System Validation Engineer

Intellectt Inc; Georgia; On-site; USD 70,000 - 90,000; Full time

Job summary

Intellectt Inc is seeking a Computerized System Validation Engineer I in Social Circle, Georgia, to support validation activities for computerized systems used in pharmaceutical manufacturing. The role is focused on ensuring compliance with GMP, quality, safety, and regulatory standards.

Key responsibilities include preparing validation documents, assisting in system testing, supporting change controls, and participating in risk assessments. Candidates should have a Bachelor’s degree in Engineering and familiarity with pharma regulations and validation protocols.

Qualifications

• Bachelor’s degree in Engineering or related computerized systems field.
• Basic knowledge of CSV, CQV, GMP, and validation lifecycle.
• Understanding of pharma regulations such as FDA, ICH, ISO, EU GMP.
• Experience in a CSV/CQV or GMP-regulated environment preferred.

Responsibilities

• Support CSV and qualification activities for computerized systems.
• Prepare and execute validation documents such as protocols/reports.
• Assist in equipment and system testing to confirm quality requirements.
• Support change controls, deviations, investigations, CAPAs.
• Work with SMEs and cross-functional teams to resolve issues.
• Participate in risk and impact assessments for validation.
• Review and support SOPs to maintain compliance with GMP.
• Support audits and regulatory inspections when required.

Skills

Engenharia

CSV, CQV, GMP

Pharma regulations (FDA, ICH, ISO)

Automation/control systems (DeltaV, Honeywell)

Documentation skills

Communication skills

Education

Bachelor’s degree in Engineering or related field

Tools

DeltaV

Honeywell

Rockwell PLC

Siemens

Job description

Job Title: Computerized System Validation Engineer I

Location: Social Circle, Georgia, USA

Job 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.

Key Responsibilities

• 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.

Skills 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.