annex 11 compliance, and mentoring junior engineers while driving continual process improvements.