Senior CSV Engineer: Regulated Systems Validation Lead

Katalyst CRO; Chicago (IL); On-site; USD 110,000 - 170,000; Full time

Job summary

Katalyst CRO seeks a Senior CSV Engineer to lead validation for computerized systems in regulated environments. You will guide validation strategy, ensure compliance with FDA, EU, and global requirements, and mentor junior engineers across system lifecycle.

Applicants should have 5-10+ years in CSV, strong GxP experience, and hands-on validation of LIMS, MES, ERP, or lab systems. Collaboration with IT, QA, and Stakeholders is essential for compliant deployments.

Qualifications

• Bachelor's degree in Engineering, Computer Science, Life Sciences, or related field.
• 5-10+ years of experience in CSV or validation engineering.
• Strong experience in GxP-regulated pharmaceutical, biotech, or medical device environments.
• Hands-on validation of LIMS, MES, ERP, or laboratory systems.
• Strong knowledge of 21 CFR Part 11, EU Annex 11, and GAMP 5 guidelines.
• Experience authoring and executing IQ/OQ/PQ protocols and validation documentation.
• Strong understanding of risk-based validation and data integrity principles.
• Experience supporting regulatory audits and inspections.

Responsibilities

• Lead and execute CSV activities for GxP-regulated systems.
• Develop and review validation deliverables (validation plans, URS, FS, DS, IQ/OQ/PQ, reports).
• Ensure compliance with FDA 21 CFR Part 11, EU Annex 11, GAMP 5, and GxP regs.
• Define and implement risk-based validation strategies for computerized systems.
• Oversee validation of LIMS, ELN, MES, ERP, CDS, and lab systems.
• Support system implementations, upgrades, decommissioning from a validation view.
• Collaborate with IT, QA, Eng, and stakeholders for compliant deployment.
• Lead change control assessments and validate impact of changes.
• Ensure data integrity (ALCOA+) across validated systems.
• Support audits and regulatory inspections with documentation and justification.
• Mentor junior CSV engineers and validation team members.
• Drive continuous improvement of validation processes, templates, standards.
• Review vendor docs to ensure regulatory expectations prior to deployment.

Skills

Leadership

Regulatory knowledge

Risk assessment

Data integrity

Technical writing

Education

Bachelor's degree in Engineering

Tools

LabWare

SAP

Oracle

Veeva

TrackWise

Empower

Job description

Katalyst CRO seeks a Senior CSV Engineer to lead validation for computerized systems in regulated environments. You will guide validation strategy, ensure compliance with FDA, EU, and global requirements, and mentor junior engineers across system lifecycle.

Applicants should have 5-10+ years in CSV, strong GxP experience, and hands-on validation of LIMS, MES, ERP, or lab systems. Collaboration with IT, QA, and Stakeholders is essential for compliant deployments.