Senior CSV Engineer: Regulatory Validation Leader

Creative Solutions Services, LLC; Boulder (CO); On-site; USD 125,000 - 180,000; Full time

Job summary

Creative Solutions Services, LLC seeks a Senior CSV Engineer to lead validation for GxP systems (LIMS, MES, ERP, ELN). You will ensure compliance with FDA/EU regulations and guide validation strategy across the system lifecycle.

You will mentor junior engineers, drive risk-based validation, and collaborate with IT, QA, and business teams to ensure compliant deployment and data integrity.

Qualifications

• 5–10+ years in Computer System Validation (CSV) or validation engineering.
• Experience in GxP-regulated pharmaceutical, biotech, or medical device environments.
• Authoring and executing IQ/OQ/PQ protocols and validation documentation.
• Strong knowledge of 21 CFR Part 11, EU Annex 11, and GAMP 5 guidelines.
• Experience supporting regulatory audits and inspections.

Responsibilities

• Lead and execute CSV activities for GxP-regulated systems.
• Develop and review validation deliverables (URS, IQ/OQ/PQ, protocols, reports).
• Ensure compliance with FDA and EU regulations.
• Define and implement risk-based validation strategies.
• 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, and business stakeholders.
• Lead change control assessments and determine validation impact.
• Ensure data integrity (ALCOA+) across validated systems.
• Support audits and regulatory inspections with validation documentation.
• Mentor and guide junior CSV engineers and validation staff.
• Drive continuous improvement of validation processes and templates.
• Review vendor documentation to meet regulatory expectations.

Skills

GxP compliance

Regulatory knowledge

Risk-based validation

Leadership

Quality documentation

Education

Bachelor's degree in Engineering, Computer Science, Life Sciences

Tools

LIMS

MES

ERP systems

LabWare

Job description

Creative Solutions Services, LLC seeks a Senior CSV Engineer to lead validation for GxP systems (LIMS, MES, ERP, ELN). You will ensure compliance with FDA/EU regulations and guide validation strategy across the system lifecycle.

You will mentor junior engineers, drive risk-based validation, and collaborate with IT, QA, and business teams to ensure compliant deployment and data integrity.