Senior CSV Engineer — Regulated Systems Validation Leader

Creative Solutions Services, LLC; St. Louis (MO); On-site; USD 120,000 - 160,000; Full time

Job summary

Creative Solutions Services, LLC is seeking a Senior CSV Engineer to lead validation of GxP-regulated systems, including LIMS, MES, ERP, and ELN. You will define risk-based strategies, author validation documentation, and ensure data integrity across validated systems.

The role requires strong leadership, collaboration with IT, QA, engineering, and business stakeholders, and experience supporting regulatory audits and inspections.

Qualifications

• Requires 5–10+ years of CSV or validation engineering experience.
• Experience in GxP-regulated pharma/biotech/medical device environments.
• Experience authoring IQ/OQ/PQ protocols and validation documentation.
• Strong knowledge of data integrity and 21 CFR Part 11.

Responsibilities

• Lead CSV activities for GxP-regulated systems.
• Develop and review validation plans, URS, FS, DS, risk assessments, IQ/OQ/PQ.
• Ensure compliance with FDA/EU/GAMP 5 and GxP regs.
• Define risk-based validation strategies and oversee system validation.
• Mentor junior CSV engineers and coordinate cross-functional teams.
• Support audits, vendor documentation, and validation lifecycle.

Skills

CSV expertise

Regulatory compliance

Leadership

Cross-functional collaboration

Documentation

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 is seeking a Senior CSV Engineer to lead validation of GxP-regulated systems, including LIMS, MES, ERP, and ELN. You will define risk-based strategies, author validation documentation, and ensure data integrity across validated systems.

The role requires strong leadership, collaboration with IT, QA, engineering, and business stakeholders, and experience supporting regulatory audits and inspections.