Senior CSV Lead — Regulated Systems Validation Expert

Creative Solutions Services, LLC; Springfield (IL); On-site; USD 120,000 - 180,000; Full time

Job summary

Creative Solutions Services, LLC seeks an experienced Computer System Validation (CSV) Lead to oversee validation activities for GxP computerized systems. You will manage IQ/OQ/PQ, risk assessments, and regulatory alignment across IT, QA, and manufacturing teams.

The role requires 8–12+ years in CSV within pharma or life sciences, with strong GMP and FDA/EMA knowledge. You will mentor junior engineers and maintain lifecycle documentation per SOPs.

Qualifications

• 8–12+ years of CSV experience in pharma or life sciences
• Strong knowledge of GxP regulations and CSV lifecycle
• Experience validating enterprise systems (LIMS, MES, SAP, etc.)

Responsibilities

• Lead end-to-end CSV activities for GxP computerized systems.
• Develop and review Validation Plans, Protocols, Risk Assessments, Traceability Matrices, and Validation Summary Reports.
• Execute IQ, OQ, and PQ activities.
• Ensure compliance with 21 CFR Part 11, Annex 11, GAMP 5, FDA and EMA requirements.
• Review URS, FS, and DS documents.
• Perform risk assessments using GAMP 5 methodology.
• Manage deviations, CAPAs, change controls, and periodic reviews.
• Support software implementation, upgrades, migrations, and decommissioning.
• Coordinate validation activities with IT, QA, Engineering, Manufacturing, and Business teams.
• Support internal and regulatory audits and inspections.
• Mentor junior CSV engineers and provide guidance.
• Maintain validation lifecycle documentation per SOPs.

Education

Bachelors or Masters in CS/IT/Bio/Pharma/Engineering

Tools

LIMS

MES

ERP SAP

QMS

DMS

SCADA

PLC/HMI

EBR

Job description

Creative Solutions Services, LLC seeks an experienced Computer System Validation (CSV) Lead to oversee validation activities for GxP computerized systems. You will manage IQ/OQ/PQ, risk assessments, and regulatory alignment across IT, QA, and manufacturing teams.

The role requires 8–12+ years in CSV within pharma or life sciences, with strong GMP and FDA/EMA knowledge. You will mentor junior engineers and maintain lifecycle documentation per SOPs.