CSV & Digital Systems Quality Engineer

SGS Consulting; Tallahassee (FL); On-site; USD 90,000 - 120,000; Full time

Job summary

SGS Consulting is seeking a quality-focused professional to lead CSV validation activities. You will review lifecycle documents, enforce GxP controls, and ensure FDA/EMA readiness for MES/EBR systems, process historians, and analytics tools.

The role requires strong documentation skills, risk-based validation judgment, and collaboration with Engineering, Automation, and IT teams to deliver compliant, inspectable validation strategies.

Qualifications

• Master’s degree in Engineering, CS, Life Sciences or related field.
• 3–5 years in pharmaceutical or regulated manufacturing.
• Minimum 2 years in quality organization.
• 3+ years CSV experience reviewing and approving validation documentation.

Responsibilities

• Review and approve CSV lifecycle documents per GAMP 5.
• Ensure data integrity and 21 CFR Part 11 compliance.
• Evaluate changes via change control and assess GxP impact.
• Support validation, re-validation activities and inspections.
• Act as Quality reviewer/approver for MES/EBR platforms.
• Collaborate with Engineering, IT, and Operations for compliant projects.
• Provide input during FAT/SAT and commissioning phases.

Skills

CSV validation

GAMP 5

Regulatory compliance

Documentation review

Quality assurance

Education

Master’s degree in Engineering/CS/Life Sciences

Tools

WERUM PAS-X

OSIsoft PI

Seeq

Power BI

Job description

SGS Consulting is seeking a quality-focused professional to lead CSV validation activities. You will review lifecycle documents, enforce GxP controls, and ensure FDA/EMA readiness for MES/EBR systems, process historians, and analytics tools.

The role requires strong documentation skills, risk-based validation judgment, and collaboration with Engineering, Automation, and IT teams to deliver compliant, inspectable validation strategies.