Lead CSV Engineer – GxP Validation & Compliance Expert

Creative Solutions Services, LLC; Fort Smith (AR); On-site; USD 110,000 - 150,000; Full time

Job summary

Creative Solutions Services, LLC in Fort Smith, AR seeks a Senior CSV Engineer to lead validation of GxP systems (LIMS, MES, ERP) across regulated environments, ensuring FDA/EU compliance and data integrity.

You will mentor junior engineers, develop validation plans including IQ/OQ/PQ, and collaborate with QA, IT, and engineering to drive risk-based validation and continuous process improvement.

Qualifications

• Requires a Bachelor's degree and 5–10+ years of CSV or validation engineering experience in GxP environments.
• Experience validating LIMS, MES, ERP, or lab systems in regulated settings.
• Strong knowledge of 21 CFR Part 11, EU Annex 11, and GAMP 5 guidelines.

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 data integrity and regulatory compliance across validated systems.
• Define risk-based validation strategies and oversee changes impacting validation.
• Mentor junior CSV engineers and drive process improvements.

Skills

CSV expertise

Regulatory compliance

Risk assessment

Validation planning

Cross-functional collaboration

Education

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

Tools

LIMS

ELN

MES

ERP

CDS

Job description

Creative Solutions Services, LLC in Fort Smith, AR seeks a Senior CSV Engineer to lead validation of GxP systems (LIMS, MES, ERP) across regulated environments, ensuring FDA/EU compliance and data integrity.

You will mentor junior engineers, develop validation plans including IQ/OQ/PQ, and collaborate with QA, IT, and engineering to drive risk-based validation and continuous process improvement.