CSV Validation Engineer - GMP & CQV Specialist

Intellectt Inc; Georgia; Vor Ort; USD 70.000 - 90.000; Vollzeit

Zusammenfassung

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.

Qualifikationen

• 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.

Aufgaben

• 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.

Kenntnisse

Engenharia

CSV, CQV, GMP

Pharma regulations (FDA, ICH, ISO)

Automation/control systems (DeltaV, Honeywell)

Documentation skills

Communication skills

Ausbildung

Bachelor’s degree in Engineering or related field

Tools

DeltaV

Honeywell

Rockwell PLC

Siemens

Jobbeschreibung

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.