System Validation Engineer

Job Title:

Computerized System Validation Engineer I

Location:

Social Circle, Georgia, USAJob Summary

The CSV Engineer supports validation activities for computerized systems used in pharmaceutical/biopharmaceutical manufacturing. The role focuses on ensuring systems, equipment, automation platforms, and validation documents meet GMP, quality, safety, and regulatory standards
.

• Support CSV and qualification activities for computerized systems, facilities, utilities, equipment, and automation systems used in production.
• Prepare and execute validation documents such as commissioning, qualification, and validation protocols/reports.
• Assist in equipment and system testing to confirm that systems meet quality, safety, reliability, and performance requirements.
• Support change controls, deviations, investigations, and CAPAs by providing technical validation input and documentation support.
• Work with SMEs and cross-functional teams to execute testing strategies and resolve validation-related issues.
• Participate in risk and impact assessments to identify validation requirements and system risks.
• Review and support SOPs and validation assessments to maintain compliance with GMP standards.
• Support audits and regulatory inspections as part of the Engineering Validation team when required.

• Bachelor’s degree in Engineering or related computerized systems field.
• Basic knowledge of CSV, CQV, GMP, and validation lifecycle
  .
• Understanding of pharma regulations/guidelines such as FDA, ICH, ISO, EU GMP, ISPE, PDA
  .
• Knowledge of automation/control systems like DeltaV, Honeywell, Rockwell PLC, Siemens is a plus.
• Good documentation, writing, and communication skills.
• Ability to work with change control, deviations, CAPA, SOPs, and validation protocols
  .
• Experience CSV/CQV or GMP-regulated environment preferred.